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

Status: Recruiting
Location: See all (101) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

• 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.

• 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.

• AD numeric clinical stage 4 or stage 5 based on NIA-AA criteria 2024, at screening and baseline visits

• 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.

• Have the ability to comply with procedures for cognitive and other tests in the opinion of the investigator

• If female, postmenopausal for at least 1 year

• 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.

• 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.

⁃ General health status acceptable for participation in the study, and the participant must be able to ingest pills.

⁃ 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arkansas
Baptist Health Center for Clinical Research
TERMINATED
Little Rock
Arizona
Banner Alzheimer's Institute (BAI)
RECRUITING
Phoenix
Clinical Endpoints
RECRUITING
Scottsdale
Banner Sun Health Research Institute
RECRUITING
Sun City
Center for Neurosciences-Research
RECRUITING
Tucson
California
Advanced Research Center; Inc
RECRUITING
Anaheim
Profound Research LLC at The Neurology Center of Southern California
RECRUITING
Carlsbad
Ark Clinical Research
WITHDRAWN
Fountain Valley
Neurology Center of North Orange County
RECRUITING
Fullerton
Stanford University
RECRUITING
Palo Alto
Sunwise Clinical Research
RECRUITING
Walnut Creek
Colorado
CenExel Rocky Mountain Clinical Research
RECRUITING
Englewood
Florida
Brain Matters Research
RECRUITING
Delray Beach
Neuropsychiatric Research Center of Southwest Florida
WITHDRAWN
Fort Myers
Velocity Clinical Research, Hallandale Beach
RECRUITING
Hallandale
Premier Clinical Research Institute; Inc.
RECRUITING
Miami
Quantum Clinical Trials
SUSPENDED
Miami Beach
Suncoast Clinical Research
RECRUITING
New Port Richey
Renstar Medical Research
RECRUITING
Ocala
Charter Research - Orlando
RECRUITING
Orlando
Accel Research Sites - Brain and Spine Institute
RECRUITING
Port Orange
ForCare Clinical Research
RECRUITING
Tampa
USF Health Byrd Alzheimer's Institute
RECRUITING
Tampa
Charter Research - The Villages
RECRUITING
The Villages
Conquest Research LLC
RECRUITING
Winter Park
Georgia
Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies CRU
RECRUITING
Decatur
CenExel iResearch, LLC
RECRUITING
Savannah
Idaho
Velocity Clinical Research, Boise
RECRUITING
Meridian
Illinois
Charter Research - Chicago
RECRUITING
Chicago
Re:Cognition Health-Chicago
RECRUITING
Chicago
Ascension Alexian Brothers Medical Center
RECRUITING
Elk Grove Village
Kansas
University of Kansas Medical Center
RECRUITING
Fairway
Kentucky
Univ of Kentucky Sanders-Brown Center on Aging
RECRUITING
Lexington
Massachusetts
Boston Clinical Trials
RECRUITING
Boston
ActivMed Research
RECRUITING
Methuen
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
North Carolina
New Hope Clinical Research
TERMINATED
Charlotte
Eximia Research-Raleigh
RECRUITING
Raleigh
Velocity Clinical Research at Raleigh Neurology
RECRUITING
Raleigh
New Jersey
The Cognitive and Research Center of New Jersey
RECRUITING
Springfield
Advanced Memory Research Institute of NJ (CenExel AMRI)
RECRUITING
Toms River
Advanced Clinical Institute Inc.
RECRUITING
West Long Branch
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
NOT_YET_RECRUITING
Las Vegas
Vector Clinical Trials
RECRUITING
Las Vegas
New York
Integrative Clinical Trials
RECRUITING
Brooklyn
University at Buffalo
RECRUITING
Buffalo
Velocity Clinical Research; Syracuse
RECRUITING
East Syracuse
The Feinstein Institutes for Medical Research
RECRUITING
Manhasset
NYU Center for Cognitive Neurology
RECRUITING
New York
AD-CARE; University of Rochester
RECRUITING
Rochester
Stony Brook University Hospital
RECRUITING
Stony Brook
Ohio
NeuroScience Research Center
RECRUITING
Canton
University of Cincinnati
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
The Ohio State University
RECRUITING
Columbus
Neurology Diagnostics Research
RECRUITING
Dayton
Neuro Behavioral Clinical Research, Inc.
RECRUITING
North Canton
Oregon
Neural Net Research / Center for Cognitive Health
RECRUITING
Portland
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Penn Medicine
RECRUITING
Philadelphia
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Tennessee
Neurology Clinic, P.C.
RECRUITING
Cordova
Alliance for Multispecialty Research;LLC-Knoxville
RECRUITING
Knoxville
Vanderbilt UMC-Cognitive Med
RECRUITING
Nashville
Texas
FutureSearch Trials of Neurology
COMPLETED
Austin
Horizon Clinical Research Group
RECRUITING
Cypress
FutureSearch Trials of Dallas LLC
RECRUITING
Dallas
Texas Neurology
RECRUITING
Dallas
Re:Cognition Health - Fort Worth
RECRUITING
Fort Worth
Re:Cognition Health - Houston
RECRUITING
Houston
Olympus Clinical Research - Katy
RECRUITING
Katy
Be Well Clinical Studies
RECRUITING
Round Rock
Central Texas Neurology Consultants
RECRUITING
Round Rock
Grayline Research Center
RECRUITING
Wichita Falls
Utah
Velocity Clinical Research, Salt Lake City
WITHDRAWN
Salt Lake City
Wasatch Clinical Research; LLC
RECRUITING
Salt Lake City
Virginia
Re:Cognition Health - Fairfax
RECRUITING
Fairfax
Sentara Neurology Specialists
RECRUITING
Norfolk
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Kingfisher Cooperative; LLC
RECRUITING
Spokane
Other Locations
Japan
National Center for Geriatrics and Gerontology
RECRUITING
Aichi
Inage Neurology and Memory Clinic
RECRUITING
Chiba
Mabashi Clinic
RECRUITING
Chiba
Southern Tohoku Medical Clinic
RECRUITING
Fukushima
Ikuseikai Shinozuka Hospital
RECRUITING
Gunma
Imon Yukari Neurology Clinic
RECRUITING
Hiroshima
NHO Hiroshima-Nishi Medical Center
RECRUITING
Hiroshima
Himeji Central Hospital Clinic
RECRUITING
Hyōgo
Kobe City Medical Center General Hospital
RECRUITING
Hyōgo
Memory Clinic Toride
RECRUITING
Ibaraki
Kagawa Prefectural Central Hospital
RECRUITING
Kagawa
Meiwakai Izaki Clinic
RECRUITING
Nagasaki
Katayama Medical Clinic
RECRUITING
Okayama
Takesato Hospital
RECRUITING
Saitama
Jichiidai Station Brain Clinic
RECRUITING
Tochigi
Ichiekai Itsuki Hospital
RECRUITING
Tokushima
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
RECRUITING
Tokyo
Memory Clinic Ochanomizu
RECRUITING
Tokyo
Tokyo Medical University Hospital
RECRUITING
Tokyo
Tokyo Metropolitan Institute for Geriatrics and Gerontology
RECRUITING
Tokyo
Contact Information
Primary
North America Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+18665877745(Toll-Free)
Backup
International Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+17162141777(Standard)
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2026-08
Participants
Target number of participants: 240
Treatments
Experimental: ONO-2020 Dose 1
Participants will receive ONO-2020 Dose 1 administered orally, once a day (QD) for 26 weeks.
Experimental: ONO-2020 Dose 2
Participants will receive ONO-2020 Dose 2 administered orally, once a day (QD) for 26 weeks.
Placebo_comparator: Placebo
Participants will receive Placebo administered orally, once a day (QD) for 26 weeks.
Related Therapeutic Areas
Sponsors
Leads: Ono Pharmaceutical Co. Ltd

This content was sourced from clinicaltrials.gov

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