Clinical trial NCT02783573: A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia
Official title: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: dementia
brain diseases
neurodegenerative diseases
central nervous system diseases
nervous system diseases
mental disorders
delirium, dementia, amnestic, cognitive
tauopathies
memory
amyloid
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2016-05-26
Enrollment: 1722
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 main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.


Eligibility criteria: Inclusion Criteria:

* Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
* MMSE score of 20 to 26 inclusive at screening visit.
* For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
* Evidence of amyloid pathology.
* The participant must have a reliable study partner with whom he/she cohabits or has regular contact.

Exclusion Criteria:

* Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
* Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
* Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
* Congenital QT prolongation.
* Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
* A corrected QT (QTcF) interval measurement \>470 milliseconds (men and women) at screening (as determined at the investigational site).
* History of malignant cancer within the last 5 years.
* History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
* Calculated creatinine clearance \<30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
* Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Primary outcomes:
measure: Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score
timeFrame: Baseline, Week 78
Secondary outcomes:
measure: Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL)
timeFrame: Baseline, Week 78
measure: Change From Baseline in Functional Activities Questionnaire (FAQ) Score
timeFrame: Baseline, Week 78
measure: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
timeFrame: Baseline, Week 78
measure: Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
timeFrame: Baseline, Week 78
measure: Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage
timeFrame: From Loss of 1 Global Stage through Week 78
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Score
timeFrame: Baseline, Week 78
measure: Change From Baseline on the Mini-Mental State Examination (MMSE)
timeFrame: Baseline, Week 78
measure: Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42
timeFrame: Baseline, Week 71
measure: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40
timeFrame: Baseline, Week 71
measure: Change From Baseline in CSF Biomarker Total Tau
timeFrame: Baseline, Week 71
measure: Change From Baseline in CSF Biomarker Phosphorylated Tau
timeFrame: Baseline, Week 71
measure: Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan
timeFrame: Baseline, Week 78
measure: Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan
timeFrame: Baseline, Week 78
measure: Change From Baseline in Whole Brain Volume
timeFrame: Baseline, Week 78
measure: Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat
timeFrame: Predose, Week 4, 7, 19, 39, 45 and Week 71 post dose
measure: Population PK: Central Volume of Distribution of Lanabecestat
timeFrame: Predose, Week 4, 7, 19, 39, 45 and week 71 post dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience
state: Arizona
city: Phoenix
country: United States
facility: St Josephs Hospital and Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Four Peaks Neurology
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Neurology
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinical
state: Arkansas
city: Carlsbad
country: United States
facility: The Research Center of Southern California
state: California
city: Costa Mesa
country: United States
facility: WCCT Global
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: Pacific Research Network Inc
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Santa Clarita
country: United States
facility: Care Access Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Valencia
country: United States
facility: Care Access Research
state: California
city: Danbury
country: United States
facility: Associated Neurologists, PC - Danbury
state: Connecticut
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Delray Beach
country: United States
facility: Cohen Medical Associates P.A.
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic-Jacksonville
state: Florida
city: Merritt Island
country: United States
facility: Gregory A. Kirk MD LLC
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Neurological Services
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Tampa
country: United States
facility: Axiom Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center of Medical Research
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Columbus
country: United States
facility: Medical Research Health and Education Foundation, Inc
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Medical Center
state: Hawaii
city: Meridian
country: United States
facility: Advanced Clinical Research LLC
state: Idaho
city: Avon
country: United States
facility: American Health Network
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology
state: Indiana
city: Muncie
country: United States
facility: American Health Network
state: Indiana
city: Fairway
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Wichita
country: United States
facility: Via Christi Research, Inc.
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Medical Group
state: Kentucky
city: Lexington
country: United States
facility: Associates in Neurology, PSC
state: Kentucky
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Scarborough
country: United States
facility: Maine Neurology
state: Maine
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Plymouth
country: United States
facility: Donald S Marks
state: Massachusetts
city: Winchester
country: United States
facility: Alzheimers Disease Center
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Toms River
country: United States
facility: Advanced Memory Research Institute of New Jersey
state: New Jersey
city: West Long Branch
country: United States
facility: Neurology Specialists of Monmouth County
state: New Jersey
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Charlotte
country: United States
facility: Behavioral Health Center Research
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Univ CAR
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research Inc
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Shaker Heights
country: United States
facility: Insight Clinical Trials
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Corvallis
country: United States
facility: The Corvallis Clinic P.C.
state: Oregon
city: Portland
country: United States
facility: Summit Research Network Inc
state: Oregon
city: Jenkintown
country: United States
facility: Clinical Trial Center, LLC, Psychiatry
state: Pennsylvania
city: Norristown
country: United States
facility: Pearl Clinical Research Inc.
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Port Royal
country: United States
facility: Coastal Neurology PA
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group Clinical Research
state: Tennessee
city: Fort Worth
country: United States
facility: Univ of North Texas Health Science Center
state: Texas
city: San Antonio
country: United States
facility: Texas Medical Research Associates, L.L.C.
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Madison
country: United States
facility: SSM Health Dean Medical Group
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: West Vancouver
country: Canada
facility: The Medical Arts Health Research Group
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 Sunnybrook Regional Cancer Center
state: Ontario
city: Sherbrooke
country: Canada
facility: CSSS-Institut Universitaire Gériatric de Sherbrooke
state: Qubec
city: Gatineau
country: Canada
facility: Recherches Neuro-Hippocampe Inc
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke Inc
state: Quebec
city: Verdun
country: Canada
facility: Douglas Hospital and Research Centre
state: Quebec
city: Beijing
country: China
facility: Xuanwu Hospital-Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing 301 Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Tangshan
country: China
facility: Tangshan Worker Hospital
state: Hebei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital-Southeast University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tongji Hospital(CCBR site)
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Huashan Hospital Affil to Fu Dan University
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Chocen
country: Czechia
facility: Neurohk s.r.o.
city: Hradec Kralove
country: Czechia
facility: Neuropsychiatrie s.r.o
city: Kladno
country: Czechia
facility: Brain-Soultherapy s.r.o
city: Plzen
country: Czechia
facility: A-Shine s.r.o.
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
city: Praha 6
country: Czechia
facility: Neuropsychiatrie s.r.o
city: Praha 6
country: Czechia
facility: Medical Services Prague s.r.o.
city: Praha 8
country: Czechia
facility: Axon Clinical, s.r.o.
city: Aalborg
country: Denmark
facility: CCBR-Alborg-DK
city: Ballerup
country: Denmark
facility: Center For Clinical and Basic Research
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Vejle
country: Denmark
facility: Center for Clinical and Basic Research -CCBR
city: Nice
country: France
facility: Institut Claude Pompidou - CMRR
state: Alpes Maritimes
city: Rennes Cedex
country: France
facility: CHU Rennes/Hopital Sud
state: Ille Et Vilaine
city: Saint Priest en Jarez
country: France
facility: CHU Saint Etienne - Hopital Nord
state: Loire
city: Vandœuvre-lès-Nancy
country: France
facility: Chu De Nancy Hop D'Adultes De Brabois
state: Meurthe-et-Moselle
city: Amiens Cedex 1
country: France
facility: CHU d'Amiens-Picardie Hopital Sud
city: Caen Cedex
country: France
facility: CHU de Caen Hopital Cote de Nacre
city: Marseille
country: France
facility: APHM Hôpital de la Timone
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
city: Strasbourg Cedex
country: France
facility: CHU Strasbourg Hôpital de Hautepierre
city: Toulouse Cedex
country: France
facility: Chu de Toulouse Hopital de La Grave
city: Böblingen
country: Germany
facility: Praxis Dr. Erich Scholz
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: ISPG - Institut für Studien zur psychischen Gesundheit
state: Baden-Württemberg
city: Ostfildern
country: Germany
facility: Praxis für Neurologie und Psychiatrie Dr. med. Roth
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Neurozentrum Sophienstraße
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
city: München
country: Germany
facility: Klinikum Rechts der Isar der TU München
state: Bayern
city: Unterhaching
country: Germany
facility: Neuropraxis München Süd
state: Bayern
city: Hannover
country: Germany
facility: Diakoniekrankenhaus Henriettenstiftung Hannover
state: Niedersachsen
city: Berlin
country: Germany
facility: MVZ LiO Berlin
city: Roma
country: Italy
facility: Policlinico Univ. Agostino Gemelli
state: Lazio
city: Brescia
country: Italy
facility: Spedali Civili - Universita degli Studi
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino
city: Napoli
country: Italy
facility: SDN - Istituto di Ricerca Diagnostica e Nucleare
city: Pisa
country: Italy
facility: Azienda Ospedaliera - Universitaria Pisana
city: Roma
country: Italy
facility: IRCCS Santa Lucia
city: Roma
country: Italy
facility: Universita La Sapienza
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute della Scienza Torino
city: Anjo-shi
country: Japan
facility: Shinwakai Yachiyo Hospital
state: Aichi-Ken
city: Nagoya-shi
country: Japan
facility: Nagoya Ekisaikai Hospital
state: Aichi-Ken
city: Nagoya-Shi
country: Japan
facility: Kojunkai Daido Hospital
state: Aichi-Ken
city: Chiba-shi
country: Japan
facility: Inage Neurology and Memory Clinic
state: Chiba-Ken
city: Toon-Shi
country: Japan
facility: Ehime University Hospital
state: Ehime-Ken
city: Shirakawa-shi
country: Japan
facility: Jisenkai Nanko Psychiatric Institute
state: Fukushima-Ken
city: Aizu-Wakamatsu
country: Japan
facility: Takeda General Hospital
state: Fukushima
city: Hiroshima-shi
country: Japan
facility: Koseikai Kusatsu Hospital
state: Hiroshima-Ken
city: Otaki-Shi
country: Japan
facility: NHO Hiroshima-Nishi Medical Center
state: Hiroshima-Ken
city: Yokohama
country: Japan
facility: Yokohama Hospital
state: Kanagawa
city: Kyoto-Shi
country: Japan
facility: Koseikai Takeda Hospital
state: Kyoto-Fu
city: Uji-Shi
country: Japan
facility: Uji Takeda Hospital
state: Kyoto-Fu
city: Nara-Shi
country: Japan
facility: JADECOM Nara City Hospital
state: Nara-Ken
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Yufu-shi
country: Japan
facility: Oita University Hospital
state: Oita-Ken
city: Kurashiki-shi
country: Japan
facility: Katayama Medical Clinic
state: Okayama-Ken
city: Osaka-Shi
country: Japan
facility: Himuro Neurology Clinic
state: Osaka-Fu
city: Osaka-shi
country: Japan
facility: Kotobukikai Tominaga Clinic
state: Osaka-Fu
city: Suita-shi
country: Japan
facility: Kousaiin Hospital
state: Osaka-Fu
city: Kanzaki-gun
country: Japan
facility: NHO Hizen Psychiatric Center
state: Saga-Ken
city: Shizuoka-shi
country: Japan
facility: Shimizu Hospital
state: Shizuoka
city: Hachioji-shi
country: Japan
facility: Keikokai P-One Clinic
state: Tokyo-To
city: Bunkyo-ku
country: Japan
facility: Memory Clinic Ochanomizu
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Musashino
country: Japan
facility: Musashino Red Cross Hospital
state: Tokyo
city: Yonago-shi
country: Japan
facility: JOHAS Sanin Rosai Hospital
state: Tottori-Ken
city: Aomori
country: Japan
facility: Aomori Prefectural Centeral Hospital
city: Kobe-shi
country: Japan
facility: Ikeuchi Psycho Induced Internal Clinic
city: Kumamoto
country: Japan
facility: Yuge Hospital
city: Niigata
country: Japan
facility: NHO Niigata Hospital
city: Sapporo-shi
country: Japan
facility: NHO Hokkaido Medical Center
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
state: Busan Gwang'yeogsi
city: Bucheon-si
country: Korea, Republic of
facility: The Catholic University of Korea-Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Saltillo
country: Mexico
facility: Hospital Universitario de Saltillo
state: Coahuila
city: Mexico City
country: Mexico
facility: Mexico Centre for Clinical Research SA de CV
state: Distrito Federal
city: Tlalnepantla
country: Mexico
facility: Clinical Research Institute S C
state: Edo De Mex
city: Monterrey
country: Mexico
facility: Hospital Univ. Jose Eleuterio Gonzalez
state: N.l.
city: Monterrey
country: Mexico
facility: Instituto de Informacion en Salud Mental (INFOSAM)
state: NL
city: Monterrey
country: Mexico
facility: Accelerium Clinical Research
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Centro de Estudios Clinicos y Esp Medicas SC
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Avix Investigación Clínica, S.C
state: Nuevo León
city: Almere
country: Netherlands
facility: Emotional Brain B.V.
city: Amsterdam
country: Netherlands
facility: Brain Research Center
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Utrecht
country: Netherlands
facility: EB Utrecht
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Wroclaw
country: Poland
facility: NZOZ Wroclawskie Centrum Alzheimerowskie
state: Dolnoslaskie
city: Białystok
country: Poland
facility: Podlaskie Centrum Psychogeriatrii
state: Podlaskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Chorzow
country: Poland
facility: NZOZ Mach-Med
city: Katowice
country: Poland
facility: Klinika Neurologii Neuro-Care
city: Klodzko
country: Poland
facility: Globe Badania Kliniczne SP Z O.O.
city: Lublin
country: Poland
facility: Prywatny Gabinet Lekarski U.Chyrchel
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Szczecin
country: Poland
facility: Euromedis Sp. z o.o.
city: Torun
country: Poland
facility: Clinsante Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Medyczne
city: Warszawa
country: Poland
facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED
city: Amadora
country: Portugal
facility: Hospital Fernando Fonseca
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Hospitals da Universidade de Coimbra
city: Kazan
country: Russian Federation
facility: SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst
city: Kemerovo
country: Russian Federation
facility: SIH Kemerovo Regional Clinical Hosptial
city: Krasnoyarsk
country: Russian Federation
facility: FSBIH Siberian Clinical Center of FMBA
city: Novosibirsk
country: Russian Federation
facility: LLC City Neurological Centre Sibneuromed
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Omsk
country: Russian Federation
facility: Ultramed
city: Rostov-on-Don
country: Russian Federation
facility: LLC Treatment and Rehabilitation
city: Smolensk
country: Russian Federation
facility: RSBIH Smolensk Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Bekhterev Psyconeurological Institute
city: St. Petersburg
country: Russian Federation
facility: Central Medical Sanitary Hospital #122
city: Tomsk
country: Russian Federation
facility: Regional State Institution of Healthcare Tomsk Clinica Psych
city: San Vicente del Raspeig
country: Spain
facility: Hospital Cardiovascular San Vicente
state: Alicante
city: Sant Cugat del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Plasencia
country: Spain
facility: Hospital Virgen Del Puerto
state: Caceres
city: Donostia
country: Spain
facility: Policlinica Guipuzcoa
state: Guipuzcoa
city: Albacete
country: Spain
facility: Hospital Ntra Sra Perpetuo Socorro
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Fundacion ACE-Institut Catala de Neurociences Aplicades
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Sindian City
country: Taiwan
facility: Cardinal Tien Hospital
state: Taipei County
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital
state: Yunlin County
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung
city: New Taipei
country: Taiwan
facility: Taipei Medical University- Shuang Ho Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: Devon
city: Plymouth
country: United Kingdom
facility: Re-Cognition Health Ltd
state: Devon
city: Cheltenham
country: United Kingdom
facility: Charlton Lane Hospital
state: Gloucestershire
city: Guildford
country: United Kingdom
facility: Re-Cognition Health Ltd
state: Surrey
city: Perth
country: United Kingdom
facility: Murray Royal Hospital
state: Tayside Region
city: Swindon
country: United Kingdom
facility: Victoria Centre
state: Wiltshire
city: Glasgow
country: United Kingdom
facility: Glasgow Memory Clinic
city: London
country: United Kingdom
facility: Re-Cognition Health Ltd
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, 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.