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 (50) 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
California
Profound Research LLC at The Neurology Center of Southern California
RECRUITING
Carlsbad
Ark Clinical Research
RECRUITING
Fountain Valley
Sunwise Clinical Research
RECRUITING
Walnut Creek
Florida
Brain Matters Research
RECRUITING
Delray Beach
Neuropsychiatric Research Center of Southwest Florida
RECRUITING
Fort Myers
Velocity Clinical Research, Hallandale Beach
RECRUITING
Hallandale
Quantum Clinical Trials
RECRUITING
Miami Beach
Suncoast Clinical Research
RECRUITING
New Port Richey
Renstar Medical Research
RECRUITING
Ocala
Accel Research Sites - Brain and Spine Institute
RECRUITING
Port Orange
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
Massachusetts
Boston Clinical Trials
RECRUITING
Boston
ActivMed Research
RECRUITING
Methuen
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
North Carolina
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
Vector Clinical Trials
RECRUITING
Las Vegas
New York
Integrative Clinical Trials
RECRUITING
Brooklyn
Ohio
NeuroScience Research Center
RECRUITING
Canton
Neuro Behavioral Clinical Research, Inc.
RECRUITING
North Canton
Oregon
Neural Net Research / Center for Cognitive Health
RECRUITING
Portland
Tennessee
Neurology Clinic, P.C.
RECRUITING
Cordova
Texas
Be Well Clinical Studies
RECRUITING
Round Rock
Grayline Research Center
RECRUITING
Wichita Falls
Utah
Velocity Clinical Research, Salt Lake City
RECRUITING
Salt Lake City
Other Locations
Japan
National Center for Geriatrics and Gerontology
NOT_YET_RECRUITING
Aichi
Inage Neurology and Memory Clinic
RECRUITING
Chiba
Mabashi Clinic
RECRUITING
Chiba
Southern Tohoku Medical Clinic
NOT_YET_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
NOT_YET_RECRUITING
Hyōgo
Memory Clinic Toride
RECRUITING
Ibaraki
Kagawa Prefectural Central Hospital
NOT_YET_RECRUITING
Kagawa
Meiwakai Izaki Clinic
RECRUITING
Nagasaki
Katayama Medical Clinic
RECRUITING
Okayama
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
NOT_YET_RECRUITING
Tokyo
Tokyo Metropolitan Institute for Geriatrics and Gerontology
NOT_YET_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