An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease

NCT ID: NCT02245737

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 2218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-10-04

Brief Summary

The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo.

Detailed Description

Participants who meet other study entry requirements will be required to undergo either an amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid (CSF) sampling at screening to document presence of abnormal levels of brain and CSF amyloid for study inclusion. The study includes 2 sub-studies: the participants that undergo a PET scan at screening will be included in the PET-substudy, and participants who undergo a lumbar puncture at screening will be included in the CSF substudy until each of these substudies are completed.

Conditions

Alzheimer´s Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lanabecestat 20 milligrams (mg)

Lanabecestat 20 mg given orally once daily for 104 weeks.

Group Type: EXPERIMENTAL

Lanabecestat

Intervention Type: DRUG

Administered orally

Lanabecestat 50 mg

Lanabecestat 50 mg given orally once daily for 104 weeks.

Group Type: EXPERIMENTAL

Lanabecestat

Intervention Type: DRUG

Administered orally

Placebo

Placebo given orally once daily for 104 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Interventions

Lanabecestat

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY3314814; AZD3293

Eligibility Criteria

Inclusion Criteria

• Gradual and progressive change in the participant's memory function over more than 6 months, reported by participant and study partner
• Mini-Mental State Examination score of 20-30 inclusive at screening
• Objective impairment in memory as evaluated by memory test performed at screening
• For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD
• For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD

Exclusion Criteria

• Significant 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, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures
• History of clinically evident stroke, or multiple strokes based on history or imaging results
• History of clinically important carotid or vertebrobasilar stenosis or plaque
• History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
• Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or 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 assessments, or affect the participant´s ability to complete the study
• History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
• Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
• Congenital QT prolongation
• History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread
• Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Banner Alzheimer's Institute

Phoenix, Arizona, United States

St Josephs Hospital and Medical Center

Phoenix, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Territory Neurology & Research Institute

Tucson, Arizona, United States

Positron Research International

Fremont, California, United States

Alliance Research Centers

Laguna Hills, California, United States

Senior Clinical Trials, Inc.

Laguna Hills, California, United States

Collaborative Neuroscience Network - CNS

Long Beach, California, United States

Pacific Research Network Inc

San Diego, California, United States

San Francisco Clinical Research Center

San Francisco, California, United States

Mile High Research Center

Denver, Colorado, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Brain Matters Research

Delray Beach, Florida, United States

Direct Helpers Medical Center

Hialeah, Florida, United States

Berma Research

Hialeah, Florida, United States

Galiz Research

Hialeah, Florida, United States

MaxBlue Institute

Hialeah, Florida, United States

Alzheimer's Research and Treatment Center

Lake Worth, Florida, United States

Miami Jewish Health Systems

Miami, Florida, United States

Medical Research Center

Miami, Florida, United States

Allied Biomedical Research Institute, Inc.

Miami, Florida, United States

Advance Medical Research Institute

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

JDH Medical Group, LLC

Miami, Florida, United States

Compass Research

Orlando, Florida, United States

IMIC, Inc.

Palmetto Bay, Florida, United States

Roskamp Institute

Sarasota, Florida, United States

Suncoast Neuroscience Associates

St. Petersburg, Florida, United States

Infinity Clinical Research, LLC

Sunrise, Florida, United States

Stedman Clinical Trials

Tampa, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

Compass Research

The Villages, Florida, United States

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, United States

The Multiple Sclerosis Center of Atlanta

Atlanta, Georgia, United States

Atlanta Center of Medical Research

Atlanta, Georgia, United States

Carman Research

Smyrna, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Community Clinical Research Center

Anderson, Indiana, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

ActivMed Practices & Research, Inc

Methuen, Massachusetts, United States

Boston Center for Memory

Newton, Massachusetts, United States

Springfield Neurology Associates

Springfield, Massachusetts, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Millennium Psychiatric Associates, LLV

St Louis, Missouri, United States

St. Louis Clinical Trials, LC

St Louis, Missouri, United States

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, United States

AdvanceMed Research

Lawrenceville, New Jersey, United States

Alzheimer's Research Company

Paterson, New Jersey, United States

The Cognitive and Research Center of NJ

Springfield, New Jersey, United States

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Neurology Specialists of Monmouth County

West Long Branch, New Jersey, United States

Integrative Clinical Trials, LLC

Brooklyn, New York, United States

SPRI Clinical Trials, LLC.

Brooklyn, New York, United States

Alzheimer's Disease and Memory Disorders Center

Buffalo, New York, United States

Empire Neurology, PC

Latham, New York, United States

Clinilabs, Inc (New York)

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Alzheimer's Memory Center

Charlotte, North Carolina, United States

Valley Medical Primary Care

Centerville, Ohio, United States

Christ Hospital

Cincinnati, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

The Corvallis Clinic P.C.

Corvallis, Oregon, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

Roper St. Francis Healthcare

Charleston, South Carolina, United States

Radiant Research

Greer, South Carolina, United States

Quillen College of Medicine, East TN State University

Johnson City, Tennessee, United States

Senior Adults Specialty Research Inc

Austin, Texas, United States

Texas Health Physicians Group

Dallas, Texas, United States

Medical Group of Texas

Fort Worth, Texas, United States

University of Texas Health Services Center - Houston

Houston, Texas, United States

University of Utah School of Medicine

Salt Lake City, Utah, United States

The Memory Clinic

Bennington, Vermont, United States

Southern Neurology

Kogarah, New South Wales, Australia

Griffith University

Gold Coast, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Delmont Private Hospital

Glen Iris, Victoria, Australia

Heidelberg Repatriation Hospital

Heidelberg, Victoria, Australia

The Florey Institute of Neuroscience and Mental Health

Parkville, Victoria, Australia

Australian Alzheimer's Research Foundation

Nedlands, Western Australia, Australia

Neuro Trials Victoria Pty Ltd

Noble Park, , Australia

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

Hopital Universitaire Brugmann Brussel

Brussels, , Belgium

Hospital Universitaire Erasme Brussel

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Heilig Hartziekenhuis

Roeselare, , Belgium

The Medical Arts Health Research Group

Kamloops, British Columbia, Canada

Okanagan Clinical Trials

Kelowna, British Columbia, Canada

University of British Columbia

Vancouver, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

True North Clinical Research Halifax, LLC

Halifax, Nova Scotia, Canada

Bruyere Continuing Care

Ottawa, Ontario, Canada

Kawartha Regional Memory Clinic

Peterborough, Ontario, Canada

Toronto Memory Program

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

CSSS-Institut Universitaire Gériatric de Sherbrooke

Sherbrooke, Qubec, Canada

Clinique de la Memoire de l'Outaouais

Gatineau, Quebec, Canada

NeuroSearch Developements

Greenfield Park, Quebec, Canada

Hopital Maisonneure-Rosemount

Montreal, Quebec, Canada

Hopital de L'Enfant Jesus

Québec, Quebec, Canada

Q&T Research Sherbrooke Inc

Sherbrooke, Quebec, Canada

CHU de Toulouse Hopital Purpan

Toulouse, Cedex 9, France

Hopital Neuro Pierre Wertheimer

Bron, , France

CHU Dijonon

Dijon, , France

CHRU Lille - Hopital Roger Salengro

Lille, , France

CHU Hopital de la Timone

Marseille, , France

Chu de Nantes Hopital Laennec

Nantes, , France

Hopital Broca

Paris, , France

Hopital de la Pitie Salpetriere

Paris, , France

Hopital Lariboisière

Paris, , France

CHU de Toulouse

Toulouse, , France

Hopital des Charpennes

Villeurbanne, , France

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Studien und Gedächtniszentrum München

München, Bavaria, Germany

Klinikum Rechts der Isar der TU München

München, Bavaria, Germany

Institut fur Psychogerontologie

Nuremberg, Bavaria, Germany

Neurozentrum Prien

Prien am Chiemsee, Bavaria, Germany

Institut für Neuropsychiatrie INP3

Wenzenbach, Bavaria, Germany

Studienzentrum Nord-West

Westerstede, Lower Saxony, Germany

Praxis Dr. Lauter

Bochum, North Rhine-Westphalia, Germany

St Josef-Hospital Bochum

Bochum, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Neurologische Praxis Siegen

Siegen, North Rhine-Westphalia, Germany

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

Pharmakologisches Studienzentrum Chemnitz

Mittweida, Saxony, Germany

Martin-Luther-Universität Halle-Wittenberg

Halle, Saxony-Anhalt, Germany

Universitätsklinikum Otto-von-Guericke-Universität

Magdeburg, Saxony-Anhalt, Germany

Arztpraxis Dr. Christian Oehlwein

Gera, Thuringia, Germany

Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz

Berlin, , Germany

Charité Universitätsmedizin Berlin

Berlin, , Germany

Charité Universitätsmedizin Berlin

Berlin, , Germany

PTE KK Pszichiatriai es Pszichoterapias Klinika

Pécs, Baranya, Hungary

Semmelweis Medical University

Budapest, , Hungary

Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet

Budapest, , Hungary

Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

Debrecen, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Univerisity of Szeged

Szeged, , Hungary

Ospedale Degli Infermi ASR USSL 12

Ponderano, Biella, Italy

Azienda Ospedaliera San Gerardo

Monza, Milano, Italy

Fondazione San Raffaele Giglio di Cefalu

Cefalù, Palermo, Italy

Universita Di Pisa

Pisa, PI, Italy

Università Politecnica delle Marche Torrette

Ancona, , Italy

IRCCS San Giovanni di Dio Fatebenefratelli

Brescia, , Italy

Fondazione Universitaria degli Studi G D'Annunzio

Chieti, , Italy

Ente Ospedaliero Ospedali Galliera

Genova, , Italy

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico

Milan, , Italy

Nuovo Ospedale Civile Sant'Agostino Estense

Modena, , Italy

Policlinico Univ. Agostino Gemelli

Roma, , Italy

Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

Roma, , Italy

Ospedale San Giovanni Calibita Fatebenefratelli

Roma, , Italy

Policlinico Ospedale S. Andrea

Roma, , Italy

Azienda Ospedaliera Citta della Salute della Scienza Torino

Torino, , Italy

National Institute for Longevity Sciences NCGG

Ōbu, Aichi-ken, Japan

National Chiba-East-Hospital

Chuo-ku, Chiba, Japan

National Hospital Organization Asahikawa Medical Center

Asahikawa, Hokkaido, Japan

Tsukuba University Hospital

Tsukuba, Ibaraki, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Nihon Kokan Hospital

Kawasaki, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Rakuwakai Otowarehabilitation Hospital

Kyoto, Kyoto, Japan

Ina Central Hospital

Ina, Nagano, Japan

Matsumoto Medical Center

Matsumoto, Nagano, Japan

Katayama Medical Clinic

Kurashiki, Okayama-ken, Japan

Shiroma Clinic

Urasoe, Okinawa, Japan

Koshokai aino hospital

Ibaraki, Osaka, Japan

Sakaguchi Clinic

Sakai, Osaka, Japan

National Sanatorium Toneyama Hospital

Toyonaka, Osaka, Japan

Saitama Medical University Hospital

Iruma-Gun, Saitama, Japan

Nippon Medical School Hospital

Bunkyo-Ku, Tokyo, Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Nozomi Memory Clinic

Mitaka-shi, Tokyo, Japan

Sangenjaya Nakamura Mental Clinic

Setagaya City, Tokyo, Japan

Kanauchi Medical Clinic

Shinjuku-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Memory Clinic Ochanomizu

Tsukuba, Tokyo, Japan

National Sanatorium Hokuriku Hospital

Nanto, Toyama, Japan

Fukuoka University Hospital

Fukuoka, , Japan

Kyoto University Hospital

Kyoto, , Japan

Kyoto Minami Hospital

Kyoto, , Japan

Utano Hospital

Kyoto, , Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Osaka, , Japan

NZOZ Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship, Poland

Medycyna Milorzab

Lodz, Lódzkie, Poland

Podlaskie Centrum Psychogeriatrii

Bialystok, Podlaskie Voivodeship, Poland

NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.

Bydgoszcz, , Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska

Katowice, , Poland

Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala

Katowice, , Poland

Centrum Zdrowia Psychicznego

Kielce, , Poland

Centrum Neurologii Klinicznej

Krakow, , Poland

NZOZ Neuromed M. I M. Nastaj sp. P.

Lublin, , Poland

Instytut Medycyny Wsi

Lublin, , Poland

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Siemianowice Śląskie, , Poland

Centrum Medyczne

Warsaw, , Poland

Centralny Szpital Kliniczny MSW

Warsaw, , Poland

Santa Cruz Behavioral PSC

Bayamón, PR, Puerto Rico

Instituto de Neurologia Dra. Ivonne Fraga

San Juan, PR, Puerto Rico

Ivonne Z. Jimenez-Velazquez, MD

Carolina, , Puerto Rico

Michel A. Woodbury-Farina, MD.

San Juan, , Puerto Rico

SC Med Life SA

Bucharest, , Romania

SC Centrul Medical Sana SRL

Bucharest, , Romania

Policlinica CCBR S.R.L.

Bucharest, , Romania

SC Med Life SA

Timișoara, , Romania

Dong-A University Medical Center

Seogu, Busan, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Geonggi-do, South Korea

The Catholic University of Korea-Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

Hanyang University Guri Hospital

Guri-si, Gyeonggido, South Korea

Gachon University Gil Medical Center

Namdong, Incheon, South Korea

Inha University Hospital

Incheon, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul St. Mary's Hospital

Seoul, , South Korea

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Hospital Virgen Del Puerto

Plasencia, Caceres, Spain

Hospital Universitario De Getafe

Madrid, Getafe, Spain

Hospital Puerta De Hierro

Majadahonda, Madrid, Spain

Centro de Atencion Especializada (CAE) OROITU

Getxo, Vizcaya, Spain

Hospital del Mar

Barcelona, , Spain

Hospital Santa Creu I Sant Pau

Barcelona, , Spain

Fundacion ACE-Institut Catala de Neurociences Aplicades

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital Universitari de Bellvitge

Barcelona, , Spain

Hospital Reina Sofia

Córdoba, , Spain

Fundacion CITA Alzheimer

Donostia / San Sebastian, , Spain

Hospital De La Princesa

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Son Espases

Palma de Mallorca, , Spain

Hospital Univ Sant Joan de Reus, S.A.

Reus, , Spain

Hospital Doctor Peset

Valencia, , Spain

Hospital Universitario La Fe de Valencia

Valencia, , Spain

Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Cognitive Treatment & Research Unit

Crowborough, East Sussex, United Kingdom

Southern Health NHS

Southampton, Hampshire, United Kingdom

MAC UK Neuroscience Ltd

Blackpool, Lancs, United Kingdom

MAC Clinical Research

Stourton, Leeds, United Kingdom

MAC Clinical Research

Cannock, Staffordshire, United Kingdom

West London Mental Health NHS Trust

Brentford, , United Kingdom

Glasgow Memory Clinic

Glasgow, , United Kingdom

Hammersmith Hospital

London, , United Kingdom

Guildford Nuffield Hospital

London, , United Kingdom

Re-Cognition Health Ltd

London, , United Kingdom

MAC Clinical Research

Manchester, , United Kingdom

Countries

United States; Australia; Belgium; Canada; France; Germany; Hungary; Italy; Japan; Poland; Puerto Rico; Romania; South Korea; Spain; United Kingdom

References

Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.

Reference Type: DERIVED

PMID: 40603145 (View on PubMed)

Wessels AM, Lines C, Stern RA, Kost J, Voss T, Mozley LH, Furtek C, Mukai Y, Aisen PS, Cummings JL, Tariot PN, Vellas B, Dupre N, Randolph C, Michelson D, Andersen SW, Shering C, Sims JR, Egan MF. Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. Alzheimers Dement. 2020 Nov;16(11):1483-1492. doi: 10.1002/alz.12164. Epub 2020 Oct 13.

Reference Type: DERIVED

PMID: 33049114 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31764959 (View on PubMed)

Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjall 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. doi: 10.3233/JAD-160701.

Reference Type: DERIVED

PMID: 27767991 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.lillytrialguide.com/en-US/studies/mild-alzheimer-s-disease/AZES#?postal=

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Other Identifiers

I8D-MC-AZES

Identifier Type: OTHER

Identifier Source: secondary_id

2014-002601-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D5010C00009

Identifier Type: OTHER

Identifier Source: secondary_id

16023

Identifier Type: -

Identifier Source: org_study_id