AzTrials
AzTrials

Alzheimer´s DiseasePhase 2/3AMARANTHNCT02245737

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

A Phase 2/3 study testing Lanabecestat in people with Alzheimer´s Disease, run by AstraZeneca at 254 sites in 15 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 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… 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
2,218 participants
Where
254 sitesin 15 countries
Study dates
30 Sep 2014to 4 Oct 2018
Phase
Phase 2/3
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

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

254 sites in 15 countries.

254 sites in 15 countries

United States77 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • The Multiple Sclerosis Center of Atlanta

    Atlanta, Georgia, 30327

  • Atlanta Center of Medical Research

    Atlanta, Georgia, 30331

  • Senior Adults Specialty Research Inc

    Austin, Texas, 78757

  • The Memory Clinic

    Bennington, Vermont, 05201

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • SPRI Clinical Trials, LLC.

    Brooklyn, New York, 11235

  • Alzheimer's Disease and Memory Disorders Center

    Buffalo, New York, 14203

  • Valley Medical Primary Care

    Centerville, Ohio, 45459

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29401

  • Alzheimer's Memory Center

    Charlotte, North Carolina, 28270

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Ohio State University Medical Center

    Columbus, Ohio, 43221

  • The Corvallis Clinic P.C.

    Corvallis, Oregon, 97330

  • Texas Health Physicians Group

    Dallas, Texas, 75231

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Medical Group of Texas

    Fort Worth, Texas, 76104

  • Positron Research International

    Fremont, California, 94538

  • Radiant Research

    Greer, South Carolina, 29651

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Direct Helpers Medical Center

    Hialeah, Florida, 33012

  • Berma Research

    Hialeah, Florida, 33016

  • Galiz Research

    Hialeah, Florida, 33016

  • MaxBlue Institute

    Hialeah, Florida, 33018

  • University of Texas Health Services Center - Houston

    Houston, Texas, 77054

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Quillen College of Medicine, East TN State University

    Johnson City, Tennessee, 37605

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Alzheimer's Research and Treatment Center

    Lake Worth, Florida, 33449

  • Empire Neurology, PC

    Latham, New York, 12110

  • AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • Collaborative Neuroscience Network - CNS

    Long Beach, California, 90806

  • ActivMed Practices & Research, Inc

    Methuen, Massachusetts, 01844

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Medical Research Center

    Miami, Florida, 33144

  • Allied Biomedical Research Institute, Inc.

    Miami, Florida, 33155

  • Advance Medical Research Institute

    Miami, Florida, 33174

  • New Horizon Research Center

    Miami, Florida, 33175

  • JDH Medical Group, LLC

    Miami, Florida, 33186

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Clinilabs, Inc (New York)

    New York, New York, 10019

  • Columbia University Medical Center

    New York, New York, 10032

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Compass Research

    Orlando, Florida, 32806

  • IMIC, Inc.

    Palmetto Bay, Florida, 33157

  • Alzheimer's Research Company

    Paterson, New Jersey, 08759

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • St Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013

  • University of Rochester

    Rochester, New York, 14620

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84108

  • Pacific Research Network Inc

    San Diego, California, 92103

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Roskamp Institute

    Sarasota, Florida, 34243

  • Carman Research

    Smyrna, Georgia, 30080

  • Springfield Neurology Associates

    Springfield, Massachusetts, 01104

  • The Cognitive and Research Center of NJ

    Springfield, New Jersey, 07081

  • Millennium Psychiatric Associates, LLV

    St Louis, Missouri, 63141

  • St. Louis Clinical Trials, LC

    St Louis, Missouri, 63141

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33713

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Olympian Clinical Research

    Tampa, Florida, 33614

  • Compass Research

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Territory Neurology & Research Institute

    Tucson, Arizona, 85704

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • Neurology Specialists of Monmouth County

    West Long Branch, New Jersey, 07764

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

Other trials in United States

Japan31 sites

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, Hokkaido, 070-8644

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • Nippon Medical School Hospital

    Bunkyo-Ku, Tokyo, 113-8603

  • National Chiba-East-Hospital

    Chuo-ku, Chiba, 260-8712

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Koshokai aino hospital

    Ibaraki, Osaka, 567-0011

  • Ina Central Hospital

    Ina, Nagano, 396-8555

  • Saitama Medical University Hospital

    Iruma-Gun, Saitama, 350-0495

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, 247-8533

  • Nihon Kokan Hospital

    Kawasaki, Kanagawa, 210-0852

  • Katayama Medical Clinic

    Kurashiki, Okayama-ken, 701-0192

  • Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Rakuwakai Otowarehabilitation Hospital

    Kyoto, Kyoto, 607-8113

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Kyoto Minami Hospital

    Kyoto, 610-0113

  • Utano Hospital

    Kyoto, 616-8255

  • Matsumoto Medical Center

    Matsumoto, Nagano, 399-0021

  • Nozomi Memory Clinic

    Mitaka-shi, Tokyo, 181-0013

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • National Sanatorium Hokuriku Hospital

    Nanto, Toyama, 939-1893

  • National Institute for Longevity Sciences NCGG

    Ōbu, Aichi-ken, 474-0038

  • 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, 545-8586

  • Sakaguchi Clinic

    Sakai, Osaka, 593-8301

  • Sangenjaya Nakamura Mental Clinic

    Setagaya City, Tokyo, 154-0004

  • Kanauchi Medical Clinic

    Shinjuku-ku, Tokyo, 160-0023

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

  • National Sanatorium Toneyama Hospital

    Toyonaka, Osaka, 560-8552

  • Tsukuba University Hospital

    Tsukuba, Ibaraki, 305-8576

  • Memory Clinic Ochanomizu

    Tsukuba, Tokyo, 305 8576

  • Shiroma Clinic

    Urasoe, Okinawa, 901-2102

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Germany22 sites

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

    Berlin, 12163

  • Charité Universitätsmedizin Berlin

    Berlin, 12203

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • Praxis Dr. Lauter

    Bochum, North Rhine-Westphalia, 44787

  • St Josef-Hospital Bochum

    Bochum, North Rhine-Westphalia, 44791

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53105

  • Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles

    Cologne, North Rhine-Westphalia, 50935

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

  • Arztpraxis Dr. Christian Oehlwein

    Gera, Thuringia, 07551

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, Saxony-Anhalt, 06097

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66421

  • Universitätsklinikum Otto-von-Guericke-Universität

    Magdeburg, Saxony-Anhalt, 39120

  • Pharmakologisches Studienzentrum Chemnitz

    Mittweida, Saxony, 09648

  • Studien und Gedächtniszentrum München

    München, Bavaria, 80331

  • Klinikum Rechts der Isar der TU München

    München, Bavaria, 81675

  • Institut fur Psychogerontologie

    Nuremberg, Bavaria, 90402

  • Neurozentrum Prien

    Prien am Chiemsee, Bavaria, 83209

  • Neurologische Praxis Siegen

    Siegen, North Rhine-Westphalia, 57076

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Institut für Neuropsychiatrie INP3

    Wenzenbach, Bavaria, 93173

  • Studienzentrum Nord-West

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Spain19 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Santa Creu I Sant Pau

    Barcelona, 08025

  • Fundacion ACE-Institut Catala de Neurociences Aplicades

    Barcelona, 08028

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Reina Sofia

    Córdoba, 14004

  • Fundacion CITA Alzheimer

    Donostia / San Sebastian, 20009

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Centro de Atencion Especializada (CAE) OROITU

    Getxo, Vizcaya, 48993

  • Hospital Universitario De Getafe

    Madrid, Getafe, 28905

  • Hospital De La Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Puerta De Hierro

    Majadahonda, Madrid, 28222

  • Hospital Son Espases

    Palma de Mallorca, 07010

  • Hospital Virgen Del Puerto

    Plasencia, Caceres, 10600

  • Hospital Univ Sant Joan de Reus, S.A.

    Reus, 43204

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08190

  • Hospital Doctor Peset

    Valencia, 46017

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Canada15 sites

  • Clinique de la Memoire de l'Outaouais

    Gatineau, Quebec, J8T 8J1

  • NeuroSearch Developements

    Greenfield Park, Quebec, J4V 2J2

  • True North Clinical Research Halifax, LLC

    Halifax, Nova Scotia, B3S1M7

  • The Medical Arts Health Research Group

    Kamloops, British Columbia, V2C 1K7

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • Hopital Maisonneure-Rosemount

    Montreal, Quebec, H1T 2M4

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • Kawartha Regional Memory Clinic

    Peterborough, Ontario, K9H2P4

  • Hopital de L'Enfant Jesus

    Québec, Quebec, G1J 1Z4

  • 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 Western Hospital

    Toronto, Ontario, M5T2S8

  • University of British Columbia

    Vancouver, British Columbia, V6T 2B5

  • Royal Jubilee Hospital

    Victoria, British Columbia, V8R 158

Other trials in Canada

Italy15 sites

  • Università Politecnica delle Marche Torrette

    Ancona, 60126

  • IRCCS San Giovanni di Dio Fatebenefratelli

    Brescia, 25125

  • Fondazione San Raffaele Giglio di Cefalu

    Cefalù, Palermo, 90015

  • Fondazione Universitaria degli Studi G D'Annunzio

    Chieti, 66100

  • Ente Ospedaliero Ospedali Galliera

    Genova, 16132

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico

    Milan, 20122

  • Nuovo Ospedale Civile Sant'Agostino Estense

    Modena, 41010

  • Azienda Ospedaliera San Gerardo

    Monza, Milano, 20900

  • Universita Di Pisa

    Pisa, PI, 56126

  • Ospedale Degli Infermi ASR USSL 12

    Ponderano, Biella, 13875

  • Policlinico Univ. Agostino Gemelli

    Roma, 00168

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

    Roma, 00185

  • Ospedale San Giovanni Calibita Fatebenefratelli

    Roma, 00186

  • Policlinico Ospedale S. Andrea

    Roma, 00189

  • Azienda Ospedaliera Citta della Salute della Scienza Torino

    Torino, 10126

Other trials in Italy

Poland13 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, Podlaskie Voivodeship, 15-732

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

    Bydgoszcz, 85-796

  • NZOZ Wielospecjalistyczna Poradnia Lekarska

    Katowice, 40-123

  • Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala

    Katowice, 40-588

  • Centrum Zdrowia Psychicznego

    Kielce, 25411

  • Centrum Neurologii Klinicznej

    Krakow, 31-505

  • Medycyna Milorzab

    Lodz, Lódzkie, 92216

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

    Lublin, 20-064

  • Instytut Medycyny Wsi

    Lublin, 20-090

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

    Siemianowice Śląskie, 41-100

  • Centrum Medyczne

    Warsaw, 01-697

  • Centralny Szpital Kliniczny MSW

    Warsaw, 02-507

  • NZOZ Wroclawskie Centrum Alzheimerowskie

    Wroclaw, Lower Silesian Voivodeship, 53 139

Other trials in Poland

United Kingdom12 sites

  • MAC UK Neuroscience Ltd

    Blackpool, Lancs, FY20JH

  • West London Mental Health NHS Trust

    Brentford, TW8 8DS

  • MAC Clinical Research

    Cannock, Staffordshire, WS11 0BN

  • Cognitive Treatment & Research Unit

    Crowborough, East Sussex, TN6 1HB

  • Glasgow Memory Clinic

    Glasgow, G20 0XA

  • Hammersmith Hospital

    London, W12 0NN

  • Guildford Nuffield Hospital

    London, W1G 9JF

  • Re-Cognition Health Ltd

    London, W1G 9RU

  • MAC Clinical Research

    Manchester, M13 9NQ

  • Plymouth Hospitals NHS Trust

    Plymouth, Devon, PL6 8BX

  • Southern Health NHS

    Southampton, Hampshire, SO30 3JB

  • MAC Clinical Research

    Stourton, Leeds, LS10 1DU

Other trials in United Kingdom

France11 sites

  • Hopital Neuro Pierre Wertheimer

    Bron, 69677

  • CHU Dijonon

    Dijon, 21033

  • CHRU Lille - Hopital Roger Salengro

    Lille, 59037

  • CHU Hopital de la Timone

    Marseille, 13385

  • Chu de Nantes Hopital Laennec

    Nantes, 44093

  • Hopital Broca

    Paris, 75013

  • Hopital de la Pitie Salpetriere

    Paris, 75013

  • Hopital Lariboisière

    Paris, 75475

  • CHU de Toulouse Hopital Purpan

    Toulouse, Cedex 9, 31059

  • CHU de Toulouse

    Toulouse, 31052

  • Hopital des Charpennes

    Villeurbanne, 69100

Other trials in France

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Delmont Private Hospital

    Glen Iris, Victoria, 3146

  • Griffith University

    Gold Coast, Queensland, 4222

  • Heidelberg Repatriation Hospital

    Heidelberg, Victoria, 3081

  • Southern Neurology

    Kogarah, New South Wales, 2217

  • Australian Alzheimer's Research Foundation

    Nedlands, Western Australia, 6009

  • Neuro Trials Victoria Pty Ltd

    Noble Park, 3174

  • The Florey Institute of Neuroscience and Mental Health

    Parkville, Victoria, 3052

Other trials in Australia

South Korea9 sites

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

    Bucheon-si, Gyeonggi-do, 14647

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggido, 11923

  • Inha University Hospital

    Incheon, 22332

  • Gachon University Gil Medical Center

    Namdong, Incheon, 21565

  • Dong-A University Medical Center

    Seogu, Busan, 49201

  • Seoul National University Bundang Hospital

    Seongnam-si, Geonggi-do, 13620

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Belgium7 sites

  • Hopital Universitaire Brugmann Brussel

    Brussels, 1020

  • Hospital Universitaire Erasme Brussel

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Heilig Hartziekenhuis

    Roeselare, 8800

Other trials in Belgium

Hungary6 sites

  • Semmelweis Medical University

    Budapest, 1083

  • Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet

    Budapest, 1097

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

    Debrecen, 4031

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • PTE KK Pszichiatriai es Pszichoterapias Klinika

    Pécs, Baranya, 7623

  • Univerisity of Szeged

    Szeged, 6725

Other trials in Hungary

Puerto Rico4 sites

  • Santa Cruz Behavioral PSC

    Bayamón, PR, 00961

  • Ivonne Z. Jimenez-Velazquez, MD

    Carolina, 00984

  • Instituto de Neurologia Dra. Ivonne Fraga

    San Juan, PR, 00918

  • Michel A. Woodbury-Farina, MD.

    San Juan, 00918

Other trials in Puerto Rico

Romania4 sites

  • SC Med Life SA

    Bucharest, 010719

  • SC Centrul Medical Sana SRL

    Bucharest, 011025

  • Policlinica CCBR S.R.L.

    Bucharest, 30463

  • SC Med Life SA

    Timișoara, 300166

Other trials in Romania

About this study

Official title: A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)

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.

Read the 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.

Being tested
Lanabecestat, Placebo
Keywords
Alzheimer's disease, Dementia, Brain Diseases, Neurogenerative Diseases, Central Nervous System Diseases, Nervous System Diseases, Mental Disorders, Delirium, Dementia, Amnestic, Cognitive Disorders, Tauopathies
Medical subject headings
Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Mental Disorders, Neurocognitive Disorders, Tauopathies

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 NCT02245737
Study groupRoleWhat they receive
Lanabecestat 20 milligrams (mg)ExperimentalLanabecestat 20 mg given orally once daily for 104 weeks.
Receives: Drug: Lanabecestat
Lanabecestat 50 mgExperimentalLanabecestat 50 mg given orally once daily for 104 weeks.
Receives: Drug: Lanabecestat
PlaceboPlacebo comparatorPlacebo given orally once daily for 104 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)

    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, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.

    Measured: Baseline, Week 104

Secondary outcomes (16)

  1. Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (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, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.

    Measured: Baseline, Week 104

  2. Change From Baseline on the 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 was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.

    Measured: Baseline, Week 104

  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 methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.

    Measured: Baseline, Week 104

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

    The CDR-SB is a rater administered scale and impairment is scored in of the following 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, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.

    Measured: Baseline, Week 104

  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: Baseline through Loss of 1 Global Stage or Week 104

  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 greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.

    Measured: Baseline, Week 104

  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, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.

    Measured: Baseline, Week 104

  8. Pharmacodynamics (PD): 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 97

  9. PD: 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 97

  10. Change From Baseline in CSF Total Tau

    Cerebrospinal fluid samples are collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.

    Measured: Baseline, Week 97

  11. Change From Baseline in CSF Phosphorylated Tau

    Cerebrospinal fluid samples are collected for analysis of concentrations of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.

    Measured: Baseline, Week 97

  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 ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.

    Measured: Baseline, Week 104

  13. Change From Baseline in Tau PET ((Flortaucipir F18)

    Tau PET tracer (flortaucipir F18) longitudinal study measured whether lanabecestat, in participants with mild AD dementia, affected tau density and distribution over time. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the signal intensity in white matter. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.

    Measured: Baseline, Week 104

  14. Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)

    Fluorodeoxyglucose (FDG) PET evaluates the regional brain metabolic rates for glucose as a sensitive, in vivo metabolic index of brain function. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the pons + vermis assessed with composite meta and composite meta automated anatomical labeling atlas (ALL). Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.

    Measured: Baseline, Week 104

  15. Change From Baseline in Whole Brain Volume

    Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on 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 methodology with factors for treatment, baseline vMRI, intracranial volume, disease status at baseline and age at baseline.

    Measured: Baseline, Week 104

  16. Pharmacokinetics (PK): Plasma Concentration of Lanabecestat

    Measured: Week 4, post dose prior to departure from the clinic

Timeline

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

  1. First posted22 Sep 2014 (estimated)
  2. Study start30 Sep 2014
  3. Primary completion4 Oct 2018
  4. Study completion4 Oct 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02245737
Sponsor's protocol ID
16023
Other IDs
I8D-MC-AZES, 2014-002601-38, D5010C00009, 2014
Acronym
AMARANTH
Status last verified
Oct 2019
First submitted
18 Sep 2014
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

  • 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.

    PubMed 40603145

  • 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.

    PubMed 33049114

  • 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 2/3 study testing Lanabecestat in people with Alzheimer´s Disease, run by AstraZeneca at 254 sites in 15 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 254 sites in United States, Japan, Germany, Spain, Canada and 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (time frame: Baseline, Week 104). 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 NCT02245737, which also lists 4 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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