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)
NCT ID: NCT05531526
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1535 participants
INTERVENTIONAL
2022-12-23
2027-12-31
Brief Summary
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Detailed Description
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AR1001 is a small molecule that has demonstrated its potential as a therapeutic agent for AD via its polypharmacological characteristics with multiple mechanisms to ameliorate AD pathology.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A - Active Comparator
Active, AR1001 30 mg QD will be administered daily for 52 weeks during the Treatment Phase of the study. In the Extension Phase, all eligible participants who choose to participate will receive AR1001 30 mg QD for 52 weeks.
AR1001
AR1001 Active Oral Tablet
Group B - Placebo Comparator
Placebo QD will be administered daily for 52 weeks during the Treatment Phase of the study. In the Extension Phase, all eligible participants who choose to participate will receive AR1001 30 mg QD for 52 weeks.
Placebo
Placebo Oral Tablet
Interventions
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AR1001
AR1001 Active Oral Tablet
Placebo
Placebo Oral Tablet
Eligibility Criteria
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Inclusion Criteria
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
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
55 Years
90 Years
ALL
Yes
Sponsors
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AriBio Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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James Rock
Role: STUDY_DIRECTOR
AriBio Co., Ltd.
Sharon Sha, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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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
Countries
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Other Identifiers
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AR1001-ADP3-US01
Identifier Type: -
Identifier Source: org_study_id
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