A Study of ONO-2020 in Participants With Mild to Moderate Alzheimer's Disease
NCT ID: NCT06881836
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2025-04-24
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ONO-2020 Dose 1
Participants will receive ONO-2020 Dose 1 administered orally, once a day (QD) for 26 weeks.
ONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
ONO-2020 Dose 2
Participants will receive ONO-2020 Dose 2 administered orally, once a day (QD) for 26 weeks.
ONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
Placebo
Participants will receive Placebo administered orally, once a day (QD) for 26 weeks.
Placebo
Placebo group: Two ONO-2020 placebo tablets will be orally administered once daily.
Interventions
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ONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
Placebo
Placebo group: Two ONO-2020 placebo tablets will be orally administered once daily.
Eligibility Criteria
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Inclusion Criteria
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
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
55 Years
85 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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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
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Advanced Research Center; Inc
Anaheim, California, United States
Profound Research LLC at The Neurology Center of Southern California
Carlsbad, California, United States
Ark Clinical Research
Fountain Valley, California, United States
Neurology Center of North Orange County
Fullerton, 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
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, 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
Velocity Clinical Research, Salt Lake City
Salt Lake City, Utah, 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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jRCT2031240712
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-2020-02
Identifier Type: -
Identifier Source: org_study_id
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