Clinical trial NCT02245737: An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Alzheimer´s Disease
Keywords: Alzheimer's disease
Dementia
Brain Diseases
Neurogenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Tauopathies
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-09-22
Enrollment: 2218
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Significant neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures
* History of clinically evident stroke, or multiple strokes based on history or imaging results
* History of clinically important carotid or vertebrobasilar stenosis or plaque
* History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
* Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study
* History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
* Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
* Congenital QT prolongation
* History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread
* Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders

Primary outcomes:
measure: Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
timeFrame: Baseline, Week 104
Secondary outcomes:
measure: Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
timeFrame: Baseline, Week 104
measure: Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
timeFrame: Baseline, Week 104
measure: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
timeFrame: Baseline, Week 104
measure: Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
timeFrame: Baseline, Week 104
measure: Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage
timeFrame: Baseline through Loss of 1 Global Stage or Week 104
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Score
timeFrame: Baseline, Week 104
measure: Change From Baseline on the Mini-Mental State Examination (MMSE)
timeFrame: Baseline, Week 104
measure: Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42
timeFrame: Baseline, Week 97
measure: PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40
timeFrame: Baseline, Week 97
measure: Change From Baseline in CSF Total Tau
timeFrame: Baseline, Week 97
measure: Change From Baseline in CSF Phosphorylated Tau
timeFrame: Baseline, Week 97
measure: Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan
timeFrame: Baseline, Week 104
measure: Change From Baseline in Tau PET ((Flortaucipir F18)
timeFrame: Baseline, Week 104
measure: Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)
timeFrame: Baseline, Week 104
measure: Change From Baseline in Whole Brain Volume
timeFrame: Baseline, Week 104
measure: Pharmacokinetics (PK): Plasma Concentration of Lanabecestat
timeFrame: Week 4, post dose prior to departure from the clinic
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Phoenix
country: United States
facility: St Josephs Hospital and Medical Center
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: Territory Neurology & Research Institute
state: Arizona
city: Fremont
country: United States
facility: Positron Research International
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Laguna Hills
country: United States
facility: Senior Clinical Trials, Inc.
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network - CNS
state: California
city: San Diego
country: United States
facility: Pacific Research Network Inc
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
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: Hialeah
country: United States
facility: Direct Helpers Medical Center
state: Florida
city: Hialeah
country: United States
facility: Berma Research
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Hialeah
country: United States
facility: MaxBlue Institute
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Miami
country: United States
facility: Medical Research Center
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Institute
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: JDH Medical Group, LLC
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: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: The Villages
country: United States
facility: Compass Research
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: Atlanta
country: United States
facility: Atlanta Center of Medical Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Springfield
country: United States
facility: Springfield Neurology Associates
state: Massachusetts
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Millennium Psychiatric Associates, LLV
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials, LC
state: Missouri
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Lawrenceville
country: United States
facility: AdvanceMed Research
state: New Jersey
city: Manchester
country: United States
facility: Alzheimer's Research Company
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: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: West Long Branch
country: United States
facility: Neurology Specialists of Monmouth County
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, LLC
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC.
state: New York
city: Buffalo
country: United States
facility: Alzheimer's Disease and Memory Disorders Center
state: New York
city: Latham
country: United States
facility: Empire Neurology, PC
state: New York
city: New York
country: United States
facility: Clinilabs, Inc (New York)
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
state: New York
city: Charlotte
country: United States
facility: Alzheimer's Memory Center
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Corvallis
country: United States
facility: The Corvallis Clinic P.C.
state: Oregon
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: Charleston
country: United States
facility: Roper St. Francis Healthcare
state: South Carolina
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: Austin
country: United States
facility: Senior Adults Specialty Research Inc
state: Texas
city: Dallas
country: United States
facility: Texas Health Physicians Group
state: Texas
city: Fort Worth
country: United States
facility: Medical Group of Texas
state: Texas
city: Houston
country: United States
facility: University of Texas Health Services Center - Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Kogarah
country: Australia
facility: Southern Neurology
state: New South Wales
city: Gold Coast
country: Australia
facility: Griffith University
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Glen Iris
country: Australia
facility: Delmont Private Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Heidelberg Repatriation 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: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Roeselare
country: Belgium
facility: Heilig Hartziekenhuis
city: Kamloops
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research Halifax, LLC
state: Nova Scotia
city: Ottawa
country: Canada
facility: Bruyere Continuing Care
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Regional Memory Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: CSSS-Institut Universitaire Gériatric de Sherbrooke
state: Qubec
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: Montreal
country: Canada
facility: Hopital Maisonneure-Rosemount
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: Toulouse
country: France
facility: CHU de Toulouse Hopital Purpan
state: Cedex 9
city: Bron Cedex
country: France
facility: Hopital Neuro Pierre Wertheimer
city: Dijon Cedex
country: France
facility: CHU Dijonon
city: Lille Cedex
country: France
facility: CHRU Lille - Hopital Roger Salengro
city: Marseille Cedex 05
country: France
facility: CHU Hopital de la Timone
city: Nantes
country: France
facility: Chu de Nantes Hopital Laennec
city: Paris
country: France
facility: Hopital Broca
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere
city: Paris
country: France
facility: Hopital Lariboisière
city: Toulouse
country: France
facility: CHU de Toulouse
city: Villeurbanne
country: France
facility: Hopital des Charpennes
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
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: Nürnberg
country: Germany
facility: Institut fur Psychogerontologie
state: Bayern
city: Prien am Chiemsee
country: Germany
facility: Neurozentrum Prien
state: Bayern
city: Wenzenbach
country: Germany
facility: Institut für Neuropsychiatrie INP3
state: Bayern
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West
state: Niedersachsen
city: Bochum
country: Germany
facility: Praxis Dr. Lauter
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: St Josef-Hospital Bochum
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles
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: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
city: Halle (Saale)
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Universitätsklinikum Otto-von-Guericke-Universität
state: Sachsen-Anhalt
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz
state: Sachsen
city: Gera
country: Germany
facility: Arztpraxis Dr. Christian Oehlwein
state: Thüringen
city: Berlin
country: Germany
facility: Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Pecs
country: Hungary
facility: PTE KK Pszichiatriai es Pszichoterapias Klinika
state: Baranya
city: Budapest
country: Hungary
facility: Semmelweis Medical University
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Univerisity of Szeged
city: Ponderano
country: Italy
facility: Ospedale Degli Infermi ASR USSL 12
state: Biella
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
state: Milano
city: Cefalu
country: Italy
facility: Fondazione San Raffaele Giglio di Cefalu
state: Palermo
city: Pisa
country: Italy
facility: Universita Di Pisa
state: PI
city: Ancona
country: Italy
facility: Università Politecnica delle Marche Torrette
city: Brescia
country: Italy
facility: IRCCS San Giovanni di Dio Fatebenefratelli
city: Chieti
country: Italy
facility: Fondazione Universitaria degli Studi G D'Annunzio
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera
city: Milano
country: Italy
facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico
city: Modena
country: Italy
facility: Nuovo Ospedale Civile Sant'Agostino Estense
city: Roma
country: Italy
facility: Policlinico Univ. Agostino Gemelli
city: Roma
country: Italy
facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratelli
city: Roma
country: Italy
facility: Policlinico Ospedale S. Andrea
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute della Scienza Torino
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: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
state: Hokkaido
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: Nihon Kokan Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto Prefectural University of Medicine
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Rakuwakai Otowarehabilitation Hospital
state: Kyoto
city: Ina
country: Japan
facility: Ina Central Hospital
state: Nagano
city: Matsumoto
country: Japan
facility: Matsumoto Medical Center
state: Nagano
city: Kurashiki
country: Japan
facility: Katayama Medical Clinic
state: Okayama
city: Urasoe
country: Japan
facility: Shiroma Clinic
state: Okinawa
city: Ibaraki
country: Japan
facility: Koshokai aino hospital
state: Osaka
city: Sakai
country: Japan
facility: Sakaguchi Clinic
state: Osaka
city: Toyonaka
country: Japan
facility: National Sanatorium Toneyama Hospital
state: Osaka
city: Iruma-Gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
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: Mitaka-shi
country: Japan
facility: Nozomi Memory Clinic
state: Tokyo
city: Setagaya
country: Japan
facility: Sangenjaya Nakamura Mental Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Kanauchi Medical Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Tsukuba
country: Japan
facility: Memory Clinic Ochanomizu
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: Kyoto Minami Hospital
city: Kyoto
country: Japan
facility: Utano Hospital
city: Osaka
country: Japan
facility: 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.
city: Seogu
country: Korea, Republic of
facility: Dong-A University Medical Center
state: Busan
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Geonggi-do
city: Bucheon-si
country: Korea, Republic of
facility: The Catholic University of Korea-Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggido
city: Namdong
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Wroclaw
country: Poland
facility: NZOZ Wroclawskie Centrum Alzheimerowskie
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Medycyna Milorzab
state: Lódzkie
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: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
city: Kielce
country: Poland
facility: Centrum Zdrowia Psychicznego
city: Krakow
country: Poland
facility: Centrum Neurologii Klinicznej
city: Lublin
country: Poland
facility: NZOZ Neuromed M. I M. Nastaj sp. P.
city: Lublin
country: Poland
facility: Instytut Medycyny Wsi
city: Siemianowice Śląskie
country: Poland
facility: NEURO-CARE Sp. z o.o. Sp. Komandytowa
city: Warszawa
country: Poland
facility: Centrum Medyczne
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW
city: Bayamon
country: Puerto Rico
facility: Santa Cruz Behavioral PSC
city: Carolina
country: Puerto Rico
facility: Ivonne Z. Jimenez-Velazquez, MD
city: San Juan
country: Puerto Rico
facility: Instituto de Neurologia Dra. Ivonne Fraga
city: San Juan
country: Puerto Rico
facility: Michel A. Woodbury-Farina, MD.
city: Bucuresti
country: Romania
facility: SC Med Life SA
city: Bucuresti
country: Romania
facility: SC Centrul Medical Sana SRL
city: Bucuresti
country: Romania
facility: Policlinica CCBR S.R.L.
city: Timisoara
country: Romania
facility: SC Med Life SA
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Sant Cugat del Valles
country: Spain
facility: Hospital General de Catalunya
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: Majadahonda
country: Spain
facility: Hospital Puerta De Hierro
state: Madrid
city: Getxo
country: Spain
facility: Centro de Atencion Especializada (CAE) OROITU
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Fundacion ACE-Institut Catala de Neurociences Aplicades
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
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: Reus
country: Spain
facility: Hospital Univ Sant Joan de Reus, S.A.
city: San Sebastian
country: Spain
facility: Fundacion CITA Alzheimer
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: Devon
city: Crowborough
country: United Kingdom
facility: Cognitive Treatment & Research Unit
state: East Sussex
city: Southampton
country: United Kingdom
facility: Southern Health NHS
state: Hampshire
city: Blackpool
country: United Kingdom
facility: MAC UK Neuroscience Ltd
state: Lancs
city: Stourton
country: United Kingdom
facility: MAC Clinical Research
state: Leeds
city: Cannock
country: United Kingdom
facility: MAC Clinical Research
state: Staffordshire
city: Brentford
country: United Kingdom
facility: West London Mental Health NHS Trust
city: Glasgow
country: United Kingdom
facility: Glasgow Memory Clinic
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: Guildford Nuffield Hospital
city: London
country: United Kingdom
facility: Re-Cognition Health Ltd
city: Manchester
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:
citation: 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.
citation: 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.
citation: 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.