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ACTIVE NOT RECRUITING

NCT06881836

PHASE2

A Study of ONO-2020 in Participants With Mild to Moderate Alzheimer's Disease

Sponsor: Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

Summary

This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess safety, tolerability, pharmacokinetics, and efficacy of ONO-2020 in participants with mild to moderate Alzheimer's disease (AD). This study aims to determine whether administering ONO-2020, an epigenetic regulator, may improve cognitive functions like memory and cognition in individuals with Alzheimer's disease dementia.

Official title: A Phase II, 26-week, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of ONO-2020 in Patients With Mild to Moderate Alzheimer's Disease

Key Details

Gender

All

Age Range

55 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-04-24

Completion Date

2026-08

Last Updated

2026-01-28

Healthy Volunteers

Conditions

Alzheimer Disease

Interventions

DRUG

ONO-2020

ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.

DRUG

Placebo

Placebo group: Two ONO-2020 placebo tablets will be orally administered once daily.

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

Locations (96)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner Alzheimer's Institute (BAI)

Phoenix, Arizona, United States

Clinical Endpoints

Scottsdale, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Center for Neurosciences-Research

Tucson, Arizona, United States

Profound Research LLC at The Neurology Center of Southern California

Carlsbad, California, United States

Neurology Center of North Orange County

Fullerton, California, United States

Stanford University

Palo Alto, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, United States

Brain Matters Research

Delray Beach, Florida, United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Premier Clinical Research Institute; Inc.

Miami, Florida, United States

Quantum Clinical Trials

Miami Beach, Florida, United States

Suncoast Clinical Research

New Port Richey, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Charter Research - Orlando

Orlando, Florida, United States

Accel Research Sites - Brain and Spine Institute

Port Orange, Florida, United States

USF Health Byrd Alzheimer's Institute

Tampa, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Charter Research - The Villages

The Villages, Florida, United States

Conquest Research LLC

Winter Park, Florida, United States

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

Decatur, Georgia, United States

CenExel iResearch, LLC

Savannah, Georgia, United States

Velocity Clinical Research, Boise

Meridian, Idaho, United States

Re:Cognition Health-Chicago

Chicago, Illinois, United States

Charter Research - Chicago

Chicago, Illinois, United States

Ascension Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

University of Kansas Medical Center

Fairway, Kansas, United States

Univ of Kentucky Sanders-Brown Center on Aging

Lexington, Kentucky, United States

Boston Clinical Trials

Boston, Massachusetts, United States

ActivMed Research

Methuen, Massachusetts, United States

Quest Research Institute

Farmington Hills, Michigan, United States

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, United States

Advanced Memory Research Institute of NJ (CenExel AMRI)

Toms River, New Jersey, United States

Advanced Clinical Institute Inc.

West Long Branch, New Jersey, United States

Integrative Clinical Trials

Brooklyn, New York, United States

University at Buffalo

Buffalo, New York, United States

Velocity Clinical Research; Syracuse

East Syracuse, New York, United States

The Feinstein Institutes for Medical Research

Manhasset, New York, United States

NYU Center for Cognitive Neurology

New York, New York, United States

AD-CARE; University of Rochester

Rochester, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Eximia Research-Raleigh

Raleigh, North Carolina, United States

Velocity Clinical Research at Raleigh Neurology

Raleigh, North Carolina, United States

NeuroScience Research Center

Canton, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Neurology Diagnostics Research

Dayton, Ohio, United States

Neuro Behavioral Clinical Research, Inc.

North Canton, Ohio, United States

Neural Net Research / Center for Cognitive Health

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn Medicine

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Alliance for Multispecialty Research;LLC-Knoxville

Knoxville, Tennessee, United States

Vanderbilt UMC-Cognitive Med

Nashville, Tennessee, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Horizon Clinical Research Group

Cypress, Texas, United States

Texas Neurology

Dallas, Texas, United States

FutureSearch Trials of Dallas LLC

Dallas, Texas, United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas, United States

Re:Cognition Health - Houston

Houston, Texas, United States

Olympus Clinical Research - Katy

Katy, Texas, United States

Be Well Clinical Studies

Round Rock, Texas, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

Wasatch Clinical Research; LLC

Salt Lake City, Utah, United States

Re:Cognition Health - Fairfax

Fairfax, Virginia, United States

Sentara Neurology Specialists

Norfolk, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Kingfisher Cooperative; LLC

Spokane, Washington, United States

National Center for Geriatrics and Gerontology

Aichi, Japan

Inage Neurology and Memory Clinic

Chiba, Japan

Mabashi Clinic

Chiba, Japan

Southern Tohoku Medical Clinic

Fukushima, Japan

Ikuseikai Shinozuka Hospital

Gunma, Japan

Imon Yukari Neurology Clinic

Hiroshima, Japan

NHO Hiroshima-Nishi Medical Center

Hiroshima, Japan

Himeji Central Hospital Clinic

Hyōgo, Japan

Kobe City Medical Center General Hospital

Hyōgo, Japan

Memory Clinic Toride

Ibaraki, Japan

Kagawa Prefectural Central Hospital

Kagawa, Japan

Meiwakai Izaki Clinic

Nagasaki, Japan

Katayama Medical Clinic

Okayama, Japan

Takesato Hospital

Saitama, Japan

Jichiidai Station Brain Clinic

Tochigi, Japan

Ichiekai Itsuki Hospital

Tokushima, Japan

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tokyo, Japan

Memory Clinic Ochanomizu

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Tokyo Metropolitan Institute for Geriatrics and Gerontology

Tokyo, Japan

Clinical Research Directory

A Study of ONO-2020 in Participants With Mild to Moderate Alzheimer's Disease

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (96)