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Trial record 3 of 4 for:    ABBV-8E12

A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT02880956
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ABBV-8E12 Drug: placebo for ABBV-8E12 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease
Actual Study Start Date : October 17, 2016
Estimated Primary Completion Date : December 16, 2020
Estimated Study Completion Date : April 7, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 2
Dose 2 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion

Experimental: Group 3
Dose 3 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion

Experimental: Group 1
Dose 1 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion

Placebo Comparator: Group 4
Placebo for ABBV-8E12
Drug: placebo for ABBV-8E12
placebo solution for IV infusion




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 112 weeks ]
  2. Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Week 96 ]
    A scale used to quantify the severity of symptoms of dementia.


Secondary Outcome Measures :
  1. University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) [ Time Frame: 96 weeks ]
    A performance-based instrument which uses a series of tasks and role-play scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills).

  2. Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 96 weeks ]
  3. Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
  4. Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  5. Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  6. Mini-Mental State Examination (MMSE) [ Time Frame: 96 weeks ]
    A 30-point questionnaire that provides a quantitative measure of cognitive mental status in adults.

  7. 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients with Mild Cognitive Impairment (ADCS-MCI-ADL-24) [ Time Frame: 96 weeks ]
    A 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients.

  8. Functional Activities Questionnaire (FAQ) [ Time Frame: 96 weeks ]
    A questionnaire used to measure level of assistance (functional disability) needed for carrying out instrumental activities in daily living.

  9. Repeatable Battery for Assessment of Neuropsychological Status (RBANS) [ Time Frame: 96 weeks ]
    A standardized neurocognitive battery that measures cognitive decline or improvement across five neurocognitive domains.

  10. Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI). [ Time Frame: 96 weeks ]
    The instrument assesses the physician's global impression of change four major cognitive domains.

  11. Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) [ Time Frame: 96 weeks ]
    A scale that assesses the cognitive impairments most common in AD.

  12. Neuropsychiatry Inventory (NPI) [ Time Frame: 96 weeks ]
    Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias.



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:

    • Clinical Dementia Rating (CDR)-Global Score of 0.5
    • Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
    • Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower
  • Subject has a positive amyloid Positron Emission Tomography (PET) scan.
  • Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.
  • The subject has an identified, reliable, study partner (e.g., family member).
  • If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.

Exclusion Criteria:

  • Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture.
  • Subject has evidence of any other clinically significant neurological disorder other than Early AD.
  • In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days.
  • Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.

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): NCT02880956


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Hide Study Locations
Locations
United States, Arizona
Banner University MC Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Banner Sun Health Res Inst Recruiting
Sun City, Arizona, United States, 85351
United States, California
Irvine Clinical Research Recruiting
Irvine, California, United States, 92614
Ctipm @ Actri Not yet recruiting
La Jolla, California, United States, 92037
Ray Dolby Brain Health Center Recruiting
San Francisco, California, United States, 94113
Univ California, San Francisco Recruiting
San Francisco, California, United States, 94143-2204
United States, Florida
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Southwest Florida Neuropsych Recruiting
Fort Myers, Florida, United States, 33912
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Compass Research LLC Recruiting
Orlando, Florida, United States, 32806
University of South Florida Recruiting
Tampa, Florida, United States, 33606-3603
Compass Research, LLC Recruiting
The Villages, Florida, United States, 32162
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Atlanta Center for Medical Res Recruiting
Atlanta, Georgia, United States, 30331
NeuroStudies.net, LLC Recruiting
Decatur, Georgia, United States, 30033
United States, Illinois
Great Lakes Clinical Trials Recruiting
Chicago, Illinois, United States, 60640
Advocate Lutheran General Hosp Recruiting
Park Ridge, Illinois, United States, 60068
Southern IL Univ School of Med Recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center - Alzheimer's Disease Center Recruiting
Fairway, Kansas, United States, 66205
United States, Kentucky
Univ Kentucky Med Ctr Recruiting
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins Bayview Med Cnt Not yet recruiting
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Brighan and Women's Physicians Recruiting
Boston, Massachusetts, United States, 02115
United States, New Jersey
Princeton Medical Institute Recruiting
Princeton, New Jersey, United States, 08540
United States, New York
Scott Research Inc. Recruiting
Laurelton, New York, United States, 11413
North Shore University Hospital Recruiting
New Hyde Park, New York, United States, 11040
United States, North Carolina
Duke Univ Med Ctr Recruiting
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
Vanderbilt Univ Med Ctr Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Kerwin Research Center Recruiting
Dallas, Texas, United States, 75231-4316
Nantz National Alzheimer Ctr Recruiting
Houston, Texas, United States, 77030
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112-5500
United States, Virginia
Integrated Neurology Services Recruiting
Alexandria, Virginia, United States, 22310
Australia, New South Wales
St. Vincent's Hospital, Darlinghurst Recruiting
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Griffith University Recruiting
Southport, Queensland, Australia, 4222
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Australian Alzheimer's Res Fou Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Neurodegenerative Disorders Re Not yet recruiting
West Perth, Western Australia, Australia, 6005
Belgium
Cliniques Universitaires Saint Luc Recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
CHU de Liege Not yet recruiting
Liège, Liege, Belgium, 4000
UZ Leuven Recruiting
Leuven, Belgium, 3000
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6T 2A1
Canada, Ontario
Parkwood Institute Not yet recruiting
London, Ontario, Canada, N6C 5J1
Toronto Memory Program Recruiting
Toronto, Ontario, Canada, M3B 2S7
Denmark
Rigshospitalet, Memory Clinic Recruiting
Copenhagen Ø, Hovedstaden, Denmark, 2100
Finland
Ita-Suomen Yliopisto Recruiting
Kuopio, Finland, 70210
Clinical Research Services Tur Recruiting
Turku, Finland, 20520
Italy
AOU di Modena Recruiting
Modena, Emilia-Romagna, Italy, 41126
AP Romano Umberto I Not yet recruiting
Rome, Lazio, Italy, 00161
AO Univ Policlinico Agostino G Recruiting
Rome, Lazio, Italy, 00168
ASST Grande Ospedale Metropolitano Niguarda Not yet recruiting
Milano, Lombardia, Italy, 20162
IRCCS - San Giovanni di Recruiting
Brescia, Italy, 25125
Fondazione IRCCS Cà Granda Osp Recruiting
Milan, Italy, 20122
Azienda Ospedaliera di Perugia Recruiting
Perugia, Italy, 06126
Netherlands
Spaarne Gasthuis Not yet recruiting
Haarlem, Netherlands, 2035 RC
UMC Utrecht Not yet recruiting
Utrecht, Netherlands, 3584 CX
New Zealand
CGM Research Trust Recruiting
Burwood Christchurch, New Zealand, 8083
Spain
Fundacion CITA Alzheimer Recruiting
Donostia, Pais Vasco, Spain, 20009
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Fundacio ACE Recruiting
Barcelona, Spain, 8028
Hospital Clin Univ San Carlos Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario Doce de Recruiting
Madrid, Spain, 28041
Sweden
Sahlgrenska US Mölndal Not yet recruiting
Mölndal, Vastra Gotalands Lan, Sweden, 431 80
Karolinska University Hospital Not yet recruiting
Huddinge, Sweden, 141 86
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02880956     History of Changes
Other Study ID Numbers: M15-566
2016-001634-10 ( EudraCT Number )
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Early Alzheimer's Disease (AD)
Mild Cognitive Impairment (MCI)
Mild Alzheimer's Disease (AD)
Tau
Early dementia
Tauopathies
AD
Neurodegenerative diseases
Memory loss
Nervous system diseases

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders