Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,535

Participants

Timeline

Start Date

December 23, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2027

Conditions
Alzheimer Disease
Interventions
DRUG

AR1001

AR1001 Active Oral Tablet

DRUG

Placebo

Placebo Oral Tablet

Trial Locations (198)

9362

Sanos Clinic - Gandrup, Gandrup

12553

Mid-Hudson Medical Research, PLLC - New Windsor, New Windsor

13620

Seoul National University Bundang Hospital, Seongnam-si

14226

Dent Neuroscience Research Center, Amherst

21565

Gachon University Gil Medical Center, Incheon

22031

Cognition Health Corporation, Fairfax

22043

Integrated Neurology Services, Falls Church

24253

Hallym University Chuncheon Sacred Heart Hospital, Chuncheon

25827

Vaught Neurological Services, PLLC, Crab Orchard

27103

Accellacare of Winston-Salem, Triad Neurological Associates, Winston-Salem

27410

Triad Clinical Trials, Greensboro

28105

AMC Research, LLC, Matthews

30030

iResearch -Atlanta, Atlanta

Accel Research Sites, Decatur

30327

Atlanta Neuroscience Institute, Atlanta

31405

iResearch, Savannah

32117

Arrow Clinical Trial, Daytona Beach

32127

Progressive Medical Research, Port Orange

32162

Charter Research - The Villages, The Villages

32751

ClinCloud LLC, Maitland

32789

Conquest Research, Winter Park

32803

Topaz Clinical Research, Apopka

Charter Research - Orlando, Orlando

32806

K2 Medical Research, Orlando

32940

ClinCloud, LLC Melbourn, Viera

33014

Meridian International Research, Inc, Miami Gardens

33135

Verus Clinical Research, Corp, Miami

Vitae Research Center, LLC, Miami

33145

Caro Medcenter and Community Research, Miami

33155

Allied Biomedical Research Institute, Inc, Miami

33169

Future Life Clinical Trials, Miami

33176

Brainstorm Research, Miami

33462

JEM Research Institute, Palm Beach

33470

Brainstorm Research - Loxahatchee, Loxahatchee Groves

33614

Angels Clinical Research Institute, Inc. - Tampa, Tampa

33756

BayCare Health System, Inc, Clearwater

34711

Vertex Research Group, Clermont

35033

CHU Rennes - Hopital Pontchaillou, Rennes

37909

Center for Biomedical Research, LLC - Genesis Neuroscience Clinic, Knoxville

38018

Neurology Clinic, P.C., Cordova

41013

Hospital Universitario Virgen del Rocio, Seville

41404

Kyungpook National University Chilgok Hospital, Daegu

44718

NeuroScience Research Center, LLC, Canton

45432

American Clinical Research Institute, LLC, Dayton

53226

Medical College of Wisconsin, Wauwatosa

57702

Health Concepts, Rapid City

60611

Re:Cognition Health - Chicago, Chicago

61469

Chonnam National University Hospital, Gwangju

65721

Sharlin Health Neuroscience Research Center, Ozark

67200

CHRU de Strasbourg - Hopital de Hautepierre, Strasbourg

68165

Institut fuer Studien zur Psychischen Gesundheit (ISPG), Mannheim

68526

Alivation, Lincoln

70072

Tandem Clinical Research, New Orleans

75231

Kerwin Medical Center, Dallas

77030

Cognition Health Corporation- Texas, Houston

77074

Clinical Trial Network - Houston, Houston

77702

Gadolin Research LLC, Beaumont

79410

Bhupesh Dihenia, MD, PA, Lubbock

80113

CenExel Rocky Mountain Clinical Research, Englewood

80210

Denver Neurological Research, Denver

80218

Mile High Research Center, Denver

84107

Wasatch Clinical Research, LLC, Salt Lake City

85012

IMA Clinical Research Phoenix, Phoenix

85253

Perseverance Research Center, LLC, Scottsdale

85258

Clinical Endpoints - N. Scottsdale, Scottsdale

85282

Voyage Medical, Tempe

85351

Banner Sun Health Research Institute, Sun City

89106

Wake Research- Clinical Research Center of Nevada, LLC, Las Vegas

91105

Havana Research Institute, Pasadena

91325

Valley Clinical Trials, INC, Northridge

92037

Kaizen Brain Center, San Diego

92069

The Neuron Clinic, San Marcos

92562

Esperanza Clinical, Murrieta

92835

Fullerton Neurology and Headache Center, Fullerton

93710

Neuro-Pain Medical Center, Fresno

94010

Sutter Health's Palo Alto Medical Foundation, Burlingame

94305

Stanford Neuroscience Health Center, Stanford

95124

Adaptive Research, San Jose

99201

Kingfisher Cooperative, Spokane

02740

BTC of New Bedford, New Bedford

02459

Boston Center for Memory, Newton

02360

Headlands Research - Eastern MA, Plymouth

02451

Boston Paincare, Waltham

08755

Advanced Memory Research Institute of New Jersey, Toms River

02914

Rhode Island Mood and Memory REsearch, East Providence

Unknown

Centricity Research - Halifax, Halifax

Okanagan Clinical Trials, Kelowna

Parkwood Institute, London

Baycrest Academy for Research and Education, North York

Kawartha Centre - Redefining Healthy Aging, Peterborough

Centricity Research, Toronto

Sunnybrook Health Sciences Centre, Toronto

University Health Network-Toronto Western Hospital, Toronto

Royal Jubilee Hospital, Victoria

Medical Arts Health Research Group - West Vancouver, West Vancouver

Beijing Anding Hospital Capital Medical University, Beijing

Beijing Friendship Hospital,Capital Medical University, Beijing

Beijing Tiantan Hospital, Capital Medical University, Beijing

Peking Union Medical College Hospital, Beijing

Peking University Sixth Hospital, Beijing

Xuanwu Hospital Capital Medical University, Beijing

The First Hospital of Jilin University, Changchun

Xiangya Hospital of Central South University, Changsha

The First Affiliated Hospital of Chongqing Medical University, Chongqing

Guangdong Provincial People's Hospital, Guangzhou

The Affiliated Brain Hospital Of Guangzhou Medical University, Guangzhou

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

Anhui Provincial Hospital, Hefei

Tianjin Medical University General Hospital, Heping

The Second Affiliated Hospital of Nanchang University, Nanchang

Nanjing Drum Tower Hospital, Nanjing

The Second Affiliated Hospital of Nanjing Medical University, Nanjing

Huashan Hospital affiliated to Fudan University, Shanghai

Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

The First Hospital of Hebei Medical University, Shijiazhuang

The First Affiliated Hospital of Soochow University, Suzhou

The Second Affiliated Hospital of Soochow University, Suzhou

Tongji Hospital Of Tongji University, Wuhan

Xuzhou Central Hospital, Xuzhou

Fakultni nemocnice u sv. Anny v Brne, Brno

NeuroHK s.r.o., Choceň

Fakultni nemocnice Hradec Kralove, Hradec Králové

Ambulance Smrkova ulice (A-Shine s.r.o.), Pilsen

FORBELI s.r.o, Prague

INEP Medical s.r.o., Prague

Neuropsychiatrie s.r.o., Prague

Sanos Clinic - Herlev, Herlev

Sanos Clinic Syddanmark - Vejle, Vejle

CHU de Lille - Hopital Roger Salengro, Lille

AP-HM - Hopital de la Timone, Marseille

CHU de Nantes - Hopital Nord Laennec, Nantes

AP-HP Hopital Broca, Paris

AP-HP Hopital Lariboisiere, Paris

AP-HP Hopital Pitie-Salpetriere, Paris

CHU de Toulouse - Hopital La Grave, Toulouse

HCL - Hopital des Charpennes, Villeurbanne

Universitaetsklinikum Aachen, AoeR, Aachen

Zentrum fuer klinische Forschung Dr. med. I. Schoell, Bad Homburg

Charite Universitaetsmedizin Berlin, Berlin

Bezirkskrankenhaus Guenzburg, Günzburg

Universitaetsklinikum des Saarlandes, Homburg

Azienda Ospedaliero-Universitaria delle Marche, Ancona

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia

ASST Grande Ospedale Metropolitano Niguarda, Milan

IRCCS Ospedale San Raffaele, Milan

Fondazione IRCCS San Gerardo dei Tintori, Monza

Azienda Ospedaliero Universitaria Pisana, Pisa

Azienda Ospedaliero Universitaria Policlinico Umberto I, Roma

AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette, Torino

Pia Fondazione di Culto e Religione Cardinale Giovanni Panico, Tricase

Brain Research Center, Amsterdam

Amphia Ziekenhuis - Locatie Breda Molengracht, Breda

Brain Research Center Zwolle, Zwolle

KLIMED Marek Klimkiewicz, Bialystok

Podlaskie Centrum Psychogeriatrii, Bialystok

NEURO-CARE Sp. z o.o. Sp. Komandytowa, Katowice

Osrodek Alzheimerowski Sp. z o.o, Ścinawa

ETG Neurosciences Sp. Z.o.o., Warsaw

NZOZ Wroclawskie Centrum Alzheimerowski, Wroclaw

Ewha Womans University Mokdong Hospital, Seoul

Soonchunhyang University Hospital Cheonan, Cheonan

Yeungnam University Hospital, Daegu

Hanyang University Guri Hospital, Guri-si

Uijeongbu St. Mary's Hospital, Gyeonggi-do

Catholic Kwandong University International St.Mary's Hospital, Incheon

Eunpyeong St.Mary's Hospital, Seoul

Gangnam Severance Hospital, Yonsei University Health System, Seoul

Konkuk University Hospital, Seoul

Samsung Medical Center, Seoul

Severance Hospital, Yonsei University Health System, Seoul

Ajou University Hospital, Suwon

Fundacio ACE - Institut Catala de Neurociencies Aplicades (Alzheimer Research Center Memory Clinic), Barcelona

Hospital del Mar, Barcelona

Hospital Universitario Vall d'Hebron, Barcelona

Hospital Universitario Juan Ramon Jimenez, Huelva

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario Ramon y Cajal, Madrid

Clinica Universidad de Navarra - Pamplona, Pamplona

Hospital Clinico Universitario de Salamanca, Salamanca

Policlinica Gipuzkoa, San Sebastián

Hospital Universitari i Politecnic La Fe, Valencia

Fulbourn Hospital, Cambridge

Cornwall Partnership NHS Foundation Trust, Cornwell

Royal Devon University Healthcare NHS Foundation Trust, Exeter

NeuroClin Glasgow, Motherwell

Warneford Hospital, Oxford

Southern Health NHS Foundation Trust, Southampton

516 01

Vestra Clinics, Rychnov nad Kněžnou

00168

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, Roma

5223 LA

Brain Research Center Den Bosch, 's-Hertogenbosch

07804

Ewha Womans University Seoul Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

400-711

Inha University Hospital, Incheon

05505

Asan Medical Center, Seoul

06591

The Catholic University of Korea Seoul St.Mary's Hospital, Seoul

06973

Chung ang University Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

W12 0HS

Hammersmith Hospital, London

All Listed Sponsors
lead

AriBio Co., Ltd.

INDUSTRY

NCT05531526 - Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD) | Biotech Hunter | Biotech Hunter