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New pill could slow Alzheimer's: major trial underway

NCT ID NCT05531526

Disease control Sponsor: AriBio Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called AR1001 in people with early Alzheimer's disease. About 1,535 participants will take either the drug or a placebo for 52 weeks to see if it slows memory and thinking decline. The goal is to control the disease, not cure it, and researchers will monitor safety and daily living skills.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,535 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

  • AMC Research, LLC

    Matthews, North Carolina, 28105, United States

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

    Torino, Italy

  • AP-HM - Hopital de la Timone

    Marseille, France

  • AP-HP Hopital Broca

    Paris, France

  • AP-HP Hopital Lariboisiere

    Paris, France

  • AP-HP Hopital Pitie-Salpetriere

    Paris, France

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • Accel Research Sites

    Decatur, Georgia, 30030, United States

  • Accellacare of Winston-Salem, Triad Neurological Associates

    Winston-Salem, North Carolina, 27103, United States

  • Adaptive Research

    San Jose, California, 95124, United States

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755, United States

  • Ajou University Hospital

    Suwon, South Korea

  • Alivation

    Lincoln, Nebraska, 68526, United States

  • Allied Biomedical Research Institute, Inc

    Miami, Florida, 33155, United States

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

    Pilsen, Czechia

  • American Clinical Research Institute, LLC

    Dayton, Ohio, 45432, United States

  • Amphia Ziekenhuis - Locatie Breda Molengracht

    Breda, Netherlands

  • Angels Clinical Research Institute, Inc. - Tampa

    Tampa, Florida, 33614, United States

  • Anhui Provincial Hospital

    Hefei, China

  • Arrow Clinical Trial

    Daytona Beach, Florida, 32117, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Atlanta Neuroscience Institute

    Atlanta, Georgia, 30327, United States

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Italy

  • Azienda Ospedaliero Universitaria Policlinico Umberto I

    Roma, Italy

  • Azienda Ospedaliero-Universitaria delle Marche

    Ancona, Italy

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • BayCare Health System, Inc

    Clearwater, Florida, 33756, United States

  • Baycrest Academy for Research and Education

    North York, 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

  • Bezirkskrankenhaus Guenzburg

    Günzburg, Germany

  • Bhupesh Dihenia, MD, PA

    Lubbock, Texas, 79410, United States

  • Boston Center for Memory

    Newton, Massachusetts, 02459, United States

  • Boston Paincare

    Waltham, Massachusetts, 02451, United States

  • Brain Research Center

    Amsterdam, Netherlands

  • Brain Research Center Den Bosch

    's-Hertogenbosch, 5223 LA, Netherlands

  • Brain Research Center Zwolle

    Zwolle, Netherlands

  • Brainstorm Research

    Miami, Florida, 33176, United States

  • Brainstorm Research - Loxahatchee

    Loxahatchee Groves, Florida, 33470, United States

  • CHRU de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67200, France

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033, France

  • CHU de Lille - Hopital Roger Salengro

    Lille, France

  • CHU de Nantes - Hopital Nord Laennec

    Nantes, France

  • CHU de Toulouse - Hopital La Grave

    Toulouse, France

  • Caro Medcenter and Community Research

    Miami, Florida, 33145, United States

  • Catholic Kwandong University International St.Mary's Hospital

    Incheon, South Korea

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado, 80113, United States

  • Center for Biomedical Research, LLC - Genesis Neuroscience Clinic

    Knoxville, Tennessee, 37909, United States

  • Centricity Research

    Toronto, Canada

  • Centricity Research - Halifax

    Halifax, Canada

  • Charite Universitaetsmedizin Berlin

    Berlin, Germany

  • Charter Research - Orlando

    Orlando, Florida, 32803, United States

  • Charter Research - The Villages

    The Villages, Florida, 32162, United States

  • Chonnam National University Hospital

    Gwangju, Dong-Gu, 61469, South Korea

  • Chung ang University Hospital

    Seoul, 06973, South Korea

  • ClinCloud LLC

    Maitland, Florida, 32751, United States

  • ClinCloud, LLC Melbourn

    Viera, Florida, 32940, United States

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, Spain

  • Clinical Endpoints - N. Scottsdale

    Scottsdale, Arizona, 85258, United States

  • Clinical Trial Network - Houston

    Houston, Texas, 77074, United States

  • Cognition Health Corporation

    Fairfax, Virginia, 22031, United States

  • Cognition Health Corporation- Texas

    Houston, Texas, 77030, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • Cornwall Partnership NHS Foundation Trust

    Cornwell, United Kingdom

  • Dent Neuroscience Research Center

    Amherst, New York, 14226, United States

  • Denver Neurological Research

    Denver, Colorado, 80210, United States

  • ETG Neurosciences Sp. Z.o.o.

    Warsaw, Poland

  • Esperanza Clinical

    Murrieta, California, 92562, United States

  • Eunpyeong St.Mary's Hospital

    Seoul, South Korea

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul, South Korea

  • Ewha Womans University Seoul Hospital

    Seoul, Gangseo-gu, 07804, South Korea

  • FORBELI s.r.o

    Prague, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Czechia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, Czechia

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Italy

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

    Roma, 00168, Italy

  • Fulbourn Hospital

    Cambridge, United Kingdom

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835, United States

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

    Barcelona, Spain

  • Future Life Clinical Trials

    Miami, Florida, 33169, United States

  • Gachon University Gil Medical Center

    Incheon, Namdong-Gu, 21565, South Korea

  • Gadolin Research LLC

    Beaumont, Texas, 77702, United States

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • HCL - Hopital des Charpennes

    Villeurbanne, France

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwon-do, 24253, South Korea

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Hanyang University Guri Hospital

    Guri-si, South Korea

  • Havana Research Institute

    Pasadena, California, 91105, United States

  • Headlands Research - Eastern MA

    Plymouth, Massachusetts, 02360, United States

  • Health Concepts

    Rapid City, South Dakota, 57702, United States

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Huashan Hospital affiliated to Fudan University

    Shanghai, China

  • IMA Clinical Research Phoenix

    Phoenix, Arizona, 85012, United States

  • INEP Medical s.r.o.

    Prague, Czechia

  • IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

    Brescia, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Italy

  • Inha University Hospital

    Incheon, 400-711, South Korea

  • Institut fuer Studien zur Psychischen Gesundheit (ISPG)

    Mannheim, 68165, Germany

  • Integrated Neurology Services

    Falls Church, Virginia, 22043, United States

  • JEM Research Institute

    Palm Beach, Florida, 33462, United States

  • K2 Medical Research

    Orlando, Florida, 32806, United States

  • KLIMED Marek Klimkiewicz

    Bialystok, Poland

  • Kaizen Brain Center

    San Diego, California, 92037, United States

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Canada

  • Kerwin Medical Center

    Dallas, Texas, 75231, United States

  • Kingfisher Cooperative

    Spokane, Washington, 99201, United States

  • Konkuk University Hospital

    Seoul, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Medical Arts Health Research Group - West Vancouver

    West Vancouver, Canada

  • Medical College of Wisconsin

    Wauwatosa, Wisconsin, 53226, United States

  • Meridian International Research, Inc

    Miami Gardens, Florida, 33014, United States

  • Mid-Hudson Medical Research, PLLC - New Windsor

    New Windsor, New York, 12553, United States

  • Mile High Research Center

    Denver, Colorado, 80218, United States

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

    Katowice, Poland

  • NZOZ Wroclawskie Centrum Alzheimerowski

    Wroclaw, Poland

  • Nanjing Drum Tower Hospital

    Nanjing, China

  • Neuro-Pain Medical Center

    Fresno, California, 93710, United States

  • NeuroClin Glasgow

    Motherwell, United Kingdom

  • NeuroHK s.r.o.

    Choceň, Czechia

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718, United States

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018, United States

  • Neuropsychiatrie s.r.o.

    Prague, Czechia

  • Okanagan Clinical Trials

    Kelowna, Canada

  • Osrodek Alzheimerowski Sp. z o.o

    Ścinawa, Poland

  • Parkwood Institute

    London, Canada

  • Peking Union Medical College Hospital

    Beijing, China

  • Peking University Sixth Hospital

    Beijing, China

  • Perseverance Research Center, LLC

    Scottsdale, Arizona, 85253, United States

  • Pia Fondazione di Culto e Religione Cardinale Giovanni Panico

    Tricase, Italy

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, Poland

  • Policlinica Gipuzkoa

    San Sebastián, Spain

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • Re:Cognition Health - Chicago

    Chicago, Illinois, 60611, United States

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, China

  • Rhode Island Mood and Memory REsearch

    East Providence, Rhode Island, 02914, United States

  • Royal Devon University Healthcare NHS Foundation Trust

    Exeter, United Kingdom

  • Royal Jubilee Hospital

    Victoria, Canada

  • Samsung Medical Center

    Seoul, South Korea

  • Sanos Clinic - Gandrup

    Gandrup, 9362, Denmark

  • Sanos Clinic - Herlev

    Herlev, Denmark

  • Sanos Clinic Syddanmark - Vejle

    Vejle, Denmark

  • Seoul National University Bundang Hospital

    Seongnam-si, Bundang-gu, 13620, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seodaemun-gu, 03722, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Sharlin Health Neuroscience Research Center

    Ozark, Missouri, 65721, United States

  • Soonchunhyang University Hospital Cheonan

    Cheonan, South Korea

  • Southern Health NHS Foundation Trust

    Southampton, United Kingdom

  • Stanford Neuroscience Health Center

    Stanford, California, 94305, United States

  • Sunnybrook Health Sciences Centre

    Toronto, Canada

  • Sutter Health's Palo Alto Medical Foundation

    Burlingame, California, 94010, United States

  • Tandem Clinical Research

    New Orleans, Louisiana, 70072, United States

  • The Affiliated Brain Hospital Of Guangzhou Medical University

    Guangzhou, China

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

    Seoul, 06591, South Korea

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, China

  • The First Hospital of Jilin University

    Changchun, China

  • The Neuron Clinic

    San Marcos, California, 92069, United States

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, China

  • Tianjin Medical University General Hospital

    Heping, China

  • Tongji Hospital Of Tongji University

    Wuhan, China

  • Topaz Clinical Research

    Apopka, Florida, 32803, United States

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410, United States

  • Uijeongbu St. Mary's Hospital

    Gyeonggi-do, South Korea

  • Universitaetsklinikum Aachen, AoeR

    Aachen, Germany

  • Universitaetsklinikum des Saarlandes

    Homburg, Germany

  • University Health Network-Toronto Western Hospital

    Toronto, Canada

  • Valley Clinical Trials, INC

    Northridge, California, 91325, United States

  • Vaught Neurological Services, PLLC

    Crab Orchard, West Virginia, 25827, United States

  • Vertex Research Group

    Clermont, Florida, 34711, United States

  • Verus Clinical Research, Corp

    Miami, Florida, 33135, United States

  • Vestra Clinics

    Rychnov nad Kněžnou, 516 01, Czechia

  • Vitae Research Center, LLC

    Miami, Florida, 33135, United States

  • Voyage Medical

    Tempe, Arizona, 85282, United States

  • Wake Research- Clinical Research Center of Nevada, LLC

    Las Vegas, Nevada, 89106, United States

  • Warneford Hospital

    Oxford, United Kingdom

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107, United States

  • Xiangya Hospital of Central South University

    Changsha, China

  • Xuanwu Hospital Capital Medical University

    Beijing, China

  • Xuzhou Central Hospital

    Xuzhou, China

  • Yeungnam University Hospital

    Daegu, South Korea

  • Zentrum fuer klinische Forschung Dr. med. I. Schoell

    Bad Homburg, Germany

  • iResearch

    Savannah, Georgia, 31405, United States

  • iResearch -Atlanta

    Atlanta, Georgia, 30030, United States

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