AzTrials
AzTrials

Alzheimer's DiseasePhase 3DAYBREAK-ALZNCT02783573

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

A Phase 3 study testing Lanabecestat in people with Alzheimer's Disease, run by AstraZeneca at 262 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Lanabecestat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,722 participants
Where
262 sitesin 18 countries
Study dates
1 Jul 2016to 28 Sep 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

262 sites in 18 countries.

262 sites in 18 countries

United States90 sites

  • Emory University

    Atlanta, Georgia, 30329

  • Atlanta Center of Medical Research

    Atlanta, Georgia, 30331

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Georgia Regents University

    Augusta, Georgia, 30912

  • American Health Network

    Avon, Indiana, 46123

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • The Research Center of Southern California

    Carlsbad, California, 92011

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Behavioral Health Center Research

    Charlotte, North Carolina, 28211

  • Morton Plant Hospital

    Clearwater, Florida, 33755

  • Rapid Medical Research Inc

    Cleveland, Ohio, 44122

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • Medical Research Health and Education Foundation, Inc

    Columbus, Georgia, 31909

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • The Corvallis Clinic P.C.

    Corvallis, Oregon, 97330

  • WCCT Global

    Costa Mesa, California, 92626

  • Associated Neurologists, PC - Danbury

    Danbury, Connecticut, 06810

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Cohen Medical Associates P.A.

    Delray Beach, Florida, 33446

  • Michigan State University

    East Lansing, Michigan, 48824

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • University of Kansas Hospital

    Fairway, Kansas, 66160

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Univ of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Radiant Research

    Greer, South Carolina, 29650

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33021

  • Hawaii Medical Center

    Honolulu, Hawaii, 96817

  • Josephson Wallack Munshower Neurology

    Indianapolis, Indiana, 46256

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224

  • Clinical Trial Center, LLC, Psychiatry

    Jenkintown, Pennsylvania, 19046

  • NEA Baptist Clinical

    Jonesboro, Arkansas, 72401

  • Holston Medical Group Clinical Research

    Kingsport, Tennessee, 37660

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Baptist Health Medical Group

    Lexington, Kentucky, 40503

  • Associates in Neurology, PSC

    Lexington, Kentucky, 40513

  • SSM Health Dean Medical Group

    Madison, Wisconsin, 53715

  • Advanced Clinical Research LLC

    Meridian, Idaho, 83642

  • Gregory A. Kirk MD LLC

    Merritt Island, Florida, 32955

  • University of Miami

    Miami, Florida, 33136

  • Allied Biomedical Research Institute, Inc.

    Miami, Florida, 33155

  • American Health Network

    Muncie, Indiana, 47304

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • New York University Medical Center

    New York, New York, 10016

  • Pearl Clinical Research Inc.

    Norristown, Pennsylvania, 19401

  • Research Center for Clinical Studies, Inc

    Norwalk, Connecticut, 06851

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Compass Research

    Orlando, Florida, 32806

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Xenoscience

    Phoenix, Arizona, 85004

  • St Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Donald S Marks

    Plymouth, Massachusetts, 02360-4843

  • Quantum Laboratories

    Pompano Beach, Florida, 33064

  • Charlotte Neurological Services

    Port Charlotte, Florida, 33980

  • Coastal Neurology PA

    Port Royal, South Carolina, 29935

  • Summit Research Network Inc

    Portland, Oregon, 97210

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • Texas Medical Research Associates, L.L.C.

    San Antonio, Texas, 78238

  • California Research Foundation

    San Diego, California, 92103-6204

  • Pacific Research Network Inc

    San Diego, California, 92103

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Care Access Research

    Santa Clarita, California, 91321

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

  • Maine Neurology

    Scarborough, Maine, 04074

  • Four Peaks Neurology

    Scottsdale, Arizona, 85258

  • Arizona Neurology

    Scottsdale, Arizona, 85260

  • Insight Clinical Trials

    Shaker Heights, Ohio, 44122

  • California Neuroscience Research

    Sherman Oaks, California, 91403

  • Clinical Research Professionals

    St Louis, Missouri, 63141

  • Axiom Research

    Tampa, Florida, 33609

  • University of South Florida

    Tampa, Florida, 33616

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • Cotton O'Neil Clinic

    Topeka, Kansas, 66606

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Care Access Research

    Valencia, California, 91355

  • Neurology Specialists of Monmouth County

    West Long Branch, New Jersey, 07764

  • Via Christi Research, Inc.

    Wichita, Kansas, 67214

  • Alzheimers Disease Center

    Winchester, Massachusetts, 01890

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Univ CAR

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan31 sites

  • Takeda General Hospital

    Aizu-Wakamatsu, Fukushima, 965-8585

  • Shinwakai Yachiyo Hospital

    Anjo-shi, Aichi-ken, 446-8510

  • Aomori Prefectural Centeral Hospital

    Aomori, 030-8553

  • Memory Clinic Ochanomizu

    Bunkyo-ku, Tokyo, 113-0034

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Inage Neurology and Memory Clinic

    Chiba, Chiba, 263-0043

  • Keikokai P-One Clinic

    Hachioji-shi, Tokyo-To, 192-0071

  • Koseikai Kusatsu Hospital

    Hiroshima, Hiroshima, 733-0864

  • NHO Hizen Psychiatric Center

    Kanzaki-gun, Saga-ken, 842-0192

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

  • Ikeuchi Psycho Induced Internal Clinic

    Kobe, 655-0037

  • Yuge Hospital

    Kumamoto, 861-8002

  • Katayama Medical Clinic

    Kurashiki-shi, Okayama-ken, 710-0813

  • Koseikai Takeda Hospital

    Kyoto, Kyoto, 600-8558

  • Musashino Red Cross Hospital

    Musashino, Tokyo, 180-8610

  • Nagoya Ekisaikai Hospital

    Nagoya, Aichi-ken, 454-8502

  • Kojunkai Daido Hospital

    Nagoya, Aichi-ken, 457-8511

  • JADECOM Nara City Hospital

    Nara, Nara, 630-8305

  • NHO Niigata Hospital

    Niigata, 945-8585

  • Himuro Neurology Clinic

    Osaka, Osaka, 534-0021

  • Kotobukikai Tominaga Clinic

    Osaka, Osaka, 556-0015

  • NHO Hiroshima-Nishi Medical Center

    Otaki-Shi, Hiroshima, 739-0696

  • NHO Hokkaido Medical Center

    Sapporo, 063-0005

  • Jisenkai Nanko Psychiatric Institute

    Shirakawa-shi, Fukushima, 961-0021

  • Shimizu Hospital

    Shizuoka, Shizuoka, 424-8636

  • Kousaiin Hospital

    Suita-shi, Osaka, 565-0874

  • Ehime University Hospital

    Toon-Shi, Ehime, 791-0295

  • Uji Takeda Hospital

    Uji-Shi, Kyoto, 611-0021

  • Yokohama Hospital

    Yokohama, Kanagawa, 221-0801

  • JOHAS Sanin Rosai Hospital

    Yonago-shi, Tottori, 683-8605

  • Oita University Hospital

    Yufu-shi, Oita Prefecture, 879-5593

Other trials in Japan

China13 sites

  • Xuanwu Hospital-Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing 301 Hospital

    Beijing, Beijing Municipality, 100853

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital-Southeast University

    Nanjing, Jiangsu, 210009

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266071

  • Shanghai Tongji Hospital(CCBR site)

    Shanghai, Shanghai Municipality, 200065

  • Shanghai Huashan Hospital Affil to Fu Dan University

    Shanghai, 200040

  • Tangshan Worker Hospital

    Tangshan, Hebei, 063000

  • The First Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325035

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

Other trials in China

Poland12 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, Podlaskie Voivodeship, 15-732

  • NZOZ Mach-Med

    Chorzów, 41-506

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Klinika Neurologii Neuro-Care

    Katowice, 40749

  • Globe Badania Kliniczne SP Z O.O.

    Kłodzko, 57-300

  • Prywatny Gabinet Lekarski U.Chyrchel

    Lublin, 20-582

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • Euromedis Sp. z o.o.

    Szczecin, 70-111

  • Clinsante Centrum Medyczne

    Torun, 87-100

  • Centrum Medyczne

    Warsaw, 01-697

  • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED

    Warsaw, 01-737

  • NZOZ Wroclawskie Centrum Alzheimerowskie

    Wroclaw, Lower Silesian Voivodeship, 53 139

Other trials in Poland

Canada11 sites

  • University of Calgary

    Calgary, Alberta, T2N 426

  • Recherches Neuro-Hippocampe Inc

    Gatineau, Quebec, J8T 8J1

  • True North Clinical Research Halifax, LLC

    Halifax, Nova Scotia, B3S1M7

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • Kawartha Regional Memory Clinic

    Peterborough, Ontario, K9H2P4

  • CSSS-Institut Universitaire Gériatric de Sherbrooke

    Sherbrooke, Qubec, J1J3H5

  • Q&T Research Sherbrooke Inc

    Sherbrooke, Quebec, J1J 2G2

  • Toronto Memory Program

    Toronto, Ontario, M3B2S7

  • Toronto Sunnybrook Regional Cancer Center

    Toronto, Ontario, M4N 3M5

  • Douglas Hospital and Research Centre

    Verdun, Quebec, H4H 1R3

  • The Medical Arts Health Research Group

    West Vancouver, British Columbia, V7T223

Other trials in Canada

Russia11 sites

  • SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst

    Kazan', 420064

  • SIH Kemerovo Regional Clinical Hosptial

    Kemerovo, 650066

  • FSBIH Siberian Clinical Center of FMBA

    Krasnoyarsk, 660049

  • LLC City Neurological Centre Sibneuromed

    Novosibirsk, 630091

  • Novosibirsk State Medical University

    Novosibirsk, 630091

  • Ultramed

    Omsk, 644024

  • LLC Treatment and Rehabilitation

    Rostov-on-Don, 344010

  • Bekhterev Psyconeurological Institute

    Saint Petersburg, 192019

  • Central Medical Sanitary Hospital #122

    Saint Petersburg, 194291

  • RSBIH Smolensk Regional Clinical Hospital

    Smolensk, 214018

  • Regional State Institution of Healthcare Tomsk Clinica Psych

    Tomsk, 634014

Other trials in Russia

France10 sites

  • CHU d'Amiens-Picardie Hopital Sud

    Amiens, 80054

  • CHU de Caen Hopital Cote de Nacre

    Caen, 14033

  • APHM Hôpital de la Timone

    Marseille, 13385

  • Institut Claude Pompidou - CMRR

    Nice, Alpes Maritimes, 06100

  • Hôpital de la Pitié-Salpêtrière

    Paris, 75013

  • CHU Rennes/Hopital Sud

    Rennes, Ille Et Vilaine, 35064

  • CHU Saint Etienne - Hopital Nord

    Saint Priest En Jarez, Pays de la Loire Region, 42270

  • CHU Strasbourg Hôpital de Hautepierre

    Strasbourg, 67098

  • Chu de Toulouse Hopital de La Grave

    Toulouse, 31059

  • Chu De Nancy Hop D'Adultes De Brabois

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Italy10 sites

  • Spedali Civili - Universita degli Studi

    Brescia, 25123

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Ente Ospedaliero Ospedali Galliera

    Genova, 16128

  • IRCCS Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • SDN - Istituto di Ricerca Diagnostica e Nucleare

    Naples, 80143

  • Azienda Ospedaliera - Universitaria Pisana

    Pisa, 56126

  • IRCCS Santa Lucia

    Roma, 00179

  • Universita La Sapienza

    Roma, 00185

  • Policlinico Univ. Agostino Gemelli

    Rome, Lazio, 00168

  • Azienda Ospedaliera Citta della Salute della Scienza Torino

    Torino, 10126

Other trials in Italy

South Korea10 sites

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

    Bucheon-si, Gyeonggi-do, 14647

  • Dong-A University Medical Center

    Busan, Busan Gwang'yeogsi, 49201

  • Myongji Hospital

    Goyang-si, Gyeonggi-do, 13620

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Hanyang University Medical Center

    Seoul, 04763

  • Konkuk University Hospital

    Seoul, 05030

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Czechia9 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691

  • Neurohk s.r.o.

    Choceň, 565 01

  • Neuropsychiatrie s.r.o

    Hradec Králové, 50009

  • Brain-Soultherapy s.r.o

    Kladno, 27201

  • A-Shine s.r.o.

    Pilsen, 31200

  • Clintrial, s.r.o.

    Prague, 100 00

  • Neuropsychiatrie s.r.o

    Prague, 160 00

  • Medical Services Prague s.r.o.

    Prague, 16000

  • Axon Clinical, s.r.o.

    Prague, 182 00

Other trials in Czechia

Germany9 sites

  • MVZ LiO Berlin

    Berlin, 12209

  • Praxis Dr. Erich Scholz

    Böblingen, Baden-Wurttemberg, 71034

  • Diakoniekrankenhaus Henriettenstiftung Hannover

    Hanover, Lower Saxony, 30559

  • ISPG - Institut für Studien zur psychischen Gesundheit

    Mannheim, Baden-Wurttemberg, 68165

  • Klinikum der Universität München

    München, Bavaria, 81377

  • Klinikum Rechts der Isar der TU München

    München, Bavaria, 81675

  • Praxis für Neurologie und Psychiatrie Dr. med. Roth

    Ostfildern, Baden-Wurttemberg, 73760

  • Neurozentrum Sophienstraße

    Stuttgart, Baden-Wurttemberg, 70178

  • Neuropraxis München Süd

    Unterhaching, Bavaria, 82008

Other trials in Germany

Spain9 sites

  • Hospital Ntra Sra Perpetuo Socorro

    Albacete, 02006

  • Hospital del Mar

    Barcelona, 08003

  • Fundacion ACE-Institut Catala de Neurociences Aplicades

    Barcelona, 08028

  • Policlinica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20009

  • Hospital Virgen Del Puerto

    Plasencia, Caceres, 10600

  • Hospital Cardiovascular San Vicente

    San Vicent del Raspeig, Alicante, 03690

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08190

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, 500

  • National Taiwan University Hospital

    Douliu, Yunlin County, 640

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung City, 83301

  • Taipei Medical University- Shuang Ho Hospital

    New Taipei City, 23561

  • Cardinal Tien Hospital

    Sindian City, Taipei, 23148

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305

Other trials in Taiwan

Mexico8 sites

  • Mexico Centre for Clinical Research SA de CV

    Mexico City, Mexico City, 03100

  • Hospital Univ. Jose Eleuterio Gonzalez

    Monterrey, N.L., 64460

  • Accelerium Clinical Research

    Monterrey, Nuevo León, 64000

  • Centro de Estudios Clinicos y Esp Medicas SC

    Monterrey, Nuevo León, 64620

  • Avix Investigación Clínica, S.C

    Monterrey, Nuevo León, 64710

  • Instituto de Informacion en Salud Mental (INFOSAM)

    Monterrey, Nuevo León, 64710

  • Hospital Universitario de Saltillo

    Saltillo, Coahuila, 25000

  • Clinical Research Institute S C

    Tlalnepantla, Edo de Mex, 54055

Other trials in Mexico

United Kingdom8 sites

  • Charlton Lane Hospital

    Cheltenham, Gloucestershire, GL53 9DZ

  • Royal Devon and Exeter Hospital

    Exeter, Devon, EX2 5DW

  • Glasgow Memory Clinic

    Glasgow, G20 0XA

  • Re-Cognition Health Ltd

    Guildford, Surrey, GU2 7YD

  • Re-Cognition Health Ltd

    London, W1G9JF

  • Murray Royal Hospital

    Perth, Tayside Region, PH2 7BH

  • Re-Cognition Health Ltd

    Plymouth, Devon, PL6 8BT

  • Victoria Centre

    Swindon, Wiltshire, SN3 6BW

Other trials in United Kingdom

Netherlands5 sites

  • Emotional Brain B.V.

    Almere Stad, 1311 RL

  • Brain Research Center

    Amsterdam, 1081 GM

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • EB Utrecht

    Utrecht, 3511 NH

  • Isala Klinieken

    Zwolle, 8025 AB

Other trials in Netherlands

Denmark4 sites

  • CCBR-Alborg-DK

    Aalborg, 9100

  • Center For Clinical and Basic Research

    Ballerup Municipality, 2750

  • Rigshospitalet

    Copenhagen, 2100 CPH

  • Center for Clinical and Basic Research -CCBR

    Vejle, 7100

Other trials in Denmark

Portugal3 sites

  • Hospital Fernando Fonseca

    Amadora, 2700-351

  • Hospital de Braga

    Braga, 4710-243

  • Hospitals da Universidade de Coimbra

    Coimbra, 3000-075

Other trials in Portugal

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

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.

Being tested
Lanabecestat, Placebo
Keywords
dementia, brain diseases, neurodegenerative diseases, central nervous system diseases, nervous system diseases, mental disorders, delirium, dementia, amnestic, cognitive, tauopathies, memory, amyloid
Medical subject headings
Alzheimer Disease, Dementia, Brain Diseases, Neurodegenerative Diseases, Central Nervous System Diseases, Nervous System Diseases, Mental Disorders, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LanabecestatDrug

    Also called LY3314814, AZD3293

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT02783573
Study groupRoleWhat they receive
Lanabecestat 20 milligrams (mg)ExperimentalParticipants received Lanabecestat 20 mg film-coated tablets orally once daily until week 156.
Receives: Drug: Lanabecestat
Lanabecestat 50 mgExperimentalParticipants received Lanabecestat 50 mg film-coated tablets orally once daily until week 156.
Receives: Drug: Lanabecestat
Placebo/ Lanabecestat 20 mgExperimentalPlacebo given orally once daily for 78 weeks and then 20 mg of lanabecestat given orally once daily until week 156.
Receives: Drug: Lanabecestat; Drug: Placebo
Placebo/ Lanabecestat 50 mgExperimentalPlacebo given orally once daily for 78 weeks and then 50 mg of lanabecestat given orally once daily until week 156.
Receives: Drug: Lanabecestat; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score

    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.

    Measured: Baseline, Week 78

Secondary outcomes (16)

  1. Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL)

    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.

    Measured: Baseline, Week 78

  2. Change From Baseline in Functional Activities Questionnaire (FAQ) Score

    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.

    Measured: Baseline, Week 78

  3. Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score

    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.

    Measured: Baseline, Week 78

  4. Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

    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.

    Measured: Baseline, Week 78

  5. Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage

    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).

    Measured: From Loss of 1 Global Stage through Week 78

  6. Change From Baseline in Neuropsychiatric Inventory (NPI) Score

    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.

    Measured: Baseline, Week 78

  7. Change From Baseline on the Mini-Mental State Examination (MMSE)

    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.

    Measured: Baseline, Week 78

  8. Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42

    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.

    Measured: Baseline, Week 71

  9. Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40

    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.

    Measured: Baseline, Week 71

  10. Change From Baseline in CSF Biomarker Total Tau

    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.

    Measured: Baseline, Week 71

  11. Change From Baseline in CSF Biomarker Phosphorylated Tau

    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.

    Measured: Baseline, Week 71

  12. Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan

    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.

    Measured: Baseline, Week 78

  13. Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan

    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.

    Measured: Baseline, Week 78

  14. Change From Baseline in Whole Brain Volume

    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.

    Measured: Baseline, Week 78

  15. Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat

    The apparent oral clearance of lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.

    Measured: Predose, Week 4, 7, 19, 39, 45 and Week 71 post dose

  16. Population PK: Central Volume of Distribution of Lanabecestat

    The central volume of distribution for lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.

    Measured: Predose, Week 4, 7, 19, 39, 45 and week 71 post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2016 (estimated)
  2. Study start1 Jul 2016
  3. Primary completion28 Sep 2018
  4. Study completion28 Sep 2018

Why it stopped: An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,722 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02783573
Sponsor's protocol ID
16024
Other IDs
I8D-MC-AZET, 2015-005625-39, 2015
Acronym
DAYBREAK-ALZ
Status last verified
Oct 2019
First submitted
24 May 2016
Last updated
3 Dec 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 31764959

  • 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.

    PubMed 27767991

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lanabecestat in people with Alzheimer's Disease, run by AstraZeneca at 262 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 262 sites in United States, Japan, China, Poland, Canada and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score (time frame: Baseline, Week 78). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02783573, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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