ACTIVE_NOT_RECRUITING

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

Conditions

Alzheimer Disease mild to moderate Alzheimer Disease Dementia ONO-2020

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-04-24

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06881836

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Project Leader

STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Banner Alzheimer's Institute (BAI)

Phoenix, Arizona, 85006

United States

Clinical Endpoints

Scottsdale, Arizona, 85258

United States

Banner Sun Health Research Institute

Sun City, Arizona, 85351

United States

Center for Neurosciences-Research

Tucson, Arizona, 85718

United States

Profound Research LLC at The Neurology Center of Southern California

Carlsbad, California, 92011

United States

Neurology Center of North Orange County

Fullerton, California, 92835

United States

Stanford University

Palo Alto, California, 94304

United States

Sunwise Clinical Research

Walnut Creek, California, 94596

United States

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, 80113

United States

Brain Matters Research

Delray Beach, Florida, 33445

United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009

United States

Premier Clinical Research Institute; Inc.

Miami, Florida, 33122

United States

Quantum Clinical Trials

Miami Beach, Florida, 33140

United States

Suncoast Clinical Research

New Port Richey, Florida, 34652

United States

Renstar Medical Research

Ocala, Florida, 34470

United States

Charter Research - Orlando

Orlando, Florida, 32803

United States

Accel Research Sites - Brain and Spine Institute

Port Orange, Florida, 32127

United States

USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613

United States

ForCare Clinical Research

Tampa, Florida, 33647

United States

Charter Research - The Villages

The Villages, Florida, 32162

United States

Conquest Research LLC

Winter Park, Florida, 32789

United States

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

Decatur, Georgia, 30030

United States

CenExel iResearch, LLC

Savannah, Georgia, 31405

United States

Velocity Clinical Research, Boise

Meridian, Idaho, 83642

United States

Re:Cognition Health-Chicago

Chicago, Illinois, 60611

United States

Charter Research - Chicago

Chicago, Illinois, 60618

United States

Ascension Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007

United States

University of Kansas Medical Center

Fairway, Kansas, 66205

United States

Univ of Kentucky Sanders-Brown Center on Aging

Lexington, Kentucky, 40504

United States

Boston Clinical Trials

Boston, Massachusetts, 02131

United States

ActivMed Research

Methuen, Massachusetts, 01844

United States

Quest Research Institute

Farmington Hills, Michigan, 48334

United States

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106

United States

Vector Clinical Trials

Las Vegas, Nevada, 89128

United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, 07081

United States

Advanced Memory Research Institute of NJ (CenExel AMRI)

Toms River, New Jersey, 08755

United States

Advanced Clinical Institute Inc.

West Long Branch, New Jersey, 07764

United States

Integrative Clinical Trials

Brooklyn, New York, 11229

United States

University at Buffalo

Buffalo, New York, 14203

United States

Velocity Clinical Research; Syracuse

East Syracuse, New York, 13057

United States

The Feinstein Institutes for Medical Research

Manhasset, New York, 11030

United States

NYU Center for Cognitive Neurology

New York, New York, 10016

United States

AD-CARE; University of Rochester

Rochester, New York, 14620

United States

Stony Brook University Hospital

Stony Brook, New York, 11794

United States

New Hope Clinical Research

Charlotte, North Carolina, 28211

United States

Eximia Research-Raleigh

Raleigh, North Carolina, 27607

United States

Velocity Clinical Research at Raleigh Neurology

Raleigh, North Carolina, 27607

United States

NeuroScience Research Center

Canton, Ohio, 44718

United States

University of Cincinnati

Cincinnati, Ohio, 45219

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

The Ohio State University

Columbus, Ohio, 43221

United States

Neurology Diagnostics Research

Dayton, Ohio, 45459

United States

Neuro Behavioral Clinical Research, Inc.

North Canton, Ohio, 44720

United States

Neural Net Research / Center for Cognitive Health

Portland, Oregon, 97225

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Penn Medicine

Philadelphia, Pennsylvania, 19104

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Neurology Clinic, P.C.

Cordova, Tennessee, 38018

United States

Alliance for Multispecialty Research;LLC-Knoxville

Knoxville, Tennessee, 37920

United States

Vanderbilt UMC-Cognitive Med

Nashville, Tennessee, 37212

United States

FutureSearch Trials of Neurology

Austin, Texas, 78731

United States

Horizon Clinical Research Group

Cypress, Texas, 77429

United States

Texas Neurology

Dallas, Texas, 75206

United States

FutureSearch Trials of Dallas LLC

Dallas, Texas, 75251

United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas, 76104

United States

Re:Cognition Health - Houston

Houston, Texas, 77030

United States

Olympus Clinical Research - Katy

Katy, Texas, 77450

United States

Be Well Clinical Studies

Round Rock, Texas, 78681

United States

Central Texas Neurology Consultants

Round Rock, Texas, 78681

United States

Grayline Research Center

Wichita Falls, Texas, 76309

United States

Wasatch Clinical Research; LLC

Salt Lake City, Utah, 84107

United States

Re:Cognition Health - Fairfax

Fairfax, Virginia, 22031

United States

Sentara Neurology Specialists

Norfolk, Virginia, 23510

United States

Northwest Clinical Research Center

Bellevue, Washington, 98007

United States

Kingfisher Cooperative; LLC

Spokane, Washington, 99201

United States

Collaborators and Investigators

Sponsor: Ono Pharmaceutical Co. Ltd

Project Leader, STUDY_DIRECTOR, Ono Pharmaceutical Co. Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-24

Study Completion Date2026-08

Study Record Updates

Study Start Date2025-04-24

Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

Alzheimer Disease
mild to moderate Alzheimer Disease
Dementia
ONO-2020

Additional Relevant MeSH Terms

Alzheimer Disease