Clinical trial NCT02972658: A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2016-11-23
Enrollment: 421
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
timeFrame: AZES Baseline through AZFD Week 26
Secondary outcomes:
measure: Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
timeFrame: AZES Baseline through AZFD Week 26
measure: Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
timeFrame: AZES Baseline through AZFD Week 26
measure: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
timeFrame: AZES Baseline through AZFD Week 26
measure: Change From Baseline on the Mini-Mental Status Examination (MMSE)
timeFrame: AZES Baseline through AZFD Week 26
measure: Change From Baseline Analysis on the ADAS-Cog13
timeFrame: AZES Baseline through AZFD Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Tucson
country: United States
facility: Territory Neurology & Research Institute
state: Arizona
city: San Diego
country: United States
facility: Pacific Research Network Inc
state: California
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Atlanta
country: United States
facility: The Multiple Sclerosis Center of Atlanta
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Springfield
country: United States
facility: The Cognitive and Research Center of NJ
state: New Jersey
city: Toms River
country: United States
facility: Advanced Memory Research Institute of New Jersey
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, LLC
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester School of Medicine
state: New York
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Cincinnati
country: United States
facility: Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Johnson City
country: United States
facility: Quillen College of Medicine, East TN State University
state: Tennessee
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Kogarah
country: Australia
facility: Southern Neurology
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit
state: Victoria
city: Glen Iris
country: Australia
facility: Delmont Private Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Florey Institute of Neuroscience and Mental Health
state: Victoria
city: Nedlands
country: Australia
facility: Australian Alzheimer's Research Foundation
state: Western Australia
city: Noble Park
country: Australia
facility: Neuro Trials Victoria Pty Ltd
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
city: Brussels
country: Belgium
facility: Hopital Universitaire Brugmann Brussel
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Brussel
country: Belgium
facility: Hospital Universitaire Erasme Brussel
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Roeselare
country: Belgium
facility: AZ Delta
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research Halifax, LLC
state: Nova Scotia
city: Ottawa
country: Canada
facility: Elizabeth Bruyere Health Centre
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Gatineau
country: Canada
facility: Clinique de la Memoire de l'Outaouais
state: Quebec
city: Greenfield Park
country: Canada
facility: NeuroSearch Developements
state: Quebec
city: Quebec City
country: Canada
facility: Hopital de L'Enfant Jesus
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke Inc
state: Quebec
city: Marseille
country: France
facility: Centre Hospitalier Universitaire La Timone
state: Cedex 05
city: Lille
country: France
facility: CHRU de Lille- Hôpital Roger Salengro
state: Cedex
city: Toulouse
country: France
facility: CHU de Toulouse Hopital Purpan
state: Cedex
city: Bron Cedex
country: France
facility: Hopital Neuro Pierre Wertheimer
city: Dijon
country: France
facility: CHU Bocage CMRR
city: Paris
country: France
facility: Hopital Broca
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Fernand Widal
city: Saint-Herblain
country: France
facility: Chu de Nantes Hopital Laennec
city: Toulouse
country: France
facility: Centre de Recherche Clinique du Gérontopôle Cité de la Santé
city: Villeurbanne
country: France
facility: Hopital des Charpennes
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: München
country: Germany
facility: Studien und Gedächtniszentrum München
state: Bayern
city: München
country: Germany
facility: Klinikum Rechts der Isar der TU München
state: Bayern
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Neurologie und Psychiatrie
state: Niedersachsen
city: Köln
country: Germany
facility: DataMed Klinische Studien GmbH
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: Nordrhein-Westfalen
city: Siegen
country: Germany
facility: Neurologische Praxis Siegen
state: Nordrhein-Westfalen
city: Mittweida
country: Germany
facility: Pharm Studienzentrum Chemnitz
state: Sachsen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Budapest
country: Hungary
facility: SE Neurologiai Klinika
city: Obu
country: Japan
facility: National Institute for Longevity Sciences NCGG
state: Aichi
city: Chuo-ku
country: Japan
facility: National Chiba-East-Hospital
state: Chiba
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kawasaki
country: Japan
facility: Nihon Kokan Hospital
state: Kanagawa
city: Kurashiki
country: Japan
facility: Katayama Medical Clinic
state: Okayama
city: Urasoe
country: Japan
facility: Shiroma Clinic
state: Okinawa
city: Sakai
country: Japan
facility: Sakaguchi Clinic
state: Osaka
city: Toyonaka
country: Japan
facility: National Sanatorium Toneyama Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Memory Clinic Ochanomizu
state: Tokyo
city: Bunkyo-Ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Nanto
country: Japan
facility: National Sanatorium Hokuriku Hospital
state: Toyama
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: Utano Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Seogu
country: Korea, Republic of
facility: Dong-A University Medical Center
state: Busan
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggido
city: Junggu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Białystok
country: Poland
facility: Podlaskie Centrum Psychogeriatrii
state: Podlaskie
city: Bydgoszcz
country: Poland
facility: NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska
city: Kielce
country: Poland
facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala
city: Krakow
country: Poland
facility: Krakowska Akademia Neurologii
city: Lodz
country: Poland
facility: Medycyna Milorzab
city: Lublin
country: Poland
facility: Instytut Medycyny Wsi
city: Warszawa
country: Poland
facility: Centrum Medyczne Neuroprotect
city: Bayamón
country: Puerto Rico
facility: Santa Cruz Behavioral PSC
city: Bucuresti
country: Romania
facility: SC Med Life SA
city: Bucuresti
country: Romania
facility: SC Centrul Medical Sana SRL
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Plasencia
country: Spain
facility: Hospital Virgen Del Puerto
state: Caceres
city: Madrid
country: Spain
facility: Hospital Universitario De Getafe
state: Getafe
city: San Sebastian
country: Spain
facility: CITA Alzheimer
state: Guipuzcoa
city: Getxo
country: Spain
facility: Centro de Atencion Especializada (CAE) OROITU
state: Vizcaya
city: Barcelona
country: Spain
facility: Fundacion ACE-Institut Catala de Neurociences Aplicades
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital De La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
city: Valencia
country: Spain
facility: Hospital Universitario Dr Pesset
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: London
country: United Kingdom
facility: Re-Cognition Health Ltd
state: Greater London
city: Manchester
country: United Kingdom
facility: MAC Clinical Research-Manchester
state: Greater Manchester
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research
state: Lancashire
city: Isleworth
country: United Kingdom
facility: West London Mental Health NHS Trust
state: London
city: Cannock
country: United Kingdom
facility: MAC Clinical Research
state: Staffordshire
city: Guildford
country: United Kingdom
facility: Re-Cognition Health Ltd
state: Surrey
city: Glasgow
country: United Kingdom
facility: Glasgow Memory Clinic
city: Leeds
country: United Kingdom
facility: MAC Clinical Research
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: