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New Alzheimer's drug shows promise in Mid-Stage trial

NCT ID NCT06881836

Disease control Sponsor: Ono Pharmaceutical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 2 times

Summary

This study tests a new medicine called ONO-2020 in 240 people with mild to moderate Alzheimer's disease. The goal is to see if it can safely improve memory and thinking skills. Participants will receive either the drug or a placebo for 26 weeks, and researchers will track side effects and cognitive changes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

260 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Sep 2026

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 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Have a diagnosis of Alzheimer's disease according to the recommendations from the revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup , along with any positive AD-specific biomarker results (abnormal Core 1 or Core 2 biomarkers) from a previous diagnosis or at screening. 2. Have a previous MRI or CT scan of the brain, which was performed within 1 year prior to enrollment in the study, to confirm that more recent neurological events (e.g., stroke) would not potentially constitute a confounder in the assessment of the etiology of the participant's cognitive status. 3. MMSE score of 15 to 24, inclusive, and MMSE score cannot deviate more than 3 points in either direction between the screening and baseline visits. 4. AD numeric clinical stage 4 or stage 5 based on NIA-AA criteria 2024, at screening and baseline visits 5. Participants receiving concurrent AD treatment (acetylcholinesterase inhibitors and /or memantine) must be on a stable dose for at least 90 days prior to randomization, and the participant must be willing to remain on the same dose for the duration of the study. 6. Have the ability to comply with procedures for cognitive and other tests in the opinion of the investigator 7. If female, postmenopausal for at least 1 year 8. Non-vasectomized male participants with female partners of childbearing potential must agree to use an effective method of contraception from dosing on Day 1 until 3 months after the last administration of study intervention and agree not to donate sperm until 3 months after the last administration of study intervention. 9. Participant must have a Caregiver who has frequent contact with the participant (defined as at least 8 hours per week spread across 3\~4 visits per week) to provide support to the participant to ensure compliance with study requirements. The Caregiver must be willing to consent to participate in this study, to provide a rating of the extent and severity of change of the participant's memory, problem-solving abilities, or activities of daily living from prior abilities. 10. General health status acceptable for participation in the study, and the participant must be able to ingest pills. 11. Participant and his/her Caregiver have provided full written informed consent prior to the performance of any protocol-specified procedure; or if a participant is unable to provide informed consent due to cognitive status, he/she has provided assent, and a legally acceptable representative (LAR) has provided full written informed consent on behalf of the participant. Exclusion Criteria: 1. Participants with dementia or other memory impairment not due to Alzheimer's disease, including, but not limited to, dementia with Lewy bodies, vascular dementia, Parkinson's disease, Huntington disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, normal pressure hydrocephalus, hypoxia, severe sleep apnea or other chronic sleep disturbance, or baseline intellectual disability. 2. Participants with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism. 3. History of significant psychiatric illness such as schizophrenia or bipolar affective disorder, or history or current major depressive disorder in the past year and any other significant psychiatric illness that in the opinion of the investigator could interfere with participation in the study. 4. Participants with delirium or history of delirium within the 30 days prior to the screening visit. 5. Have suicide ideation according to the investigator's clinical judgment as per the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or have made a suicide attempt in the 6 months prior to screening. 6. Clinically significant ECG abnormality as judged by the investigator. 7. Confirmed absolute QTcF \>450 msec for males or \>470 msec for females. 8. Positive results at screening for active viral infections that include human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) RNA PCR test. 9. Participants with total bilirubin, alanine transaminase (ALT) or aspartate transaminase (AST) greater than 1.5×upper limit of normal (ULN), or international normalized ratio (INR) greater than 1.7 at screening. 10. Participants with estimated creatinine clearance (CrCL, Cockcroft-Gault equation) ≤30 mL/min at screening. 11. Participants with a history of treatment, and/or current treatment, with anti-Aβ antibodies 12. Changes in any medications that, in the opinion of the investigator, may potentially impair participants' ability to perform cognitive testing or study procedures during the study period (from Screening to EOT), and their dosing should be stable for at least 1 month before Screening (such as benzodiazepines and sedatives/hypnotics). All concomitant medications must be kept as stable as medically possible during the study. 13. Participants who have taken any investigational products, or used investigational medical devices, within 3 months or five half-lives of the therapy (whichever is longer) with respect to first dosing and throughout the study

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia

As listed by the trial registrant

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

Alzheimer disease

Contacts and locations

Locations

  • AD-CARE; University of Rochester

    Rochester, New York, 14620, United States

  • Accel Research Sites - Brain and Spine Institute

    Port Orange, Florida, 32127, United States

  • ActivMed Research

    Methuen, Massachusetts, 01844, United States

  • Advanced Clinical Institute Inc.

    West Long Branch, New Jersey, 07764, United States

  • Advanced Memory Research Institute of NJ (CenExel AMRI)

    Toms River, New Jersey, 08755, United States

  • Ascension Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007, United States

  • Banner Alzheimer's Institute (BAI)

    Phoenix, Arizona, 85006, United States

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351, United States

  • Be Well Clinical Studies

    Round Rock, Texas, 78681, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • Brain Matters Research

    Delray Beach, Florida, 33445, United States

  • CenExel Rocky Mountain Clinical Research

    Englewood, Colorado, 80113, United States

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Center for Neurosciences-Research

    Tucson, Arizona, 85718, United States

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681, United States

  • Charter Research - Orlando

    Orlando, Florida, 32803, United States

  • Charter Research - The Villages

    The Villages, Florida, 32162, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106, United States

  • Clinical Endpoints

    Scottsdale, Arizona, 85258, United States

  • Conquest Research LLC

    Winter Park, Florida, 32789, United States

  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

    Tokyo, Japan

  • ForCare Clinical Research

    Tampa, Florida, 33647, United States

  • Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • Himeji Central Hospital Clinic

    Hyōgo, Japan

  • Horizon Clinical Research Group

    Cypress, Texas, 77429, United States

  • Ichiekai Itsuki Hospital

    Tokushima, Japan

  • Ikuseikai Shinozuka Hospital

    Gunma, Japan

  • Imon Yukari Neurology Clinic

    Hiroshima, Japan

  • Inage Neurology and Memory Clinic

    Chiba, Japan

  • Jichiidai Station Brain Clinic

    Tochigi, Japan

  • Kagawa Prefectural Central Hospital

    Kagawa, Japan

  • Katayama Medical Clinic

    Okayama, Japan

  • Kingfisher Cooperative; LLC

    Spokane, Washington, 99201, United States

  • Kobe City Medical Center General Hospital

    Hyōgo, Japan

  • Mabashi Clinic

    Chiba, Japan

  • Meiwakai Izaki Clinic

    Nagasaki, Japan

  • Memory Clinic Ochanomizu

    Tokyo, Japan

  • Memory Clinic Toride

    Ibaraki, Japan

  • NHO Hiroshima-Nishi Medical Center

    Hiroshima, Japan

  • NYU Center for Cognitive Neurology

    New York, New York, 10016, United States

  • National Center for Geriatrics and Gerontology

    Aichi, Japan

  • Neural Net Research / Center for Cognitive Health

    Portland, Oregon, 97225, United States

  • Neuro Behavioral Clinical Research, Inc.

    North Canton, Ohio, 44720, United States

  • NeuroScience Research Center

    Canton, Ohio, 44718, United States

  • Neurology Center of North Orange County

    Fullerton, California, 92835, United States

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018, United States

  • Neurology Diagnostics Research

    Dayton, Ohio, 45459, United States

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211, United States

  • Olympus Clinical Research - Katy

    Katy, Texas, 77450, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Profound Research LLC at The Neurology Center of Southern California

    Carlsbad, California, 92011, United States

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140, United States

  • Re:Cognition Health - Fairfax

    Fairfax, Virginia, 22031, United States

  • Re:Cognition Health-Chicago

    Chicago, Illinois, 60611, United States

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies CRU

    Decatur, Georgia, 30030, United States

  • Southern Tohoku Medical Clinic

    Fukushima, Japan

  • Stanford University

    Palo Alto, California, 94304, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652, United States

  • Sunwise Clinical Research

    Walnut Creek, California, 94596, United States

  • Takesato Hospital

    Saitama, Japan

  • Texas Neurology

    Dallas, Texas, 75206, United States

  • The Cognitive and Research Center of New Jersey

    Springfield, New Jersey, 07081, United States

  • The Feinstein Institutes for Medical Research

    Manhasset, New York, 11030, United States

  • The Ohio State University

    Columbus, Ohio, 43221, United States

  • Tokyo Medical University Hospital

    Tokyo, Japan

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    Tokyo, Japan

  • USF Health Byrd Alzheimer's Institute

    Tampa, Florida, 33613, United States

  • Univ of Kentucky Sanders-Brown Center on Aging

    Lexington, Kentucky, 40504, United States

  • University at Buffalo

    Buffalo, New York, 14203, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center

    Fairway, Kansas, 66205, United States

  • Vanderbilt UMC-Cognitive Med

    Nashville, Tennessee, 37212, United States

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128, United States

  • Velocity Clinical Research at Raleigh Neurology

    Raleigh, North Carolina, 27607, United States

  • Velocity Clinical Research, Boise

    Meridian, Idaho, 83642, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.