A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia | NCT02783573 | Trialant

A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia | NCT02783573 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

Xenoscience

Phoenix, Arizona 85004, United States

St Josephs Hospital and Medical Center

Phoenix, Arizona 85013, United States

Four Peaks Neurology

Scottsdale, Arizona 85258, United States

Arizona Neurology

Scottsdale, Arizona 85260, United States

Center for Neurosciences

Tucson, Arizona 85718, United States

NEA Baptist Clinical

Jonesboro, Arkansas 72401, United States

The Research Center of Southern California

Carlsbad, California 92011, United States

WCCT Global

Costa Mesa, California 92626, United States

Neuro-Pain Medical Center

Fresno, California 93710, United States

Neurology Center of North Orange County

Fullerton, California 92835, United States

Pacific Neuroscience Medical Group

Oxnard, California 93030, United States

California Research Foundation

San Diego, California 92103-6204, United States

Pacific Research Network Inc

San Diego, California 92103, United States

Sharp Mesa Vista Hospital

San Diego, California 92123, United States

Syrentis Clinical Research

Santa Ana, California 92705, United States

Care Access Research

Santa Clarita, California 91321, United States

California Neuroscience Research

Sherman Oaks, California 91403, United States

Care Access Research

Valencia, California 91355, United States

Associated Neurologists, PC - Danbury

Danbury, Connecticut 06810, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut 06510, United States

Yale University School of Medicine

New Haven, Connecticut 06510, United States

Research Center for Clinical Studies, Inc

Norwalk, Connecticut 06851, United States

JEM Research Institute

Atlantis, Florida 33462, United States

Morton Plant Hospital

Clearwater, Florida 33755, United States

Brain Matters Research

Delray Beach, Florida 33445, United States

Cohen Medical Associates P.A.

Delray Beach, Florida 33446, United States

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida 33912, United States

Indago Research & Health Center, Inc.

Hialeah, Florida 33012, United States

Infinity Clinical Research, LLC

Hollywood, Florida 33021, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216, United States

Mayo Clinic-Jacksonville

Jacksonville, Florida 32224, United States

Gregory A. Kirk MD LLC

Merritt Island, Florida 32955, United States

University of Miami

Miami, Florida 33136, United States

Allied Biomedical Research Institute, Inc.

Miami, Florida 33155, United States

Compass Research

Orlando, Florida 32806, United States

Quantum Laboratories

Pompano Beach, Florida 33064, United States

Charlotte Neurological Services

Port Charlotte, Florida 33980, United States

Intercoastal Medical Group

Sarasota, Florida 34239, United States

Axiom Research

Tampa, Florida 33609, United States

University of South Florida

Tampa, Florida 33616, United States

Emory University

Atlanta, Georgia 30329, United States

Atlanta Center of Medical Research

Atlanta, Georgia 30331, United States

Georgia Regents University

Augusta, Georgia 30912, United States

Medical Research Health and Education Foundation, Inc

Columbus, Georgia 31909, United States

Hawaii Medical Center

Honolulu, Hawaii 96817, United States

Advanced Clinical Research LLC

Meridian, Idaho 83642, United States

American Health Network

Avon, Indiana 46123, United States

Josephson Wallack Munshower Neurology

Indianapolis, Indiana 46256, United States

American Health Network

Muncie, Indiana 47304, United States

University of Kansas Hospital

Fairway, Kansas 66160, United States

Cotton O'Neil Clinic

Topeka, Kansas 66606, United States

Via Christi Research, Inc.

Wichita, Kansas 67214, United States

Baptist Health Medical Group

Lexington, Kentucky 40503, United States

Associates in Neurology, PSC

Lexington, Kentucky 40513, United States

Eastern Maine Medical Center

Bangor, Maine 04401, United States

Maine Neurology

Scarborough, Maine 04074, United States

Boston University Medical Center

Boston, Massachusetts 02118, United States

Donald S Marks

Plymouth, Massachusetts 02360-4843, United States

Alzheimers Disease Center

Winchester, Massachusetts 01890, United States

Michigan State University

East Lansing, Michigan 48824, United States

Hattiesburg Clinic

Hattiesburg, Mississippi 39401, United States

Clinical Research Professionals

St Louis, Missouri 63141, United States

Las Vegas Medical Research

Las Vegas, Nevada 89113, United States

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey 08755, United States

Neurology Specialists of Monmouth County

West Long Branch, New Jersey 07764, United States

New York University Medical Center

New York, New York 10016, United States

Behavioral Health Center Research

Charlotte, North Carolina 28211, United States

Raleigh Neurology Associates

Raleigh, North Carolina 27607, United States

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina 27103, United States

Wake Forest Baptist Univ CAR

Winston-Salem, North Carolina 27157, United States

Rapid Medical Research Inc

Cleveland, Ohio 44122, United States

Ohio State University Medical Center

Columbus, Ohio 43210, United States

Insight Clinical Trials

Shaker Heights, Ohio 44122, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma 73112, United States

Cutting Edge Research Group

Oklahoma City, Oklahoma 73116, United States

The Corvallis Clinic P.C.

Corvallis, Oregon 97330, United States

Summit Research Network Inc

Portland, Oregon 97210, United States

Clinical Trial Center, LLC, Psychiatry

Jenkintown, Pennsylvania 19046, United States

Pearl Clinical Research Inc.

Norristown, Pennsylvania 19401, United States

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island 02914, United States

Rhode Island Hospital

Providence, Rhode Island 02903, United States

Butler Hospital

Providence, Rhode Island 02906, United States

Medical University of South Carolina

Charleston, South Carolina 29425, United States

Radiant Research

Greer, South Carolina 29650, United States

Coastal Neurology PA

Port Royal, South Carolina 29935, United States

Holston Medical Group Clinical Research

Kingsport, Tennessee 37660, United States

Univ of North Texas Health Science Center

Fort Worth, Texas 76107, United States

Texas Medical Research Associates, L.L.C.

San Antonio, Texas 78238, United States

Ericksen Research and Development

Clinton, Utah 84015, United States

SSM Health Dean Medical Group

Madison, Wisconsin 53715, United States

University of Calgary

Calgary, Alberta T2N 426, Canada

The Medical Arts Health Research Group

West Vancouver, British Columbia V7T223, Canada

True North Clinical Research Halifax, LLC

Halifax, Nova Scotia B3S1M7, Canada

Bruyere Continuing Care

Ottawa, Ontario K1N 5C8, Canada

Kawartha Regional Memory Clinic

Peterborough, Ontario K9H2P4, Canada

Toronto Memory Program

Toronto, Ontario M3B2S7, Canada

Toronto Sunnybrook Regional Cancer Center

Toronto, Ontario M4N 3M5, Canada

CSSS-Institut Universitaire Gériatric de Sherbrooke

Sherbrooke, Qubec J1J3H5, Canada

Recherches Neuro-Hippocampe Inc

Gatineau, Quebec J8T 8J1, Canada

Q&T Research Sherbrooke Inc

Sherbrooke, Quebec J1J 2G2, Canada

Douglas Hospital and Research Centre

Verdun, Quebec H4H 1R3, Canada

Xuanwu Hospital-Capital Medical University

Beijing, Beijing Municipality 100053, China

Beijing 301 Hospital

Beijing, Beijing Municipality 100853, China

Guangzhou First People's Hospital

Guangzhou, Guangdong 510180, China

Tangshan Worker Hospital

Tangshan, Hebei 063000, China

Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med

Nanjing, Jiangsu 210008, China

Zhongda Hospital-Southeast University

Nanjing, Jiangsu 210009, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu 225001, China

Qingdao Municipal Hospital

Qingdao, Shandong 266071, China

Shanghai Tongji Hospital(CCBR site)

Shanghai, Shanghai Municipality 200065, China

West China Hospital of Sichuan University

Chengdu, Sichuan 610041, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang 310003, China

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang 325035, China

Shanghai Huashan Hospital Affil to Fu Dan University

Shanghai, 200040, China

Fakultni nemocnice u sv. Anny v Brne

Brno, 65691, Czechia

Neurohk s.r.o.

Choceň, 565 01, Czechia

Neuropsychiatrie s.r.o

Hradec Králové, 50009, Czechia

Brain-Soultherapy s.r.o

Kladno, 27201, Czechia

A-Shine s.r.o.

Pilsen, 31200, Czechia

Clintrial, s.r.o.

Prague, 100 00, Czechia

Neuropsychiatrie s.r.o

Prague, 160 00, Czechia

Medical Services Prague s.r.o.

Prague, 16000, Czechia

Axon Clinical, s.r.o.

Prague, 182 00, Czechia

CCBR-Alborg-DK

Aalborg, 9100, Denmark

Center For Clinical and Basic Research

Ballerup Municipality, 2750, Denmark

Rigshospitalet

Copenhagen, 2100 CPH, Denmark

Center for Clinical and Basic Research -CCBR

Vejle, 7100, Denmark

Institut Claude Pompidou - CMRR

Nice, Alpes Maritimes 06100, France

CHU Rennes/Hopital Sud

Rennes, Ille Et Vilaine 35064, France

Chu De Nancy Hop D'Adultes De Brabois

Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France

CHU Saint Etienne - Hopital Nord

Saint Priest En Jarez, Pays de la Loire Region 42270, France

CHU d'Amiens-Picardie Hopital Sud

Amiens, 80054, France

CHU de Caen Hopital Cote de Nacre

Caen, 14033, France

APHM Hôpital de la Timone

Marseille, 13385, France

Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

CHU Strasbourg Hôpital de Hautepierre

Strasbourg, 67098, France

Chu de Toulouse Hopital de La Grave

Toulouse, 31059, France

Praxis Dr. Erich Scholz

Böblingen, Baden-Wurttemberg 71034, Germany

ISPG - Institut für Studien zur psychischen Gesundheit

Mannheim, Baden-Wurttemberg 68165, Germany

Praxis für Neurologie und Psychiatrie Dr. med. Roth

Ostfildern, Baden-Wurttemberg 73760, Germany

Neurozentrum Sophienstraße

Stuttgart, Baden-Wurttemberg 70178, Germany

Klinikum der Universität München

München, Bavaria 81377, Germany

Klinikum Rechts der Isar der TU München

München, Bavaria 81675, Germany

Neuropraxis München Süd

Unterhaching, Bavaria 82008, Germany

Diakoniekrankenhaus Henriettenstiftung Hannover

Hanover, Lower Saxony 30559, Germany

MVZ LiO Berlin

Berlin, 12209, Germany

Policlinico Univ. Agostino Gemelli

Rome, Lazio 00168, Italy

Spedali Civili - Universita degli Studi

Brescia, 25123, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Ente Ospedaliero Ospedali Galliera

Genova, 16128, Italy

IRCCS Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

SDN - Istituto di Ricerca Diagnostica e Nucleare

Naples, 80143, Italy

Azienda Ospedaliera - Universitaria Pisana

Pisa, 56126, Italy

IRCCS Santa Lucia

Roma, 00179, Italy

Universita La Sapienza

Roma, 00185, Italy

Azienda Ospedaliera Citta della Salute della Scienza Torino

Torino, 10126, Italy

Shinwakai Yachiyo Hospital

Anjo-shi, Aichi-ken 446-8510, Japan

Nagoya Ekisaikai Hospital

Nagoya, Aichi-ken 454-8502, Japan

Kojunkai Daido Hospital

Nagoya, Aichi-ken 457-8511, Japan

Inage Neurology and Memory Clinic

Chiba, Chiba 263-0043, Japan

Ehime University Hospital

Toon-Shi, Ehime 791-0295, Japan

Takeda General Hospital

Aizu-Wakamatsu, Fukushima 965-8585, Japan

Jisenkai Nanko Psychiatric Institute

Shirakawa-shi, Fukushima 961-0021, Japan

Koseikai Kusatsu Hospital

Hiroshima, Hiroshima 733-0864, Japan

NHO Hiroshima-Nishi Medical Center

Otaki-Shi, Hiroshima 739-0696, Japan

Yokohama Hospital

Yokohama, Kanagawa 221-0801, Japan

Koseikai Takeda Hospital

Kyoto, Kyoto 600-8558, Japan

Uji Takeda Hospital

Uji-Shi, Kyoto 611-0021, Japan

Nara Medical University Hospital

Kashihara, Nara 634-8522, Japan

JADECOM Nara City Hospital

Nara, Nara 630-8305, Japan

Oita University Hospital

Yufu-shi, Oita Prefecture 879-5593, Japan

Katayama Medical Clinic

Kurashiki-shi, Okayama-ken 710-0813, Japan

Himuro Neurology Clinic

Osaka, Osaka 534-0021, Japan

Kotobukikai Tominaga Clinic

Osaka, Osaka 556-0015, Japan

Kousaiin Hospital

Suita-shi, Osaka 565-0874, Japan

NHO Hizen Psychiatric Center

Kanzaki-gun, Saga-ken 842-0192, Japan

Shimizu Hospital

Shizuoka, Shizuoka 424-8636, Japan

Memory Clinic Ochanomizu

Bunkyo-ku, Tokyo 113-0034, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo 113-8431, Japan

Musashino Red Cross Hospital

Musashino, Tokyo 180-8610, Japan

Keikokai P-One Clinic

Hachioji-shi, Tokyo-To 192-0071, Japan

JOHAS Sanin Rosai Hospital

Yonago-shi, Tottori 683-8605, Japan

Aomori Prefectural Centeral Hospital

Aomori, 030-8553, Japan

Ikeuchi Psycho Induced Internal Clinic

Kobe, 655-0037, Japan

Yuge Hospital

Kumamoto, 861-8002, Japan

NHO Niigata Hospital

Niigata, 945-8585, Japan

NHO Hokkaido Medical Center

Sapporo, 063-0005, Japan

Hospital Universitario de Saltillo

Saltillo, Coahuila 25000, Mexico

Clinical Research Institute S C

Tlalnepantla, Edo de Mex 54055, Mexico

Mexico Centre for Clinical Research SA de CV

Mexico City, Mexico City 03100, Mexico

Hospital Univ. Jose Eleuterio Gonzalez

Monterrey, N.L. 64460, Mexico

Accelerium Clinical Research

Monterrey, Nuevo León 64000, Mexico

Centro de Estudios Clinicos y Esp Medicas SC

Monterrey, Nuevo León 64620, Mexico

Avix Investigación Clínica, S.C

Monterrey, Nuevo León 64710, Mexico

Instituto de Informacion en Salud Mental (INFOSAM)

Monterrey, Nuevo León 64710, Mexico

Emotional Brain B.V.

Almere Stad, 1311 RL, Netherlands

Brain Research Center

Amsterdam, 1081 GM, Netherlands

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

EB Utrecht

Utrecht, 3511 NH, Netherlands

Isala Klinieken

Zwolle, 8025 AB, Netherlands

NZOZ Wroclawskie Centrum Alzheimerowskie

Wroclaw, Lower Silesian Voivodeship 53 139, Poland

Podlaskie Centrum Psychogeriatrii

Bialystok, Podlaskie Voivodeship 15-732, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship 80-952, Poland

NZOZ Mach-Med

Chorzów, 41-506, Poland

Klinika Neurologii Neuro-Care

Katowice, 40749, Poland

Globe Badania Kliniczne SP Z O.O.

Kłodzko, 57-300, Poland

Prywatny Gabinet Lekarski U.Chyrchel

Lublin, 20-582, Poland

Centrum Medyczne Medyk

Rzeszów, 35-055, Poland

Euromedis Sp. z o.o.

Szczecin, 70-111, Poland

Clinsante Centrum Medyczne

Torun, 87-100, Poland

Centrum Medyczne

Warsaw, 01-697, Poland

Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED

Warsaw, 01-737, Poland

Hospital Fernando Fonseca

Amadora, 2700-351, Portugal

Hospital de Braga

Braga, 4710-243, Portugal

Hospitals da Universidade de Coimbra

Coimbra, 3000-075, Portugal

SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst

Kazan', 420064, Russia

SIH Kemerovo Regional Clinical Hosptial

Kemerovo, 650066, Russia

FSBIH Siberian Clinical Center of FMBA

Krasnoyarsk, 660049, Russia

LLC City Neurological Centre Sibneuromed

Novosibirsk, 630091, Russia

Novosibirsk State Medical University

Novosibirsk, 630091, Russia

Ultramed

Omsk, 644024, Russia

LLC Treatment and Rehabilitation

Rostov-on-Don, 344010, Russia

Bekhterev Psyconeurological Institute

Saint Petersburg, 192019, Russia

Central Medical Sanitary Hospital #122

Saint Petersburg, 194291, Russia

RSBIH Smolensk Regional Clinical Hospital

Smolensk, 214018, Russia

Regional State Institution of Healthcare Tomsk Clinica Psych

Tomsk, 634014, Russia

Dong-A University Medical Center

Busan, Busan Gwang'yeogsi 49201, South Korea

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

Bucheon-si, Gyeonggi-do 14647, South Korea

Myongji Hospital

Goyang-si, Gyeonggi-do 13620, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620, South Korea

Inha University Hospital

Incheon, 22332, South Korea

Korea University Anam Hospital

Seoul, 02841, South Korea

Seoul National University Hospital

Seoul, 03080, South Korea

Hanyang University Medical Center

Seoul, 04763, South Korea

Konkuk University Hospital

Seoul, 05030, South Korea

Samsung Medical Center

Seoul, 06351, South Korea

Hospital Cardiovascular San Vicente

San Vicent del Raspeig, Alicante 03690, Spain

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona 08190, Spain

Hospital Mutua de Terrassa

Terrassa, Barcelona 08221, Spain

Hospital Virgen Del Puerto

Plasencia, Caceres 10600, Spain

Policlinica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa 20009, Spain

Hospital Ntra Sra Perpetuo Socorro

Albacete, 02006, Spain

Hospital del Mar

Barcelona, 08003, Spain

Fundacion ACE-Institut Catala de Neurociences Aplicades

Barcelona, 08028, Spain

Hospital Universitario La Fe de Valencia

Valencia, 46026, Spain

Cardinal Tien Hospital

Sindian City, Taipei 23148, Taiwan

National Taiwan University Hospital

Douliu, Yunlin County 640, Taiwan

Changhua Christian Hospital

Changhua, 500, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, 83301, Taiwan

Taipei Medical University- Shuang Ho Hospital

New Taipei City, 23561, Taiwan

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan City, 33305, Taiwan

Royal Devon and Exeter Hospital

Exeter, Devon EX2 5DW, United Kingdom

Re-Cognition Health Ltd

Plymouth, Devon PL6 8BT, United Kingdom

Charlton Lane Hospital

Cheltenham, Gloucestershire GL53 9DZ, United Kingdom

Re-Cognition Health Ltd

Guildford, Surrey GU2 7YD, United Kingdom

Murray Royal Hospital

Perth, Tayside Region PH2 7BH, United Kingdom

Victoria Centre

Swindon, Wiltshire SN3 6BW, United Kingdom

Glasgow Memory Clinic

Glasgow, G20 0XA, United Kingdom

Re-Cognition Health Ltd

London, W1G9JF, United Kingdom