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AzTrials

Alzheimer DiseasePhase 3NCT05531526

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)

A Phase 3 study testing AR1001 in people with Alzheimer Disease, run by AriBio Co., Ltd. at 198 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Alzheimer Disease
What is being tested?
AR1001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,535 participants
Where
198 sitesin 13 countries
Study dates
23 Dec 2022to Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participants aged 55 to 90 years of age inclusive at the time of signing the informed consent form
  • 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
  • Participants with a history of subjective cognitive and memory decline with onset within 5 years before Screening, confirmed by study partner.
  • Participants who have a MMSE score greater than or equal to 20
  • Participants with a CDR global rating of 0.5 or 1
  • Participants with a RBANS score based on the Delayed Memory Index (DMI) score less than or equal to 85
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  • If an historic magnetic resonance imaging (MRI) is available, findings must exclude other causes of dementia.
  • Positive biomarker for brain amyloid pathology as indicated by assessment of at least one of the following:
  • 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.
  • Historical amyloid positron emission tomography (PET) assessment confirmed by the Sponsor or Designee.
  • Participants and caregiver(s) who can sign an informed consent to participate in the study.
  • Participants who have one (or more) identified adult study partner(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 able to understand the requirements of participation 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.

Who cannot join

  • Participants who are female and are either pregnant, nursing, or of childbearing potential and not practicing effective contraception
  • Participants who have signs of significant delirium which, in the opinion of the Investigator, would interfere with this study
  • 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
  • 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
  • Participants with a history of vascular dementia
  • Participants with evidence of other neurological conditions thought to interfere with the evaluations in this study
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  • Participants with a history of myocardial infarction, unstable angina, significant coronary artery disease, and/or New York Heart Association (NYHA) class III or IV heart failure within the last 12 months
  • 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
  • Participants with a body mass index (BMI) ≥35 kg/m2
  • Participants with any of the following:
  • 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)
  • deficiency (< lower limit of normal [LLN]) of Vitamin B12
  • known history of HIV (human immunodeficiency virus) positivity or positive test for HIV 1/2 at screening
  • known history of Hepatitis C virus (HCV) or positive test for HCV antibody (HCVAb) at screening (unless negative on confirmatory PCR test)'
  • positive test for Hepatitis B surface antigen (HBsAg)
  • known history of neurosyphilis or positive test for RPR at screening
  • Participants who have history of cancer or malignant tumor within 5 years prior to screening with the exception of:
  • Basal or squamous cell carcinoma of the skin or cervical dysplasia, which has been adequately treated
  • In situ Grade 1 cervical cancer, fully treated at least 2 years prior to screening, and without recurrence.
  • 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
  • Adequately treated non-metastatic breast cancer
  • Participants who in the opinion of the Investigator have an inadequately treated thyroid disorder
  • Participants with inherited degenerative retinal disease
  • 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
  • Participants who are being treated, or likely to require treatment during the study, with any medications prohibited by the study protocol
  • 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
  • Participants taking a 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.
  • Participants who have been and/or are currently being treated with anti-amyloid, anti-tau, or any investigational therapy for AD
  • Participants who currently take any other PDE-5 inhibitors (e.g., sildenafil)
  • 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)
  • Alcohol or substance use disorder within the past 5 years according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
  • Participants who have previously participated in a clinical trial with AR1001
  • Participants who, in the opinion of the Investigator, are unsuitable to participate in the trial
  • Participants who, in the opinion of the Investigator, are at significant risk of suicide.
  • GDS-15 score ≥ 8 at Screening
  • Participants requiring a lumbar puncture (LP) to verify amyloid pathology who have a contraindication to undergoing LP in the opinion of the Investigator. Participants requiring LP who are 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 or contraindicated to temporarily discontinue the therapy.

Trial locations and contacts

198 sites in 13 countries.

198 sites in 13 countries

United States75 sites

  • Dent Neuroscience Research Center

    Amherst, New York, 14226

  • Topaz Clinical Research

    Apopka, Florida, 32803

  • iResearch -Atlanta

    Atlanta, Georgia, 30030

  • Atlanta Neuroscience Institute

    Atlanta, Georgia, 30327

  • Gadolin Research LLC

    Beaumont, Texas, 77702

  • Sutter Health's Palo Alto Medical Foundation

    Burlingame, California, 94010

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718

  • Re:Cognition Health - Chicago

    Chicago, Illinois, 60611

  • BayCare Health System, Inc

    Clearwater, Florida, 33756

  • Vertex Research Group

    Clermont, Florida, 34711

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • Vaught Neurological Services, PLLC

    Crab Orchard, West Virginia, 25827

  • Kerwin Medical Center

    Dallas, Texas, 75231

  • American Clinical Research Institute, LLC

    Dayton, Ohio, 45432

  • Arrow Clinical Trial

    Daytona Beach, Florida, 32117

  • Accel Research Sites

    Decatur, Georgia, 30030

  • Denver Neurological Research

    Denver, Colorado, 80210

  • Mile High Research Center

    Denver, Colorado, 80218

  • Rhode Island Mood and Memory REsearch

    East Providence, Rhode Island, 02914

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado, 80113

  • Cognition Health Corporation

    Fairfax, Virginia, 22031

  • Integrated Neurology Services

    Falls Church, Virginia, 22043

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Cognition Health Corporation- Texas

    Houston, Texas, 77030

  • Clinical Trial Network - Houston

    Houston, Texas, 77074

  • Center for Biomedical Research, LLC - Genesis Neuroscience Clinic

    Knoxville, Tennessee, 37909

  • Wake Research- Clinical Research Center of Nevada, LLC

    Las Vegas, Nevada, 89106

  • Alivation

    Lincoln, Nebraska, 68526

  • Brainstorm Research - Loxahatchee

    Loxahatchee Groves, Florida, 33470

  • Bhupesh Dihenia, MD, PA

    Lubbock, Texas, 79410

  • ClinCloud LLC

    Maitland, Florida, 32751

  • AMC Research, LLC

    Matthews, North Carolina, 28105

  • Verus Clinical Research, Corp

    Miami, Florida, 33135

  • Vitae Research Center, LLC

    Miami, Florida, 33135

  • Caro Medcenter and Community Research

    Miami, Florida, 33145

  • Allied Biomedical Research Institute, Inc

    Miami, Florida, 33155

  • Future Life Clinical Trials

    Miami, Florida, 33169

  • Brainstorm Research

    Miami, Florida, 33176

  • Meridian International Research, Inc

    Miami Gardens, Florida, 33014

  • Esperanza Clinical

    Murrieta, California, 92562

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740

  • Tandem Clinical Research

    New Orleans, Louisiana, 70072

  • Mid-Hudson Medical Research, PLLC - New Windsor

    New Windsor, New York, 12553

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Valley Clinical Trials, INC

    Northridge, California, 91325

  • Charter Research - Orlando

    Orlando, Florida, 32803

  • K2 Medical Research

    Orlando, Florida, 32806

  • Sharlin Health Neuroscience Research Center

    Ozark, Missouri, 65721

  • JEM Research Institute

    Palm Beach, Florida, 33462

  • Havana Research Institute

    Pasadena, California, 91105

  • IMA Clinical Research Phoenix

    Phoenix, Arizona, 85012

  • Headlands Research - Eastern MA

    Plymouth, Massachusetts, 02360

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Kaizen Brain Center

    San Diego, California, 92037

  • Adaptive Research

    San Jose, California, 95124

  • The Neuron Clinic

    San Marcos, California, 92069

  • iResearch

    Savannah, Georgia, 31405

  • Perseverance Research Center, LLC

    Scottsdale, Arizona, 85253

  • Clinical Endpoints - N. Scottsdale

    Scottsdale, Arizona, 85258

  • Kingfisher Cooperative

    Spokane, Washington, 99201

  • Stanford Neuroscience Health Center

    Stanford, California, 94305

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Angels Clinical Research Institute, Inc. - Tampa

    Tampa, Florida, 33614

  • Voyage Medical

    Tempe, Arizona, 85282

  • Charter Research - The Villages

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • ClinCloud, LLC Melbourn

    Viera, Florida, 32940

  • Boston Paincare

    Waltham, Massachusetts, 02451

  • Medical College of Wisconsin

    Wauwatosa, Wisconsin, 53226

  • Accellacare of Winston-Salem, Triad Neurological Associates

    Winston-Salem, North Carolina, 27103

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

China24 sites

  • 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

Other trials in China

South Korea24 sites

  • Soonchunhyang University Hospital Cheonan

    Cheonan

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwon-do, 24253

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Yeungnam University Hospital

    Daegu

  • Hanyang University Guri Hospital

    Guri-si

  • Chonnam National University Hospital

    Gwangju, Dong-Gu, 61469

  • Uijeongbu St. Mary's Hospital

    Gyeonggi-do

  • Gachon University Gil Medical Center

    Incheon, Namdong-Gu, 21565

  • Inha University Hospital

    Incheon, 400-711

  • Catholic Kwandong University International St.Mary's Hospital

    Incheon

  • Seoul National University Bundang Hospital

    Seongnam-si, Bundang-gu, 13620

  • Ewha Womans University Seoul Hospital

    Seoul, Gangseo-gu, 07804

  • Severance Hospital, Yonsei University Health System

    Seoul, Seodaemun-gu, 03722

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul

  • Asan Medical Center

    Seoul, 05505

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

    Seoul, 06591

  • Chung ang University Hospital

    Seoul, 06973

  • Korea University Guro Hospital

    Seoul, 08308

  • 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

Other trials in South Korea

Spain11 sites

  • 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 Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia

Other trials in Spain

Canada10 sites

  • 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

Other trials in Canada

France10 sites

  • 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 Rennes - Hopital Pontchaillou

    Rennes, 35033

  • CHRU de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67200

  • CHU de Toulouse - Hopital La Grave

    Toulouse

  • HCL - Hopital des Charpennes

    Villeurbanne

Other trials in France

Italy10 sites

  • 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

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

    Roma, 00168

  • 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

Other trials in Italy

Czechia8 sites

  • 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

  • Vestra Clinics

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

United Kingdom7 sites

  • Fulbourn Hospital

    Cambridge

  • Cornwall Partnership NHS Foundation Trust

    Cornwell

  • Royal Devon University Healthcare NHS Foundation Trust

    Exeter

  • Hammersmith Hospital

    London, W12 0HS

  • NeuroClin Glasgow

    Motherwell

  • Warneford Hospital

    Oxford

  • Southern Health NHS Foundation Trust

    Southampton

Other trials in United Kingdom

Germany6 sites

  • 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

  • Institut fuer Studien zur Psychischen Gesundheit (ISPG)

    Mannheim, 68165

Other trials in Germany

Poland6 sites

  • 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

Other trials in Poland

Netherlands4 sites

  • Brain Research Center Den Bosch

    's-Hertogenbosch, 5223 LA

  • Brain Research Center

    Amsterdam

  • Amphia Ziekenhuis - Locatie Breda Molengracht

    Breda

  • Brain Research Center Zwolle

    Zwolle

Other trials in Netherlands

Denmark3 sites

  • Sanos Clinic - Gandrup

    Gandrup, 9362

  • Sanos Clinic - Herlev

    Herlev

  • Sanos Clinic Syddanmark - Vejle

    Vejle

Other trials in Denmark

About this study

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)

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.

Read the detailed description

The purpose of this Study is to evaluate the efficacy and safety of AR1001 in participants with Early Alzheimer's Disease (AD).

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.

Being tested
AR1001, Placebo
Keywords
AR1001, AD, Early AD, Alzheimer's disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AR1001Drug

    AR1001 Active Oral Tablet

  • PlaceboDrug

    Placebo Oral Tablet

Study groups in NCT05531526
Study groupRoleWhat they receive
Group A - Active ComparatorActive comparatorActive, 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.
Receives: Drug: AR1001
Group B - Placebo ComparatorPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Overall Population)

    CDR-SB is used to assess clinical decline associated with AD. The CDR is a 5-point scale used to stage AD by characterization of the 6 domains of cognitive and functional performance: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. This information is collected through a semi structured interview of the participant and the informant. Scores range from 0 to 3 (0, 0.5, 1, 2, 3), with a higher score indicating greater impairment. The CDR-SB score is obtained by summing each of the CDR domain box scores, with scores ranging from 0 to 18.

    Measured: Baseline to Week 52

  2. Change from Baseline in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Monotherapy Population)

    CDR-SB is used to assess clinical decline associated with AD. The CDR is a 5-point scale used to stage AD by characterization of the 6 domains of cognitive and functional performance: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. This information is collected through a semi structured interview of the participant and the informant. Scores range from 0 to 3 (0, 0.5, 1, 2, 3), with a higher score indicating greater impairment. The CDR-SB score is obtained by summing each of the CDR domain box scores, with scores ranging from 0 to 18.

    The monotherapy population is a subset of the overall population that is not taking concomitant medication for AD during the trial.

    Measured: Baseline to Week 52

Secondary outcomes (8)

  1. Change from Baseline in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-Cog 13) (Overall Population)

    ADAS-Cog13 is a clinician-administered assessment of cognitive function in individuals with Alzheimer's disease that evaluates domains including memory, language, praxis, orientation, attention, and concentration. Total scores range from 0 to 85, with higher scores indicating greater cognitive impairment.

    Measured: Baseline to Week 52

  2. Change from Baseline in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-Cog 13) (Monotherapy Population)

    ADAS-Cog13 is a clinician-administered assessment of cognitive function in individuals with Alzheimer's disease that evaluates domains including memory, language, praxis, orientation, attention, and concentration. Total scores range from 0 to 85, with higher scores indicating greater cognitive impairment. The monotherapy population is a subset of the overall population that is not taking concomitant AD medication.

    Measured: Baseline to Week 52

  3. Change from Baseline in the Amsterdam-Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV) (Overall Population)

    The A-IADL-Q is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in early dementia. The questionnaire is completed by a caregiver. Higher scores indicate better everyday functioning

    Measured: Baseline to Week 52

  4. Change from Baseline in the Amsterdam-Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV) (Monotherapy Population)

    The A-IADL-Q is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in early dementia. The questionnaire is completed by a caregiver. Higher scores indicate better everyday functioning. The monotherapy population is a subset of the overall population that is not taking concomitant medication for AD during the trial.

    Measured: Baseline to Week 52

  5. Change from Baseline in the Geriatric Depression Scale-15 (GDS-15) (Overall Population)

    The GDS-15 assesses depressive symptoms using 15 items. Scores range from 0 to 15, with higher scores indicating more depressive symptoms.

    Measured: Baseline to Week 52

  6. Change from Baseline in the Geriatric Depression Scale-15 (GDS-15) (Monotherapy Population)

    The GDS-15 is a validated 15-item self-report questionnaire used to screen for depressive symptoms in older adults. Total scores range from 0 to 15, with higher scores indicating greater depressive symptom severity. The monotherapy population is a subset of the overall population that is not taking concomitant medication for AD during the trial.

    Measured: Baseline to Week 52

  7. Change from Baseline in the Mini-Mental Status Examination (MMSE) (Overall Population)

    The MMSE is a clinician-administered assessment of global cognitive function that evaluates orientation, attention, memory, language, and visuospatial abilities. Total scores range from 0 to 30, with lower scores indicating greater cognitive impairment.

    Measured: Baseline to Week 52

  8. Change from Baseline in the Mini-Mental Status Examination (MMSE) (Monotherapy Population)

    The MMSE is a clinician-administered assessment of global cognitive function that evaluates orientation, attention, memory, language, and visuospatial abilities. Total scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The monotherapy population is a subset of the overall population that is not taking concomitant medication for AD during the trial.

    Measured: Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start23 Dec 2022
  3. Primary completion29 Jun 2026
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531526
Sponsor's protocol ID
AR1001-ADP3-US01
Status last verified
Oct 2026
First submitted
31 Aug 2022
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AR1001 in people with Alzheimer Disease, run by AriBio Co., Ltd. at 198 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in United States, China, South Korea, Spain, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Overall Population) (time frame: Baseline to Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05531526.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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