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ACTIVE NOT RECRUITING

NCT05531526

PHASE3

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)

Sponsor: AriBio Co., Ltd.

View on ClinicalTrials.gov

Summary

This AR1001-ADP3-US01 protocol is a double-blind, randomized, placebo-controlled, multi- center, parallel-group comparison pivotal Phase 3 study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early AD.

Official title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 Over 52 Weeks in Participants With Early Alzheimer's Disease (Polaris-AD)

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1535

Start Date

2022-12-23

Completion Date

2027-12

Last Updated

2025-10-02

Healthy Volunteers

Yes

Conditions

Alzheimer Disease

Interventions

DRUG

AR1001

AR1001 Active Oral Tablet

DRUG

Placebo

Placebo Oral Tablet

Inclusion Criteria: 1. Male or female participants aged 55 to 90 years of age inclusive at the time of signing the informed consent form 2. Mild cognitive impairment or mild dementia consistent with AD defined by stages 3 to 4 according to the National Institute on Aging and Alzheimer's Association (NIA-AA) at Screening 3. Participants with a history of subjective cognitive and memory decline with onset within 5 years before Screening, confirmed by study partner. 4. Participants who have a MMSE score greater than or equal to 20 5. Participants with a CDR global rating of 0.5 or 1 6. Participants with a RBANS score based on the Delayed Memory Index (DMI) score less than or equal to 85 7. If an historic magnetic resonance imaging (MRI) is available, findings must exclude other causes of dementia. 8. Positive biomarker for brain amyloid pathology as indicated by assessment of at least one of the following: 1. Current or historical CSF assessment with FDA-cleared assays, including Lumipulse® beta-amyloid ratio \[1-42/1-40\] ≤ 0.072, Elecsys® pTau 181/Aβ\[1-42\] greater than 0.023, Elecsys® tTau /Aβ\[1-42\] greater than 0.28, or other assays or cut-offs as they become FDA-cleared. 2. Historical amyloid positron emission tomography (PET) assessment confirmed by the Sponsor or Designee. 9. Participants (or participant's legally authorized representative) and caregiver (s) who can sign an informed consent to participate in the study. 10. Participants who have one (or more) identified adult study partners (s) who, in the opinion of the Investigator, has sufficient contact with and knowledge about the participant as to be able to report knowledgably about the participant's cognition, function, behavior, and safety, and compliance with the protocol. The informant/care partner must be available by phone to provide information to the Investigator and study staff about the participant as well as agree to attend in-person clinic visits that require partner input for scale completion. The informant/care partner must be literate and provide informed consent and should be available for the duration of the study. The same informant/care partner is required to be consistent across all study visits except under rare, unavoidable circumstances (e.g., unexpected informant health crisis) that are approved by the Investigator and Sponsor. Exclusion Criteria: 1. Participants who are female and are either pregnant, nursing, or of childbearing potential and not practicing effective contraception 2. Participants who have signs of significant delirium which, in the opinion of the Investigator, would interfere with this study 3. Participants who have any diagnosis of dementia or cognitive decline other than that related to AD, including, but not limited to concomitant history of significant head trauma, alcohol abuse, frontotemporal dementia, Huntington Disease, Parkinsonism (e.g., Parkinson's disease, Dementia with Lewy Bodies, etc.), significant cerebrovascular disease, and/or significant seizure disorder 4. Participants with any current psychiatric diagnosis if, in the judgment of the Investigator, the psychiatric disorder (e.g., schizophrenia) or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant's ability to complete the study 5. Participants with a history of vascular dementia 6. Participants with evidence of other neurological conditions thought to interfere with the evaluations in this study 7. Participants with a history of myocardial infarction, unstable angina, coronary artery disease, and/or New York Heart Association (NYHA) class III or IV heart failure within the last 12 months 8. Participants with uncontrolled hypertension (systolic blood pressure (BP) \>160 mmHg or diastolic BP \> 95 mmHg) or hypotension (systolic BP \<90 mmHg or diastolic BP \<50 mmHg). Participants may undergo repeated testing to ensure that accurate BP readings are obtained 9. Participants with a body mass index (BMI) \> 35 kg/m2 10. Participants with any of the following: 1. elevation (\>2.5x upper limit of normal \[ULN\]) of AST (aspartate aminotransferase, ALT (alanine transaminase, or total bilirubin (unless known prior history of Gilbert's syndrome) 2. deficiency (\< lower limit of normal \[LLN\]) of Vitamin B12 3. known history of HIV (human immunodeficiency virus) positivity or positive test for HIV 1/2 at screening 4. known history of Hepatitis C virus (HCV) or positive test for HCV antibody (HCVAb) at screening (unless negative on confirmatory PCR test)' 5. positive test for Hepatitis B surface antigen (HBsAg) 6. known history of neurosyphilis or positive test for RPR at screening 11. Participants who have history of cancer or malignant tumor within 5 years prior to screening with the exception of: 1. Basal or squamous cell carcinoma of the skin or cervical dysplasia, which has been adequately treated 2. In situ Grade 1 cervical cancer, fully treated at least 2 years prior to screening, and without recurrence. 3. Prostate cancer, confined to the prostate gland, which has been adequately treated (e.g., surgery and/or radiation or watchful waiting) with normal or low and stable prostate-specific antigen (PSA) levels for 2 years prior to Screening 4. Adequately treated non-metastatic breast cancer 12. Participants who in the opinion of the Investigator have an inadequately treated thyroid disorder 13. Participants with inherited degenerative retinal disease 14. Participants who have an undiagnosed or uncontrolled seizure disorder (and/or an epileptic syndrome), which has or could lead to cognitive impairment either from repeated seizures or the medications used to control the seizure disorder 15. Participants who are being treated, or likely to require treatment during the study, with any medications prohibited by the study protocol 16. Participants who have participated in any investigational drug or device trial within the previous 30 days or five half-lives of an investigational drug at Screening, whichever is longer 17. Participants taking an oral cholinesterase inhibitor and/or memantine not on a stable dose for at least 3 months prior to screening. Treatment and dosing should remain stable, with no changes throughout the trial. 18. Participants who have been and/or are currently being treated with anti-amyloid, anti-tau, or any other investigational therapies for AD 19. Participants who currently take any other PDE-5 Inhibitors (e.g., sildenafil) 20. Participants who are currently receiving (or unable to stop use for at least 14 days \[2 weeks\] prior to receiving the first dose of the AR1001 and throughout the study) prescription or nonprescription medications or other products known to be potent inhibitors of cytochrome P450 isozyme 3A4 (CYP3A4) 21. Alcohol or substance use disorder within the past 5 years according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) 22. Participants who have previously participated in a clinical trial with AR1001 23. Participants, in the opinion of the Investigator, who are unsuitable to participate in the trial 24. Participants who in the opinion of the Investigator are at significant risk of suicide. 25. GDS-15 score greater than equal to 8 at Screening 26. Participants, in the opinion of the Investigator, who have any who have any contraindications to undergoing LP. Participants receiving ongoing anticoagulant therapy or antiplatelet therapy (other than aspirin and non-steroidal anti-inflammatory drugs \[NSAIDs\]) should also be excluded if it is considered unsafe to temporarily discontinue the therapy

Locations (198)

IMA Clinical Research Phoenix

Phoenix, Arizona, United States

Perseverance Research Center, LLC

Scottsdale, Arizona, United States

Clinical Endpoints - N. Scottsdale

Scottsdale, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Voyage Medical

Tempe, Arizona, United States

Sutter Health's Palo Alto Medical Foundation

Burlingame, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

Fullerton Neurology and Headache Center

Fullerton, California, United States

Esperanza Clinical

Murrieta, California, United States

Valley Clinical Trials, INC

Northridge, California, United States

Havana Research Institute

Pasadena, California, United States

Kaizen Brain Center

San Diego, California, United States

Adaptive Research

San Jose, California, United States

The Neuron Clinic

San Marcos, California, United States

Stanford Neuroscience Health Center

Stanford, California, United States

Denver Neurological Research

Denver, Colorado, United States

Mile High Research Center

Denver, Colorado, United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, United States

Topaz Clinical Research

Apopka, Florida, United States

BayCare Health System, Inc

Clearwater, Florida, United States

Vertex Research Group

Clermont, Florida, United States

Arrow Clinical Trial

Daytona Beach, Florida, United States

Brainstorm Research - Loxahatchee

Loxahatchee Groves, Florida, United States

ClinCloud LLC

Maitland, Florida, United States

Verus Clinical Research, Corp

Miami, Florida, United States

Vitae Research Center, LLC

Miami, Florida, United States

Caro Medcenter and Community Research

Miami, Florida, United States

Allied Biomedical Research Institute, Inc

Miami, Florida, United States

Future Life Clinical Trials

Miami, Florida, United States

Brainstorm Research

Miami, Florida, United States

Meridian International Research, Inc

Miami Gardens, Florida, United States

Charter Research - Orlando

Orlando, Florida, United States

K2 Medical Research

Orlando, Florida, United States

JEM Research Institute

Palm Beach, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Angels Clinical Research Institute, Inc. - Tampa

Tampa, Florida, United States

Charter Research - The Villages

The Villages, Florida, United States

ClinCloud, LLC Melbourn

Viera, Florida, United States

Conquest Research

Winter Park, Florida, United States

iResearch -Atlanta

Atlanta, Georgia, United States

Atlanta Neuroscience Institute

Atlanta, Georgia, United States

Accel Research Sites

Decatur, Georgia, United States

iResearch

Savannah, Georgia, United States

Re:Cognition Health - Chicago

Chicago, Illinois, United States

Tandem Clinical Research

New Orleans, Louisiana, United States

BTC of New Bedford

New Bedford, Massachusetts, United States

Boston Center for Memory

Newton, Massachusetts, United States

Headlands Research - Eastern MA

Plymouth, Massachusetts, United States

Boston Paincare

Waltham, Massachusetts, United States

Sharlin Health Neuroscience Research Center

Ozark, Missouri, United States

Alivation

Lincoln, Nebraska, United States

Wake Research- Clinical Research Center of Nevada, LLC

Las Vegas, Nevada, United States

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States

Dent Neuroscience Research Center

Amherst, New York, United States

Mid-Hudson Medical Research, PLLC - New Windsor

New Windsor, New York, United States

Triad Clinical Trials

Greensboro, North Carolina, United States

AMC Research, LLC

Matthews, North Carolina, United States

Accellacare of Winston-Salem, Triad Neurological Associates

Winston-Salem, North Carolina, United States

NeuroScience Research Center, LLC

Canton, Ohio, United States

American Clinical Research Institute, LLC

Dayton, Ohio, United States

Rhode Island Mood and Memory REsearch

East Providence, Rhode Island, United States

Health Concepts

Rapid City, South Dakota, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Center for Biomedical Research, LLC - Genesis Neuroscience Clinic

Knoxville, Tennessee, United States

Gadolin Research LLC

Beaumont, Texas, United States

Kerwin Medical Center

Dallas, Texas, United States

Cognition Health Corporation- Texas

Houston, Texas, United States

Clinical Trial Network - Houston

Houston, Texas, United States

Bhupesh Dihenia, MD, PA

Lubbock, Texas, United States

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States

Cognition Health Corporation

Fairfax, Virginia, United States

Integrated Neurology Services

Falls Church, Virginia, United States

Kingfisher Cooperative

Spokane, Washington, United States

Vaught Neurological Services, PLLC

Crab Orchard, West Virginia, United States

Medical College of Wisconsin

Wauwatosa, Wisconsin, United States

Centricity Research - Halifax

Halifax, Canada

Okanagan Clinical Trials

Kelowna, Canada

Parkwood Institute

London, Canada

Baycrest Academy for Research and Education

North York, Canada

Kawartha Centre - Redefining Healthy Aging

Peterborough, Canada

Centricity Research

Toronto, Canada

Sunnybrook Health Sciences Centre

Toronto, Canada

University Health Network-Toronto Western Hospital

Toronto, Canada

Royal Jubilee Hospital

Victoria, Canada

Medical Arts Health Research Group - West Vancouver

West Vancouver, Canada

Beijing Anding Hospital Capital Medical University

Beijing, China

Beijing Friendship Hospital,Capital Medical University

Beijing, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Peking University Sixth Hospital

Beijing, China

Xuanwu Hospital Capital Medical University

Beijing, China

The First Hospital of Jilin University

Changchun, China

Xiangya Hospital of Central South University

Changsha, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Guangdong Provincial People's Hospital

Guangzhou, China

The Affiliated Brain Hospital Of Guangzhou Medical University

Guangzhou, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Anhui Provincial Hospital

Hefei, China

Tianjin Medical University General Hospital

Heping, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Huashan Hospital affiliated to Fudan University

Shanghai, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

The First Hospital of Hebei Medical University

Shijiazhuang, China

The First Affiliated Hospital of Soochow University

Suzhou, China

The Second Affiliated Hospital of Soochow University

Suzhou, China

Tongji Hospital Of Tongji University

Wuhan, China

Xuzhou Central Hospital

Xuzhou, China

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

NeuroHK s.r.o.

Choceň, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

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

Pilsen, Czechia

FORBELI s.r.o

Prague, Czechia

INEP Medical s.r.o.

Prague, Czechia

Neuropsychiatrie s.r.o.

Prague, Czechia

Vestra Clinics

Rychnov nad Kněžnou, Czechia

Sanos Clinic - Gandrup

Gandrup, Denmark

Sanos Clinic - Herlev

Herlev, Denmark

Sanos Clinic Syddanmark - Vejle

Vejle, Denmark

CHU de Lille - Hopital Roger Salengro

Lille, France

AP-HM - Hopital de la Timone

Marseille, France

CHU de Nantes - Hopital Nord Laennec

Nantes, France

AP-HP Hopital Broca

Paris, France

AP-HP Hopital Lariboisiere

Paris, France

AP-HP Hopital Pitie-Salpetriere

Paris, France

CHU Rennes - Hopital Pontchaillou

Rennes, France

CHRU de Strasbourg - Hopital de Hautepierre

Strasbourg, France

CHU de Toulouse - Hopital La Grave

Toulouse, France

HCL - Hopital des Charpennes

Villeurbanne, France

Universitaetsklinikum Aachen, AoeR

Aachen, Germany

Zentrum fuer klinische Forschung Dr. med. I. Schoell

Bad Homburg, Germany

Charite Universitaetsmedizin Berlin

Berlin, Germany

Bezirkskrankenhaus Guenzburg

Günzburg, Germany

Universitaetsklinikum des Saarlandes

Homburg, Germany

Institut fuer Studien zur Psychischen Gesundheit (ISPG)

Mannheim, Germany

Azienda Ospedaliero-Universitaria delle Marche

Ancona, Italy

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

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

Roma, Italy

Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, Italy

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

Torino, Italy

Pia Fondazione di Culto e Religione Cardinale Giovanni Panico

Tricase, Italy

Brain Research Center Den Bosch

's-Hertogenbosch, Netherlands

Brain Research Center

Amsterdam, Netherlands

Amphia Ziekenhuis - Locatie Breda Molengracht

Breda, Netherlands

Brain Research Center Zwolle

Zwolle, Netherlands

KLIMED Marek Klimkiewicz

Bialystok, Poland

Podlaskie Centrum Psychogeriatrii

Bialystok, Poland

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

Katowice, Poland

Osrodek Alzheimerowski Sp. z o.o

Ścinawa, Poland

ETG Neurosciences Sp. Z.o.o.

Warsaw, Poland

NZOZ Wroclawskie Centrum Alzheimerowski

Wroclaw, Poland

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, South Korea

Chonnam National University Hospital

Gwangju, Dong-Gu, South Korea

Ewha Womans University Seoul Hospital

Seoul, Gangseo-gu, South Korea

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Gachon University Gil Medical Center

Incheon, Namdong-Gu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seodaemun-gu, South Korea

Ewha Womans University Mokdong Hospital

Seoul, Seoul, South Korea

Soonchunhyang University Hospital Cheonan

Cheonan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Yeungnam University Hospital

Daegu, South Korea

Hanyang University Guri Hospital

Guri-si, South Korea

Uijeongbu St. Mary's Hospital

Gyeonggi-do, South Korea

Inha University Hospital

Incheon, South Korea

Catholic Kwandong University International St.Mary's Hospital

Incheon, South Korea

Asan Medical Center

Seoul, South Korea

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

Seoul, South Korea

Chung ang University Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Eunpyeong St.Mary's Hospital

Seoul, South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea

Konkuk University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

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

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Policlinica Gipuzkoa

San Sebastián, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Fulbourn Hospital

Cambridge, United Kingdom

Cornwall Partnership NHS Foundation Trust

Cornwell, United Kingdom

Royal Devon University Healthcare NHS Foundation Trust

Exeter, United Kingdom

Hammersmith Hospital

London, United Kingdom

NeuroClin Glasgow

Motherwell, United Kingdom

Warneford Hospital

Oxford, United Kingdom

Southern Health NHS Foundation Trust

Southampton, United Kingdom

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (198)