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A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD) (CREAD 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114657
Recruitment Status : Terminated (This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.)
First Posted : April 14, 2017
Results First Posted : June 12, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Crenezumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 806 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease
Actual Study Start Date : March 29, 2017
Actual Primary Completion Date : June 11, 2019
Actual Study Completion Date : June 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
Drug: Placebo
Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Experimental: Crenezumab
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
Drug: Crenezumab
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.




Primary Outcome Measures :
  1. Change From Baseline to Week 77 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scale Score [ Time Frame: Baseline, Week 77 ]
    The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline for this primary endpoint. Data after 29 January 2019 are censored for the primary and secondary efficacy analyses to avoid potential biases due to investigators, participants, raters, etc. being potentially influenced by early closure of the study due to lack of efficacy.


Secondary Outcome Measures :
  1. Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) Subscale Score [ Time Frame: Baseline, Week 77 ]
    The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  2. Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 11 (ADAS-Cog-11) Subscale Score [ Time Frame: Baseline, Week 77 ]
    The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  3. Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS) [ Time Frame: Baseline, Week 77 ]
    The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  4. Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE) [ Time Frame: Baseline, Week 77 ]
    The MMSE is a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target 6 areas: orientation, registration, attention, short-term recall, language and constructional praxis/visuospatial abilities. The scores on the MMSE range from 0 to 30, with higher scores indicating better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  5. Change From Baseline to Week 77 on Function as Assessed by (ADCS-ADL) Total Score [ Time Frame: Baseline, Week 77 ]
    The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  6. Change From Baseline to Week 77 on Function as Assessed by (ADCS-iADL) Instrumental Score [ Time Frame: Baseline, Week 77 ]
    The ADCS-iADL (Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living) measures activities such as using the telephone, managing finances and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  7. Change From Baseline to Week 77 on Function as Assessed by the Functional Activities Questionnaire (FAQ) Total Score [ Time Frame: Baseline, Week 77 ]
    The Functional Activities Questionnaire (FAQ) is an instrument consisting of 10 items and assesses instrumental, social and cognitive functioning. The score range is from 0 to 30 with higher scores representing higher impairment. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  8. Change From Baseline to Week 77 on a Measure of Dependence Level Assessed From the ADCS-ADL Score [ Time Frame: Baseline, Week 77 ]
    The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  9. Change From Baseline to Week 53 on Behavior in Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Score [ Time Frame: Baseline, Week 53 ]
    The NPI-Q evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavioral disturbances and appetite/eating abnormalities. The severity of each neuropsychiatric symptom is rated on a 3-point scale (mild, moderate and marked). The total severity score range is from 0 to 36 with higher scores representing higher severity. Difference in mean change from Baseline to Week 53 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures adjusting for disease severity, APOEe4 status, geographic region and the use/non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  10. Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score [ Time Frame: Baseline, Week 77 ]
    The QoL-AD (Quality of Life - Alzheimer's Disease) scale assesses QoL in participants who have dementia. The QoL-AD consists of 13 items covering aspects of participants' relationships with friends and family, physical condition, mood, concerns about finances and overall assessment of QoL. Items are rated on 4-point Likert-type scales ranging from 1 [poor] to 4 [excellent]. The score range is from 13 to 52, with higher scores indicating a better QoL. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  11. Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score [ Time Frame: Baseline, Week 53 ]
    The ZCI-AD is a modified version of the Zarit Burden Interview, which was originally designed to reflect the stresses experienced by caregivers of people with dementia. This modified version includes slight modifications in item and title wording (e.g., removal of "your relative" to refer directly to the patient, removal of "burden" from title) and the use of 11-point numerical rating scales. The ZCI-AD scale consists of a total of 30 items. Total scores will be calculated with a total score range from 0 to 300 (higher scores indicate a higher burden on the caregiver). The difference in mean change from Baseline to Week 53 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  12. European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Participants [ Time Frame: Baseline, Week 77 ]
    The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  13. European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Caregivers [ Time Frame: Baseline, Week 77 ]
    The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  14. Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs) [ Time Frame: Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks). ]
    An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

  15. Percentage of Participants With Anti-Crenezumab Antibodies [ Time Frame: Baseline up to Week 105 ]
    Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.

  16. Serum Concentration of Crenezumab [ Time Frame: Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 13 (Pre-dose), 37 (Pre-dose), 53 (Pre-dose) and 77 (Pre-dose) (infusion length = as per the Pharmacy Manual) ]
    Serum concentration data for Crenezumab will be tabulated and summarized. Descriptive summary statistics will include the arithmetic mean and SD. Since a sparse PK sampling design is being used, population (non-linear mixed-effects) modeling will be used to analyze the dose concentration-time data of crenezumab. Information from other clinical studies may be incorporated to establish the PK model. Please note that Post-dose samples were not collected at Weeks 5, 13, 37, 53 and 77.

  17. Plasma Amyloid Beta (Abeta) 40 Concentrations [ Time Frame: Week 1 Day 1; Weeks 53 ]
    Plasma Abeta 40 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that Pre-dose samples were only collected at Weeks 1 and 53.

  18. Plasma Amyloid Beta (Abeta) 42 Concentrations [ Time Frame: Week 1 Day 1; Weeks 53 ]
    Plasma Abeta 42 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that Pre-dose samples were only collected at Weeks 1 and 53.

  19. Percentage Change From Baseline to Week 105 in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, Week 105 ]
    Percentage Change in Whole Brain Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  20. Percentage Change From Baseline to Week 105 in Ventricle Volume as Determined by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, Week 105 ]
    Percentage Change in Ventricle Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

  21. Percentage Change From Baseline to Week 105 in Hippocampal Volume as Determined by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, Week 105 ]
    Percentage Change in Hippocampal Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight between 40 and 120 kilograms (Kg) inclusive
  • Availability of a person (referred to as the "caregiver") who in the investigator's judgment:
  • Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities
  • Fluency in the language of the tests used at the study site
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
  • Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid(1-42) test system or amyloid PET scan by qualitative read by the core/central PET laboratory
  • Demonstrated abnormal memory function at screening (up to 4 weeks before screening begins) or screening (FCSRT cueing index =<0.67 AND free recall =<27)
  • Screening mini mental state examination (MMSE) score of greater than or equal to (>=) 22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0
  • Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment (MCI)
  • If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening
  • Participant must have completed at least 6 years of formal education after the age of 5 years

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
  • History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
  • At risk of suicide in the opinion of the investigator
  • Any abnormal MRI findings, such as presence of cerebral vascular pathology, cortical stroke, etc or inability to tolerate MRI procedures or contraindication to MRI
  • Unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney or liver disease
  • Uncontrolled hypertension
  • Screening hemoglobin A1c (HbA1C) >8%
  • Poor peripheral venous access
  • History of cancer except:

If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy

- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114657


Locations
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United States, Arizona
Imaging End Points Clinical Research
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Health Initiatives Research, PLLC
Fayetteville, Arkansas, United States, 72703
Clinical Trials Inc.
Little Rock, Arkansas, United States, 72205
United States, California
Neuro-Therapeutics Inc.
Pasadena, California, United States, 91105
Desert Valley Medical Group
Rancho Mirage, California, United States, 92270
Anderson Clinical Research, Inc.
Redlands, California, United States, 92374
University of California, Davis; Alzheimers Disease Center, Department of Neurology
Sacramento, California, United States, 95817
UCSF - Memory and Aging Center
San Francisco, California, United States, 94158
United States, Colorado
MCB Clinical Research Centers
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20057
United States, Florida
JEM Research LLC
Atlantis, Florida, United States, 33462
Bradenton Research Center
Bradenton, Florida, United States, 34205
Neuropsychiatric Research; Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States, 33414
Renstar Medical Research
Ocala, Florida, United States, 34470
Bioclinica Research
Orlando, Florida, United States, 32806
Progressive Medical Research
Port Orange, Florida, United States, 32127
United States, Georgia
Columbus Memory Center
Columbus, Georgia, United States, 31909
United States, Louisiana
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States, 70601
United States, Massachusetts
Alzheimers Disease Center; Neurology
Winchester, Massachusetts, United States, 01890
United States, Minnesota
Health Partners Institute for Education and Research
Saint Paul, Minnesota, United States, 55130
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Nebraska
University of Nebraska Medical Center; Dept of Neurological Sciences
Omaha, Nebraska, United States, 68198-8440
United States, Nevada
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States, 89106
United States, New Jersey
The Cognitive and Research Center of New Jersey
Summit, New Jersey, United States, 07081
Advanced Memory Research Institute of NJ
Toms River, New Jersey, United States, 08755
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
United States, North Carolina
Behavioral Health Research
Charlotte, North Carolina, United States, 28211
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219
Ohio State University; College of Medicine
Columbus, Ohio, United States, 43210
Dayton Center for Neuro Disorders
Dayton, Ohio, United States, 45459
United States, Oregon
Summit Research Network Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Northeastern Pennsylvania Memory
Plains, Pennsylvania, United States, 18705
Abington Neurological Associates
Willow Grove, Pennsylvania, United States, 19090
United States, Tennessee
Neurology Clinic PC
Cordova, Tennessee, United States, 38018
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Gadolin Research, LLC
Beaumont, Texas, United States, 77702
Texas Neurology PA
Dallas, Texas, United States, 75214
Kerwin Research Center, LLC
Dallas, Texas, United States, 75231
Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine
Houston, Texas, United States, 77030
Clinical Trials of Texas, Inc
San Antonio, Texas, United States, 78229
United States, Virginia
Sentara Medical Group
Norfolk, Virginia, United States, 23507
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States, 23294
Argentina
Hospital Italiano
Buenos Aires, Argentina, C1181ACH
Universidad Maimonides
Caba, Argentina, C1405BCK
DAMIC
Cordoba, Argentina, X500 3DCE
Australia, New South Wales
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Central Coast Neurosciences Research
Erina, New South Wales, Australia, 2250
Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care
Hornsby, New South Wales, Australia, 2077
Australia, South Australia
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, Australia, 5011
Belgium
AZ Sint Jan
Brugge, Belgium, 8000
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Brazil
CCBR - Brasilia
Brasilia, DF, Brazil, 70200-730
Hospital das Clinicas - UFMG
Belo Horizonte, MG, Brazil, 31270-901
Instituto de Neurologia de Curitiba
Curitiba, PR, Brazil, 81210-310
Centro Psiquiatria Sandra Ruschel Ltda
Rio de Janeiro, RJ, Brazil, 22270-060
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil
Clínica Dr. Norton Sayeg LTDA - EPP
Sao Paulo, SP, Brazil, 04534-011
Canada, British Columbia
OCT Research ULC
Kelowna, British Columbia, Canada, V1Y 1Z9
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8
Canada, Nova Scotia
True North Clinical Research-Halifax
Halifax, Nova Scotia, Canada, B3S 1M7
True North Clinical Research Kentville
Kentville, Nova Scotia, Canada, B4N 5E3
Canada, Ontario
Providence Care; Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Parkwood Hospital; Geriatric Medicine
London, Ontario, Canada, N6C 5J1
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada, K9H 2P4
The Centre for Memory and Aging
Toronto, Ontario, Canada, M4G 3E8
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1N9
Devonshire Clinical Research Inc.
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada, J4V 2J2
Canada
ALPHA Recherche Clinique
Quebec, Canada, G3K 2P8
China
Beijing Union Hospital
Beijing, China, 100730
Tianjin Medical University General Hospital
Tianjin (天津), China, 300052
Denmark
Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken
Aarhus N, Denmark, 8200
Rigshospitalet, Hukommelsesklinikken
København Ø, Denmark, 2100
Estonia
Laane-Tallinna Keskhaigla
Tallinn, Estonia, 10617
France
Hopital Pellegrin; Cmrr Aquitaine
Bordeaux, France, 33076
Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie
Colmar, France, 68000
Hopital Roger Salengro; Service de Neurologie
Lille, France
CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique
Limoges, France, 87042
Hopital Broca
Paris, France, 75013
CH Pitie Salpetriere; IM2A
Paris, France, 75651
Hôpital Maison Blanche
Reims, France, 51092
CHU Rennes - Hopital Pontchaillou
Rennes, France, 35033
CHU de Rouen Hopital; Service de Neurologie
Rouen, France, 76031
Hop Guillaume Et Rene Laennec; Cmrr St Herblain
St Herblain, France, 44800
Hopital des Charpennes
Villeurbanne, France, 69100
Germany
ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic
Berlin, Germany, 13125
Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik
Frankfurt, Germany, 60528
Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie
Freiburg, Germany, 79106
Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie
Homburg/Saar, Germany, 66421
PANAKEIA - Arzneimittelforschung Leipzig GmbH
Leipzig, Germany, 04275
Pharmakologisches Studienzentrum
Mittweida, Germany, 09648
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, Germany, 81675
Israel
Rambam Medical Center
Haifa, Israel, 3109601
Sheba Medical Center; Psychiatry Department
Ramat Gan, Israel, 5262100
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv, Israel, 6423906
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia
Roma, Lazio, Italy, 00133
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Roma, Lazio, Italy, 00185
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Roma, Lazio, Italy, 00186
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
Brescia, Lombardia, Italy, 25125
Irccs Multimedica Santa Maria; Unita' Di Neurologia
Castellanza, Lombardia, Italy, 21053
IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria
Milano, Lombardia, Italy, 20132
Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia
Milano, Lombardia, Italy, 20133
Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa
Milano, Lombardia, Italy, 20148
Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer
Passirana, Lombardia, Italy, 20017
IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA
Pozzilli, Molise, Italy, 86077
AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria
Torino, Piemonte, Italy, 10126
A.O. Universitaria Pisana; Neurologia
Pisa, Toscana, Italy, 56126
Japan
National Center for Geriatrics and Gerontology
Aichi, Japan, 474-8511
Inage Neurology and Memory Clinic
Chiba, Japan, 263-0043
Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, Japan, 739-0696
Tsukazaki Hospital
Hyogo, Japan, 671-1227
Iwate Medical University Hospital
Iwate, Japan, 028-3695
Kagawa Prefectural Central Hospital
Kagawa, Japan, 760-8557
Fujisawa City Hospital
Kanagawa, Japan, 251-8550
National Hospital Organization Sagamihara National Hospital
Kanagawa, Japan, 252-0392
Ijinkai Takeda General Hospital
Kyoto, Japan, 601-1495
Rakuwakai Otowarehabilitation Hospital
Kyoto, Japan, 607-8113
National Hospital Organization Matsumoto Medical Center
Nagano, Japan, 399-8701
Katayama Medical Clinic
Okayama, Japan, 710-0813
Osaka University Hospital
Osaka, Japan, 565-0871
Asakayama General Hospital
Osaka, Japan, 590-0018
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Japan, 420-8688
Kanto Central Hospital
Tokyo, Japan, 158-8531
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Shinjuku Research Park Clinic
Tokyo, Japan, 169-0073
Tokyo Metropolitan Geriatric Hospital
Tokyo, Japan, 173-0015
National Center of Neurology and Psychiatry
Tokyo, Japan, 187-8551
Tokyo Medical University Hachioji Medical Center
Tokyo, Japan, 193-0998
Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of, 49201
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 13605
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Hanyang University Seoul Hospital
Seoul, Korea, Republic of, 04763
Konkuk University Medical Center
Seoul, Korea, Republic of, 05030
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Seoul St Mary's Hospital
Seoul, Korea, Republic of, 06591
Borame Medical Center
Seoul, Korea, Republic of, 07061
Norway
Akershus universitetssykehus HF; Nevroklinikken S203
Lørenskog, Norway, 1478
Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken
Oslo, Norway, 0450
Peru
Clinica Internacional; Unidad De Investigacion
Lima, Peru, 15001
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
Lima, Peru, Lima 01
Poland
NZOZ Dom Sue Ryder
Bydgoszcz, Poland, 85-023
Centrum Medyczne Euromedis Sp. z o.o.
Szczecin, Poland, 70-111
Centrum Medyczne NeuroProtect
Warszawa, Poland, 01-684
NZOZ WCA
Wrocław, Poland, 53-659
Portugal
Hospital de Braga; Servico de Neurologia
Braga, Portugal, 4710-243
HUC; Servico de Neurologia
Coimbra, Portugal, 3000-075
Hospital Pedro Hispano; Servico de Neurologia
Matosinhos, Portugal, 4464-513
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto, Portugal, 4099-001
Russian Federation
LLC Baltic Medicine
Saint-Petersburg, Sankt Petersburg, Russian Federation, 194356
State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita
Ekaterinburg, Sverdlovsk, Russian Federation, 620030
State Autonomous Healthcare Institution "Republican Clinical Neurological Center
Kazan, Russian Federation, 420021
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan, Russian Federation, 420101
Institution of RAMS (Mental Health Research Center of RAMS)
Moscow, Russian Federation, 115522
City Clinical Psychiatry Hospital #1
Nizhny Novgorod, Russian Federation, 603155
St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy
St Petersburg, Russian Federation, 190121
Nebbiolo Center for Clinical Trials
Tomsk, Russian Federation, 634009
Serbia
Clinic for Mental disorders Dr Laza Lazarevic
Belgrade, Serbia, 11000
Neurology clinic, Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinic for neurology, Clinical Center Kragujevac
Kragujevac, Serbia, 34000
South Africa
Private Practice; the Osteoporosis Clinic
Johannesburg, South Africa, 2196
Spain
Hospital General Universitario de Elche; Servicio de Neurología
Elche, Alicante, Spain, 03203
Fundació ACE
BArcelon, Barcelona, Spain, 08034
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Valles, Barcelona, Spain, 8195
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrassa, Barcelona, Spain, 08222
Hospital Virgen del Puerto. Servicio de Neurología
Plasencia, Caceres, Spain, 10600
Hospital Universitario Marques de Valdecilla; Servicio de Neurología
Santander, Cantabria, Spain
Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies
Salt, Girona, Spain, 17090
Policlínica Guipuzkoa; Servicio de Neurología
Donosti-San Sebastián, Guipuzcoa, Spain, 20014
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital San Pedro; Servicio de Neurología
Logroño, LA Rioja, Spain, 26006
Hospital Quiron de Madrid; Servicio de Neurologia
Pozuelo de Alarcon, Madrid, Spain, 28223
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarra, Spain, 31008
CAE Oroitu
BaraKaldo, Vizcaya, Spain, 48903
Hospital Perpetuo Socorro, Servicio de Geriatria
Albacete, Spain, 2006
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, Spain, 08025
Hospital Universitario de Burgos. Servicio de Neurología
Burgos, Spain, 09006
Hospital la Magdalena; Servicio de Neurologia
Castellon, Spain, 12004
Hospital Universitario Reina Sofia; Servicio de Neurologia
Cordoba, Spain, 14011
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, Spain, 28034
Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla
Salamanca, Spain, 37005
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla, Spain, 41009
Sweden
Skånes Universitetssjukhus Malmö, Minneskliniken
Malmö, Sweden, 211 46
Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry
Mölndal, Sweden, 431 41
Taiwan
Changhua Christian Hospital; Neurology
Changhua County, Taiwan, 500
Kaohsiung Medical University Hospital; Neurology
Kaohsiung, Taiwan, 807
Taipei Medical University - Shuang Ho Hospital - Neurology
New Taipei City, Taiwan, 23561
National Taiwan University Hospital; Neurology
Taipei, Taiwan, 100
Chang Gung Memorial Foundation - Linkou - Neurology
Taoyuan, Taiwan, 333
Turkey
Hacettepe University Medical Faculty; Neurology
Ankara, Turkey, 06100
Istanbul University Istanbul School of Medicine; Neurology
Istanbul, Turkey, 34093
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, Turkey, 55139
United Kingdom
The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre
Cheltenham, United Kingdom, GL53 9DZ
Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
Chertsey, United Kingdom, KT16 0AE
Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit
Crowborough, United Kingdom, TN6 1HB
Ninewells Hospital
Dundee, United Kingdom, DD12 9SY
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Queen Elizabeth University Hospital; Clinical Research Facility
Glasgow, United Kingdom, G51 4TF
RE:Cognition Health
London, United Kingdom, W1G 9RU
Charing Cross Hospital; Imperial Memory Unit, Level 10 West
London, United Kingdom, W6 8RF
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
University Southampton NHS Foundation Trust; Wessex Neurologica Centre
Southampton, United Kingdom, SO166YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03114657    
Other Study ID Numbers: BN29553
2016-003288-20 ( EudraCT Number )
First Posted: April 14, 2017    Key Record Dates
Results First Posted: June 12, 2020
Last Update Posted: July 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders