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Alzheimer's DiseasePhase 3NCT02972658

A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia

A Phase 3 study testing Lanabecestat in people with Alzheimer's Disease, run by AstraZeneca at 133 sites in 14 countries.

Terminated

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

Official record
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Trial summary

This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES. Read more about this study

Who is it for?
Ages 55 years and older
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?
No, everyone receives an active treatment
How many people
421 participants
Where
133 sitesin 14 countries
Study dates
15 Mar 2017to 2 Oct 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.

Who cannot join

  • Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.

Trial locations and contacts

133 sites in 14 countries.

133 sites in 14 countries

United States31 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • The Multiple Sclerosis Center of Atlanta

    Atlanta, Georgia, 30327

  • The Memory Clinic

    Bennington, Vermont, 05201

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • Valley Medical Primary Care

    Centerville, Ohio, 45459

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Lindner Research Center

    Cincinnati, Ohio, 45219

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • 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

  • Radiant Research

    Greer, South Carolina, 29651

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Quillen College of Medicine, East TN State University

    Johnson City, Tennessee, 37604

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • 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

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • University of Rochester School of Medicine

    Rochester, New York, 14620

  • Pacific Research Network Inc

    San Diego, California, 92103

  • Roskamp Institute

    Sarasota, Florida, 34243

  • The Cognitive and Research Center of NJ

    Springfield, New Jersey, 07081

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33713

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • Territory Neurology & Research Institute

    Tucson, Arizona, 85704

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

Other trials in United States

Japan18 sites

  • Memory Clinic Ochanomizu

    Bunkyo-ku, Tokyo, 113-0034

  • 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

  • Nihon Kokan Hospital

    Kawasaki, Kanagawa, 210-0852

  • Katayama Medical Clinic

    Kurashiki, Okayama-ken, 701-0192

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Utano Hospital

    Kyoto, 616-8255

  • 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

  • Osaka City University Hospital

    Osaka, 637086

  • Sakaguchi Clinic

    Sakai, Osaka, 593-8301

  • 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

  • Shiroma Clinic

    Urasoe, Okinawa, 901-2102

Other trials in Japan

Spain14 sites

  • Fundacion ACE-Institut Catala de Neurociences Aplicades

    Barcelona, 08014

  • Hospital Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • CITA Alzheimer

    Donostia / San Sebastian, Guipuzcoa, 20009

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Centro de Atencion Especializada (CAE) OROITU

    Getxo, Vizcaya, 48993

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario De Getafe

    Madrid, Getafe, 28905

  • Hospital De La Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Son Espases

    Palma de Mallorca, 07010

  • Hospital Virgen Del Puerto

    Plasencia, Caceres, 10600

  • Hospital Universitario Dr Pesset

    Valencia, 46017

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026

Other trials in Spain

France11 sites

  • Hopital Neuro Pierre Wertheimer

    Bron, 69677

  • CHU Bocage CMRR

    Dijon, 21079

  • CHRU de Lille- Hôpital Roger Salengro

    Lille, Cedex, 59037

  • Centre Hospitalier Universitaire La Timone

    Marseille, Cedex 05, 13385

  • Hopital Broca

    Paris, 75013

  • Hôpital de la Pitié-Salpêtrière

    Paris, 75013

  • Hôpital Fernand Widal

    Paris, 75475

  • Chu de Nantes Hopital Laennec

    Saint-Herblain, 44093

  • CHU de Toulouse Hopital Purpan

    Toulouse, Cedex, 31059

  • Centre de Recherche Clinique du Gérontopôle Cité de la Santé

    Toulouse, 31052

  • Hopital des Charpennes

    Villeurbanne, 69100

Other trials in France

Germany10 sites

  • Charité Universitätsmedizin Berlin

    Berlin, 10117

  • Charité Universitätsmedizin Berlin

    Berlin, 12203

  • DataMed Klinische Studien GmbH

    Cologne, North Rhine-Westphalia, 50935

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

  • Pharm Studienzentrum Chemnitz

    Mittweida, Saxony, 09648

  • Studien und Gedächtniszentrum München

    München, Bavaria, 80331

  • Klinikum Rechts der Isar der TU München

    München, Bavaria, 81675

  • Neurologische Praxis Siegen

    Siegen, North Rhine-Westphalia, 57076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Gemeinschaftspraxis für Neurologie und Psychiatrie

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Canada9 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

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • Elizabeth Bruyere Health Centre

    Ottawa, Ontario, KIN 5C8

  • Kawartha Regional Memory Clinic

    Peterborough, Ontario, K9H2P4

  • Hopital de L'Enfant Jesus

    Québec, Quebec, G1J 1Z4

  • Q&T Research Sherbrooke Inc

    Sherbrooke, Quebec, J1J 2G2

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

Other trials in Canada

Poland8 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

  • Centrum Zdrowia Psychicznego Biomed - Jan Latala

    Kielce, 25-411

  • Krakowska Akademia Neurologii

    Krakow, 31-505

  • Medycyna Milorzab

    Lodz, 93-118

  • Instytut Medycyny Wsi

    Lublin, 20-950

  • Centrum Medyczne Neuroprotect

    Warsaw, 01-697

Other trials in Poland

United Kingdom8 sites

  • MAC Clinical Research

    Blackpool, Lancashire, FY2 0JH

  • MAC Clinical Research

    Cannock, Staffordshire, WS11 0BN

  • Glasgow Memory Clinic

    Glasgow, G20 0XA

  • Re-Cognition Health Ltd

    Guildford, Surrey, GU2 7YD

  • West London Mental Health NHS Trust

    Isleworth, London, TW7 6FY

  • MAC Clinical Research

    Leeds, LS10 1DU

  • Re-Cognition Health Ltd

    London, Greater London, W1G 9JF

  • MAC Clinical Research-Manchester

    Manchester, Greater Manchester, M13 9NQ

Other trials in United Kingdom

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Eastern Clinical Research Unit

    Box Hill, Victoria, 3128

  • Delmont Private Hospital

    Glen Iris, Victoria, 3146

  • 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 Korea7 sites

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggido, 11923

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Inha University Hospital

    Junggu, Incheon, 22332

  • Dong-A University Medical Center

    Seogu, Busan, 49201

  • Samsung Medical Center

    Seoul, Korea, 06351

  • Asan Medical Center

    Seoul, 05505

  • Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Belgium6 sites

  • Hopital Universitaire Brugmann Brussel

    Brussels, 1020

  • Hospital Universitaire Erasme Brussel

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Romania2 sites

  • SC Med Life SA

    Bucharest, 010719

  • SC Centrul Medical Sana SRL

    Bucharest, 011025

Other trials in Romania

Hungary1 site

  • SE Neurologiai Klinika

    Budapest, 1083

Other trials in Hungary

Puerto Rico1 site

  • Santa Cruz Behavioral PSC

    Bayamón, 00961-6911

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)

This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.

Read the detailed description

Study AZFD was designed to be integrated with 104-week study AZES to form a Delayed-Start study (Study AZES-FD). Study AZES-FD was to be used to test the hypothesis that participants originally randomized to receive placebo in the double-blind feeder study AZES and switched to LY3314814 at the start of study AZFD did not "catch up" on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Week 26 of study AZFD to participants originally randomized to receive LY3314814 in the double-blind feeder study.

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

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

Study groups in NCT02972658
Study groupRoleWhat they receive
AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mgExperimentalParticipants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
Receives: Drug: Lanabecestat
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mgExperimentalParticipants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Receives: Drug: Lanabecestat
AZES Placebo/AZFD Lanabecestat 20 mgExperimentalParticipants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
Receives: Drug: Lanabecestat
AZES Placebo/AZFD Lanabecestat 50 mgExperimentalParticipants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Receives: Drug: Lanabecestat

What is being measured

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

  1. Change From Baseline Analysis 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.

    Measured: AZES Baseline through AZFD Week 26

Secondary outcomes (5)

  1. Change From Baseline Analysis 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 with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.

    Measured: AZES Baseline through AZFD Week 26

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

    FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and 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 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 determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.

    Measured: AZES Baseline through AZFD Week 26

  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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.

    Measured: AZES Baseline through AZFD Week 26

  4. Change From Baseline on the Mini-Mental Status Examination (MMSE)

    The MMSE is an instrument used to assess a participant's 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.

    Measured: AZES Baseline through AZFD Week 26

  5. Change From Baseline Analysis on the ADAS-Cog13

    ADAS-cog13 (13-item 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*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.

    Measured: AZES Baseline through AZFD Week 52

Timeline

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

  1. First posted23 Nov 2016 (estimated)
  2. Study start15 Mar 2017
  3. Primary completion2 Oct 2018
  4. Study completion2 Oct 2018

Why it stopped: As the feeder study (AZES) was stopped for futility after an independent assessment, this trial was also stopped.

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
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02972658
Sponsor's protocol ID
16557
Other IDs
I8D-MC-AZFD, 2016-003440-36, 2016
Status last verified
Nov 2019
First submitted
21 Nov 2016
Last updated
3 Dec 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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.

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 133 sites in 14 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 1 inclusion and 1 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 133 sites in United States, Japan, Spain, France, Germany and 9 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 5 Jul 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 Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (time frame: AZES Baseline through AZFD Week 26). 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 NCT02972658.

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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