A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ)

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ClinicalTrials.gov Identifier: NCT02783573

Recruitment Status : Terminated (An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.)

First Posted : May 26, 2016

Results First Posted : August 6, 2019

Last Update Posted : December 3, 2019

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

AstraZeneca

Study Description

Brief Summary:

The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1722 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia
Actual Study Start Date :	July 1, 2016
Actual Primary Completion Date :	September 28, 2018
Actual Study Completion Date :	September 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lanabecestat 20 milligrams (mg) Participants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.	Drug: Lanabecestat Administered orally Other Names: LY3314814 AZD3293
Experimental: Lanabecestat 50 mg Participants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.	Drug: Lanabecestat Administered orally Other Names: LY3314814 AZD3293
Experimental: Placebo/ Lanabecestat 20 mg Placebo given orally once daily for 78 weeks and then 20 mg of lanabecestat given orally once daily until week 156.	Drug: Lanabecestat Administered orally Other Names: LY3314814 AZD3293 Drug: Placebo Administered orally
Experimental: Placebo/ Lanabecestat 50 mg Placebo given orally once daily for 78 weeks and then 50 mg of lanabecestat given orally once daily until week 156.	Drug: Lanabecestat Administered orally Other Names: LY3314814 AZD3293 Drug: Placebo Administered orally

Outcome Measures

Primary Outcome Measures :

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score [ Time Frame: Baseline, Week 78 ]
ADAS-Cog13 (13-item version of ADAS Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, acetylcholinesterase Inhibitor (AChEI) use at baseline, pooled site, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.

Secondary Outcome Measures :

Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL) [ Time Frame: Baseline, Week 78 ]
The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.
Change From Baseline in Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline, Week 78 ]
FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now=1; never did [the activity] but could do now=0; normal=0; has difficulty but does by self=1; requires assistance=2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline FAQ total score, by-visit interaction and age at baseline.
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, Week 78 ]
The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.
Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 78 ]
The CDR-SB is a rater administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.
Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage [ Time Frame: From Loss of 1 Global Stage through Week 78 ]
The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).
Change From Baseline in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 78 ]
The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.
Change From Baseline on the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 78 ]
The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.
Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42 [ Time Frame: Baseline, Week 71 ]
Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.
Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40 [ Time Frame: Baseline, Week 71 ]
Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.
Change From Baseline in CSF Biomarker Total Tau [ Time Frame: Baseline, Week 71 ]
Cerebrospinal fluid samples were collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.
Change From Baseline in CSF Biomarker Phosphorylated Tau [ Time Frame: Baseline, Week 71 ]
Cerebrospinal fluid samples are collected for analysis of concentration of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.
Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, Week 78 ]
Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by using ANCOVA methodology with terms for treatment, baseline biomarker and age at baseline.
Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan [ Time Frame: Baseline, Week 78 ]
Florbetapir perfusion evaluated the regional cerebral blood flow (rCBF) as a biomarker of brain function and was performed at the same time as the amyloid florbetapir PET. Cerebral perfusion, especially in temporal and parietal areas, is reduced in AD and this pattern of hypoperfusion closely mirrors the hypometabolism pattern observed using FDG PET. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA with LOCF (last observation carried forward) and with factors for treatment, baseline biomarker and age at baseline.
Change From Baseline in Whole Brain Volume [ Time Frame: Baseline, Week 78 ]
Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on brain atrophy/whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline volumetric magnetic resonance imaging (vMRI), intracranial volume and age at baseline.
Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat [ Time Frame: Predose, Week 4, 7, 19, 39, 45 and Week 71 post dose ]
The apparent oral clearance of lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.
Population PK: Central Volume of Distribution of Lanabecestat [ Time Frame: Predose, Week 4, 7, 19, 39, 45 and week 71 post dose ]
The central volume of distribution for lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.

Eligibility Criteria

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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:

Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
MMSE score of 20 to 26 inclusive at screening visit.
For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
Evidence of amyloid pathology.
The participant must have a reliable study partner with whom he/she cohabits or has regular contact.

Exclusion Criteria:

Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
Congenital QT prolongation.
Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at screening (as determined at the investigational site).
History of malignant cancer within the last 5 years.
History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Contacts and Locations

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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): NCT02783573

Locations

Show 262 study locations

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United States, Arizona
Xenoscience
Phoenix, Arizona, United States, 85004
St Josephs Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Four Peaks Neurology
Scottsdale, Arizona, United States, 85258
Arizona Neurology
Scottsdale, Arizona, United States, 85260
Center for Neurosciences
Tucson, Arizona, United States, 85718
United States, Arkansas
NEA Baptist Clinical
Jonesboro, Arkansas, United States, 72401
United States, California
The Research Center of Southern California
Carlsbad, California, United States, 92011
WCCT Global
Costa Mesa, California, United States, 92626
Neuro-Pain Medical Center
Fresno, California, United States, 93710
Neurology Center of North Orange County
Fullerton, California, United States, 92835
Pacific Neuroscience Medical Group
Oxnard, California, United States, 93030
California Research Foundation
San Diego, California, United States, 92103-6204
Pacific Research Network Inc
San Diego, California, United States, 92103
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Care Access Research
Santa Clarita, California, United States, 91321
California Neuroscience Research
Sherman Oaks, California, United States, 91403
Care Access Research
Valencia, California, United States, 91355
United States, Connecticut
Associated Neurologists, PC - Danbury
Danbury, Connecticut, United States, 06810
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Research Center for Clinical Studies, Inc
Norwalk, Connecticut, United States, 06851
United States, Florida
JEM Research Institute
Atlantis, Florida, United States, 33462
Morton Plant Hospital
Clearwater, Florida, United States, 33755
Brain Matters Research
Delray Beach, Florida, United States, 33445
Cohen Medical Associates P.A.
Delray Beach, Florida, United States, 33446
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Indago Research & Health Center, Inc.
Hialeah, Florida, United States, 33012
Infinity Clinical Research, LLC
Hollywood, Florida, United States, 33021
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Gregory A. Kirk MD LLC
Merritt Island, Florida, United States, 32955
University of Miami
Miami, Florida, United States, 33136
Allied Biomedical Research Institute, Inc.
Miami, Florida, United States, 33155
Compass Research
Orlando, Florida, United States, 32806
Quantum Laboratories
Pompano Beach, Florida, United States, 33064
Charlotte Neurological Services
Port Charlotte, Florida, United States, 33980
Intercoastal Medical Group
Sarasota, Florida, United States, 34239
Axiom Research
Tampa, Florida, United States, 33609
University of South Florida
Tampa, Florida, United States, 33616
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Atlanta Center of Medical Research
Atlanta, Georgia, United States, 30331
Georgia Regents University
Augusta, Georgia, United States, 30912
Medical Research Health and Education Foundation, Inc
Columbus, Georgia, United States, 31909
United States, Hawaii
Hawaii Medical Center
Honolulu, Hawaii, United States, 96817
United States, Idaho
Advanced Clinical Research LLC
Meridian, Idaho, United States, 83642
United States, Indiana
American Health Network
Avon, Indiana, United States, 46123
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, United States, 46256
American Health Network
Muncie, Indiana, United States, 47304
United States, Kansas
University of Kansas Hospital
Fairway, Kansas, United States, 66160
Cotton O'Neil Clinic
Topeka, Kansas, United States, 66606
Via Christi Research, Inc.
Wichita, Kansas, United States, 67214
United States, Kentucky
Baptist Health Medical Group
Lexington, Kentucky, United States, 40503
Associates in Neurology, PSC
Lexington, Kentucky, United States, 40513
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Neurology
Scarborough, Maine, United States, 04074
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Donald S Marks
Plymouth, Massachusetts, United States, 02360-4843
Alzheimers Disease Center
Winchester, Massachusetts, United States, 01890
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Clinical Research Professionals
Saint Louis, Missouri, United States, 63141
United States, Nevada
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89113
United States, New Jersey
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States, 08755
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, United States, 07764
United States, New York
New York University Medical Center
New York, New York, United States, 10016
United States, North Carolina
Behavioral Health Center Research
Charlotte, North Carolina, United States, 28211
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
Wake Forest Baptist Univ CAR
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Rapid Medical Research Inc
Cleveland, Ohio, United States, 44122
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Insight Clinical Trials
Shaker Heights, Ohio, United States, 44122
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
The Corvallis Clinic P.C.
Corvallis, Oregon, United States, 97330
Summit Research Network Inc
Portland, Oregon, United States, 97210
United States, Pennsylvania
Clinical Trial Center, LLC, Psychiatry
Jenkintown, Pennsylvania, United States, 19046
Pearl Clinical Research Inc.
Norristown, Pennsylvania, United States, 19401
United States, Rhode Island
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Radiant Research
Greer, South Carolina, United States, 29650
Coastal Neurology PA
Port Royal, South Carolina, United States, 29935
United States, Tennessee
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States, 37660
United States, Texas
Univ of North Texas Health Science Center
Fort Worth, Texas, United States, 76107
Texas Medical Research Associates, L.L.C.
San Antonio, Texas, United States, 78238
United States, Utah
Ericksen Research and Development
Clinton, Utah, United States, 84015
United States, Wisconsin
SSM Health Dean Medical Group
Madison, Wisconsin, United States, 53715
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 426
Canada, British Columbia
The Medical Arts Health Research Group
West Vancouver, British Columbia, Canada, V7T223
Canada, Nova Scotia
True North Clinical Research Halifax, LLC
Halifax, Nova Scotia, Canada, B3S1M7
Canada, Ontario
Bruyere Continuing Care
Ottawa, Ontario, Canada, K1N 5C8
Kawartha Regional Memory Clinic
Peterborough, Ontario, Canada, K9H2P4
Toronto Memory Program
Toronto, Ontario, Canada, M3B2S7
Toronto Sunnybrook Regional Cancer Center
Toronto, Ontario, Canada, M4N 3M5
Canada, Qubec
CSSS-Institut Universitaire Gériatric de Sherbrooke
Sherbrooke, Qubec, Canada, J1J3H5
Canada, Quebec
Recherches Neuro-Hippocampe Inc
Gatineau, Quebec, Canada, J8T 8J1
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, Canada, J1J 2G2
Douglas Hospital and Research Centre
Verdun, Quebec, Canada, H4H 1R3
China, Beijing
Xuanwu Hospital-Capital Medical University
Beijing, Beijing, China, 100053
Beijing 301 Hospital
Beijing, Beijing, China, 100853
China, Guangdong
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
China, Hebei
Tangshan Worker Hospital
Tangshan, Hebei, China, 063000
China, Jiangsu
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
Nanjing, Jiangsu, China, 210008
Zhongda Hospital-Southeast University
Nanjing, Jiangsu, China, 210009
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001
China, Shandong
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266071
China, Shanghai
Shanghai Tongji Hospital(CCBR site)
Shanghai, Shanghai, China, 200065
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China, Zhejiang
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310003
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325035
China
Shanghai Huashan Hospital Affil to Fu Dan University
Shanghai, China, 200040
Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia, 65691
Neurohk s.r.o.
Chocen, Czechia, 565 01
Neuropsychiatrie s.r.o
Hradec Kralove, Czechia, 50009
Brain-Soultherapy s.r.o
Kladno, Czechia, 27201
A-Shine s.r.o.
Plzen, Czechia, 31200
Clintrial, s.r.o.
Praha 10, Czechia, 100 00
Neuropsychiatrie s.r.o
Praha 6, Czechia, 160 00
Medical Services Prague s.r.o.
Praha 6, Czechia, 16000
Axon Clinical, s.r.o.
Praha 8, Czechia, 182 00
Denmark
CCBR-Alborg-DK
Aalborg, Denmark, 9100
Center For Clinical and Basic Research
Ballerup, Denmark, 2750
Rigshospitalet
Copenhagen, Denmark, 2100 CPH
Center for Clinical and Basic Research -CCBR
Vejle, Denmark, 7100
France
Institut Claude Pompidou - CMRR
Nice, Alpes Maritimes, France, 06100
CHU Rennes/Hopital Sud
Rennes Cedex, Ille Et Vilaine, France, 35064
CHU Saint Etienne - Hopital Nord
Saint Priest en Jarez, Loire, France, 42270
Chu De Nancy Hop D'Adultes De Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
CHU d'Amiens-Picardie Hopital Sud
Amiens Cedex 1, France, 80054
CHU de Caen Hopital Cote de Nacre
Caen Cedex, France, 14033
APHM Hôpital de la Timone
Marseille, France, 13385
Hôpital de la Pitié-Salpêtrière
Paris, France, 75013
CHU Strasbourg Hôpital de Hautepierre
Strasbourg Cedex, France, 67098
Chu de Toulouse Hopital de La Grave
Toulouse Cedex, France, 31059
Germany
Praxis Dr. Erich Scholz
Böblingen, Baden-Württemberg, Germany, 71034
ISPG - Institut für Studien zur psychischen Gesundheit
Mannheim, Baden-Württemberg, Germany, 68165
Praxis für Neurologie und Psychiatrie Dr. med. Roth
Ostfildern, Baden-Württemberg, Germany, 73760
Neurozentrum Sophienstraße
Stuttgart, Baden-Württemberg, Germany, 70178
Klinikum der Universität München
München, Bayern, Germany, 81377
Klinikum Rechts der Isar der TU München
München, Bayern, Germany, 81675
Neuropraxis München Süd
Unterhaching, Bayern, Germany, 82008
Diakoniekrankenhaus Henriettenstiftung Hannover
Hannover, Niedersachsen, Germany, 30559
MVZ LiO Berlin
Berlin, Germany, 12209
Italy
Policlinico Univ. Agostino Gemelli
Roma, Lazio, Italy, 00168
Spedali Civili - Universita degli Studi
Brescia, Italy, 25123
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy, 50134
Ente Ospedaliero Ospedali Galliera
Genova, Italy, 16128
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
SDN - Istituto di Ricerca Diagnostica e Nucleare
Napoli, Italy, 80143
Azienda Ospedaliera - Universitaria Pisana
Pisa, Italy, 56126
IRCCS Santa Lucia
Roma, Italy, 00179
Universita La Sapienza
Roma, Italy, 00185
Azienda Ospedaliera Citta della Salute della Scienza Torino
Torino, Italy, 10126
Japan
Shinwakai Yachiyo Hospital
Anjo-shi, Aichi-Ken, Japan, 446-8510
Nagoya Ekisaikai Hospital
Nagoya-shi, Aichi-Ken, Japan, 454-8502
Kojunkai Daido Hospital
Nagoya-Shi, Aichi-Ken, Japan, 457-8511
Inage Neurology and Memory Clinic
Chiba-shi, Chiba-Ken, Japan, 263-0043
Ehime University Hospital
Toon-Shi, Ehime-Ken, Japan, 791-0295
Jisenkai Nanko Psychiatric Institute
Shirakawa-shi, Fukushima-Ken, Japan, 961-0021
Takeda General Hospital
Aizu-Wakamatsu, Fukushima, Japan, 965-8585
Koseikai Kusatsu Hospital
Hiroshima-shi, Hiroshima-Ken, Japan, 733-0864
NHO Hiroshima-Nishi Medical Center
Otaki-Shi, Hiroshima-Ken, Japan, 739-0696
Yokohama Hospital
Yokohama, Kanagawa, Japan, 221-0801
Koseikai Takeda Hospital
Kyoto-Shi, Kyoto-Fu, Japan, 600-8558
Uji Takeda Hospital
Uji-Shi, Kyoto-Fu, Japan, 611-0021
JADECOM Nara City Hospital
Nara-Shi, Nara-Ken, Japan, 630-8305
Nara Medical University Hospital
Kashihara, Nara, Japan, 634-8522
Oita University Hospital
Yufu-shi, Oita-Ken, Japan, 879-5593
Katayama Medical Clinic
Kurashiki-shi, Okayama-Ken, Japan, 710-0813
Himuro Neurology Clinic
Osaka-Shi, Osaka-Fu, Japan, 534-0021
Kotobukikai Tominaga Clinic
Osaka-shi, Osaka-Fu, Japan, 556-0015
Kousaiin Hospital
Suita-shi, Osaka-Fu, Japan, 565-0874
NHO Hizen Psychiatric Center
Kanzaki-gun, Saga-Ken, Japan, 842-0192
Shimizu Hospital
Shizuoka-shi, Shizuoka, Japan, 424-8636
Keikokai P-One Clinic
Hachioji-shi, Tokyo-To, Japan, 192-0071
Memory Clinic Ochanomizu
Bunkyo-ku, Tokyo, Japan, 113-0034
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Musashino Red Cross Hospital
Musashino, Tokyo, Japan, 180-8610
JOHAS Sanin Rosai Hospital
Yonago-shi, Tottori-Ken, Japan, 683-8605
Aomori Prefectural Centeral Hospital
Aomori, Japan, 030-8553
Ikeuchi Psycho Induced Internal Clinic
Kobe-shi, Japan, 655-0037
Yuge Hospital
Kumamoto, Japan, 861-8002
NHO Niigata Hospital
Niigata, Japan, 945-8585
NHO Hokkaido Medical Center
Sapporo-shi, Japan, 063-0005
Korea, Republic of
Dong-A University Medical Center
Busan, Busan Gwang'yeogsi, Korea, Republic of, 49201
The Catholic University of Korea-Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
Myongji Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Inha University Hospital
Incheon, Korea, Republic of, 22332
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Hanyang University Medical Center
Seoul, Korea, Republic of, 04763
Konkuk University Hospital
Seoul, Korea, Republic of, 05030
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Mexico
Hospital Universitario de Saltillo
Saltillo, Coahuila, Mexico, 25000
Mexico Centre for Clinical Research SA de CV
Mexico City, Distrito Federal, Mexico, 03100
Clinical Research Institute S C
Tlalnepantla, Edo De Mex, Mexico, 54055
Hospital Univ. Jose Eleuterio Gonzalez
Monterrey, N.l., Mexico, 64460
Instituto de Informacion en Salud Mental (INFOSAM)
Monterrey, NL, Mexico, 64710
Accelerium Clinical Research
Monterrey, Nuevo Leon, Mexico, 64000
Centro de Estudios Clinicos y Esp Medicas SC
Monterrey, Nuevo Leon, Mexico, 64620
Avix Investigación Clínica, S.C
Monterrey, Nuevo León, Mexico, 64710
Netherlands
Emotional Brain B.V.
Almere, Netherlands, 1311 RL
Brain Research Center
Amsterdam, Netherlands, 1081 GM
Amphia Ziekenhuis
Breda, Netherlands, 4818 CK
EB Utrecht
Utrecht, Netherlands, 3511 NH
Isala Klinieken
Zwolle, Netherlands, 8025 AB
Poland
NZOZ Wroclawskie Centrum Alzheimerowskie
Wroclaw, Dolnoslaskie, Poland, 53 139
Podlaskie Centrum Psychogeriatrii
Białystok, Podlaskie, Poland, 15-732
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomorskie, Poland, 80-952
NZOZ Mach-Med
Chorzow, Poland, 41-506
Klinika Neurologii Neuro-Care
Katowice, Poland, 40749
Globe Badania Kliniczne SP Z O.O.
Klodzko, Poland, 57-300
Prywatny Gabinet Lekarski U.Chyrchel
Lublin, Poland, 20-582
Centrum Medyczne Medyk
Rzeszow, Poland, 35-055
Euromedis Sp. z o.o.
Szczecin, Poland, 70-111
Clinsante Centrum Medyczne
Torun, Poland, 87-100
Centrum Medyczne
Warszawa, Poland, 01-697
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED
Warszawa, Poland, 01-737
Portugal
Hospital Fernando Fonseca
Amadora, Portugal, 2700-351
Hospital de Braga
Braga, Portugal, 4710-243
Hospitals da Universidade de Coimbra
Coimbra, Portugal, 3000-075
Russian Federation
SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst
Kazan, Russian Federation, 420064
SIH Kemerovo Regional Clinical Hosptial
Kemerovo, Russian Federation, 650066
FSBIH Siberian Clinical Center of FMBA
Krasnoyarsk, Russian Federation, 660049
LLC City Neurological Centre Sibneuromed
Novosibirsk, Russian Federation, 630091
Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630091
Ultramed
Omsk, Russian Federation, 644024
LLC Treatment and Rehabilitation
Rostov-on-Don, Russian Federation, 344010
RSBIH Smolensk Regional Clinical Hospital
Smolensk, Russian Federation, 214018
Bekhterev Psyconeurological Institute
St. Petersburg, Russian Federation, 192019
Central Medical Sanitary Hospital #122
St. Petersburg, Russian Federation, 194291
Regional State Institution of Healthcare Tomsk Clinica Psych
Tomsk, Russian Federation, 634014
Spain
Hospital Cardiovascular San Vicente
San Vicente del Raspeig, Alicante, Spain, 03690
Hospital General de Catalunya
Sant Cugat del Valles, Barcelona, Spain, 08190
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital Virgen Del Puerto
Plasencia, Caceres, Spain, 10600
Policlinica Guipuzcoa
Donostia, Guipuzcoa, Spain, 20009
Hospital Ntra Sra Perpetuo Socorro
Albacete, Spain, 02006
Hospital del Mar
Barcelona, Spain, 08003
Fundacion ACE-Institut Catala de Neurociences Aplicades
Barcelona, Spain, 08028
Hospital Universitario La Fe de Valencia
Valencia, Spain, 46026
Taiwan
Cardinal Tien Hospital
Sindian City, Taipei County, Taiwan, 23148
National Taiwan University Hospital
Douliu, Yunlin County, Taiwan, 640
Changhua Christian Hospital
Changhua, Taiwan, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung, Taiwan, 83301
Taipei Medical University- Shuang Ho Hospital
New Taipei, Taiwan, 23561
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Chang Gung Memorial Hospital - Linkou
Taoyuan City, Taiwan, 33305
United Kingdom
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom, EX2 5DW
Re-Cognition Health Ltd
Plymouth, Devon, United Kingdom, PL6 8BT
Charlton Lane Hospital
Cheltenham, Gloucestershire, United Kingdom, GL53 9DZ
Re-Cognition Health Ltd
Guildford, Surrey, United Kingdom, GU2 7YD
Murray Royal Hospital
Perth, Tayside Region, United Kingdom, PH2 7BH
Victoria Centre
Swindon, Wiltshire, United Kingdom, SN3 6BW
Glasgow Memory Clinic
Glasgow, United Kingdom, G20 0XA
Re-Cognition Health Ltd
London, United Kingdom, W1G9JF

Sponsors and Collaborators

AstraZeneca

Eli Lilly and Company

Investigators

Layout table for investigator information

Study Director:	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company

Study Documents (Full-Text)

Documents provided by AstraZeneca:

Study Protocol [PDF] February 5, 2016

Statistical Analysis Plan [PDF] September 17, 2018

More Information

Additional Information:

Click here for more information about this study: A Study of LY3314814 in Participants With Mild Alzheimer's Disease Dementia (DAYBREAK-ALZ) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

CSP

SAP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988. Erratum in: JAMA Neurol. 2020 Sep 1;77(9):1179.

Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjäll S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053.

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT02783573
Other Study ID Numbers:	16024 I8D-MC-AZET ( Other Identifier: Eli Lilly and Company ) 2015-005625-39 ( EudraCT Number )
First Posted:	May 26, 2016 Key Record Dates
Results First Posted:	August 6, 2019
Last Update Posted:	December 3, 2019
Last Verified:	October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
Time Frame:	Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria:	A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL:	https://www.clinicalstudydatarequest.com/

Keywords provided by AstraZeneca:


dementia brain diseases neurodegenerative diseases central nervous system diseases nervous system diseases	mental disorders delirium, dementia, amnestic, cognitive tauopathies memory amyloid

Additional relevant MeSH terms:

Layout table for MeSH terms

Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

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