A Study of ONO-2020 in Participants With Mild to Moderate Alzheimer's Disease
Purpose
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.
Condition
- Alzheimer Disease
Eligibility
- Eligible Ages
- Between 55 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35233
Birmingham 4049979, Alabama 4829764 35233
Banner Alzheimer's Institute (BAI)
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
Clinical Endpoints
Scottsdale 5313457, Arizona 5551752 85258
Scottsdale 5313457, Arizona 5551752 85258
Banner Sun Health Research Institute
Sun City 5316201, Arizona 5551752 85351
Sun City 5316201, Arizona 5551752 85351
Center for Neurosciences-Research
Tucson 5318313, Arizona 5551752 85718
Tucson 5318313, Arizona 5551752 85718
Advanced Research Center; Inc
Anaheim 5323810, California 5332921 92805
Anaheim 5323810, California 5332921 92805
Profound Research LLC at The Neurology Center of Southern California
Carlsbad 5334223, California 5332921 92011
Carlsbad 5334223, California 5332921 92011
Neurology Center of North Orange County
Fullerton 5351247, California 5332921 92835
Fullerton 5351247, California 5332921 92835
Neurology Center of North Orange County
Fullerton 5351247, California 5332921 92835
Fullerton 5351247, California 5332921 92835
Stanford University
Palo Alto 5380748, California 5332921 94304
Palo Alto 5380748, California 5332921 94304
Sunwise Clinical Research
Walnut Creek 5406990, California 5332921 94596
Walnut Creek 5406990, California 5332921 94596
CenExel Rocky Mountain Clinical Research
Englewood 5421250, Colorado 5417618 80113
Englewood 5421250, Colorado 5417618 80113
Brain Matters Research
Delray Beach 4153132, Florida 4155751 33445
Delray Beach 4153132, Florida 4155751 33445
Velocity Clinical Research, Hallandale Beach
Hallandale 4157898, Florida 4155751 33009
Hallandale 4157898, Florida 4155751 33009
Premier Clinical Research Institute; Inc.
Miami 4164138, Florida 4155751 33122
Miami 4164138, Florida 4155751 33122
Quantum Clinical Trials
Miami Beach 4164143, Florida 4155751 33140
Miami Beach 4164143, Florida 4155751 33140
Suncoast Clinical Research
New Port Richey 4165869, Florida 4155751 34652
New Port Richey 4165869, Florida 4155751 34652
Renstar Medical Research
Ocala 4166673, Florida 4155751 34470
Ocala 4166673, Florida 4155751 34470
Charter Research - Orlando
Orlando 4167147, Florida 4155751 32803
Orlando 4167147, Florida 4155751 32803
Accel Research Sites - Brain and Spine Institute
Port Orange 4169156, Florida 4155751 32127
Port Orange 4169156, Florida 4155751 32127
USF Health Byrd Alzheimer's Institute
Tampa 4174757, Florida 4155751 33613
Tampa 4174757, Florida 4155751 33613
ForCare Clinical Research
Tampa 4174757, Florida 4155751 33647
Tampa 4174757, Florida 4155751 33647
Charter Research - The Villages
The Villages 4175179, Florida 4155751 32162
The Villages 4175179, Florida 4155751 32162
Conquest Research LLC
Winter Park 4178560, Florida 4155751 32789
Winter Park 4178560, Florida 4155751 32789
Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies CRU
Decatur 4191124, Georgia 4197000 30030
Decatur 4191124, Georgia 4197000 30030
CenExel iResearch, LLC
Savannah 4221552, Georgia 4197000 31405
Savannah 4221552, Georgia 4197000 31405
Velocity Clinical Research, Boise
Meridian 5600685, Idaho 5596512 83642
Meridian 5600685, Idaho 5596512 83642
Re:Cognition Health-Chicago
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
Charter Research - Chicago
Chicago 4887398, Illinois 4896861 60618
Chicago 4887398, Illinois 4896861 60618
Ascension Alexian Brothers Medical Center
Elk Grove Village 4890925, Illinois 4896861 60007
Elk Grove Village 4890925, Illinois 4896861 60007
University of Kansas Medical Center
Fairway 4271358, Kansas 4273857 66205
Fairway 4271358, Kansas 4273857 66205
Univ of Kentucky Sanders-Brown Center on Aging
Lexington 4297983, Kentucky 6254925 40504
Lexington 4297983, Kentucky 6254925 40504
Boston Clinical Trials
Boston 4930956, Massachusetts 6254926 02131
Boston 4930956, Massachusetts 6254926 02131
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
ActivMed Research
Methuen 4943828, Massachusetts 6254926 01844
Methuen 4943828, Massachusetts 6254926 01844
Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334
Farmington Hills 4992523, Michigan 5001836 48334
Vector Clinical Trials
Las Vegas 5506956, Nevada 5509151 89128
Las Vegas 5506956, Nevada 5509151 89128
The Cognitive and Research Center of New Jersey
Springfield 5104952, New Jersey 5101760 07081
Springfield 5104952, New Jersey 5101760 07081
Advanced Memory Research Institute of NJ (CenExel AMRI)
Toms River 4504476, New Jersey 5101760 08755
Toms River 4504476, New Jersey 5101760 08755
Advanced Clinical Institute Inc.
West Long Branch 5106275, New Jersey 5101760 07764
West Long Branch 5106275, New Jersey 5101760 07764
Integrative Clinical Trials
Brooklyn 5110302, New York 5128638 11229
Brooklyn 5110302, New York 5128638 11229
University at Buffalo
Buffalo 5110629, New York 5128638 14203
Buffalo 5110629, New York 5128638 14203
Velocity Clinical Research; Syracuse
East Syracuse 5116079, New York 5128638 13057
East Syracuse 5116079, New York 5128638 13057
The Feinstein Institutes for Medical Research
Manhasset 5125766, New York 5128638 11030
Manhasset 5125766, New York 5128638 11030
NYU Center for Cognitive Neurology
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
AD-CARE; University of Rochester
Rochester 5134086, New York 5128638 14620
Rochester 5134086, New York 5128638 14620
Stony Brook University Hospital
Stony Brook 5139865, New York 5128638 11794
Stony Brook 5139865, New York 5128638 11794
Eximia Research-Raleigh
Raleigh 4487042, North Carolina 4482348 27607
Raleigh 4487042, North Carolina 4482348 27607
Velocity Clinical Research at Raleigh Neurology
Raleigh 4487042, North Carolina 4482348 27607
Raleigh 4487042, North Carolina 4482348 27607
NeuroScience Research Center
Canton 5149222, Ohio 5165418 44718
Canton 5149222, Ohio 5165418 44718
University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45219
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
The Ohio State University
Columbus 4509177, Ohio 5165418 43221
Columbus 4509177, Ohio 5165418 43221
Neurology Diagnostics Research
Dayton 4509884, Ohio 5165418 45459
Dayton 4509884, Ohio 5165418 45459
Neuro Behavioral Clinical Research, Inc.
North Canton 5164706, Ohio 5165418 44720
North Canton 5164706, Ohio 5165418 44720
Neural Net Research / Center for Cognitive Health
Portland 5746545, Oregon 5744337 97225
Portland 5746545, Oregon 5744337 97225
Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
Penn Medicine
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
Providence 5224151, Rhode Island 5224323 02903
Neurology Clinic, P.C.
Cordova 4050552, Tennessee 4662168 38018
Cordova 4050552, Tennessee 4662168 38018
Alliance for Multispecialty Research;LLC-Knoxville
Knoxville 4634946, Tennessee 4662168 37920
Knoxville 4634946, Tennessee 4662168 37920
Vanderbilt UMC-Cognitive Med
Nashville 4644585, Tennessee 4662168 37212
Nashville 4644585, Tennessee 4662168 37212
Horizon Clinical Research Group
Cypress 4684724, Texas 4736286 77429
Cypress 4684724, Texas 4736286 77429
Texas Neurology
Dallas 4684888, Texas 4736286 75206
Dallas 4684888, Texas 4736286 75206
FutureSearch Trials of Dallas LLC
Dallas 4684888, Texas 4736286 75251
Dallas 4684888, Texas 4736286 75251
Re:Cognition Health - Fort Worth
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
Re:Cognition Health - Houston
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Olympus Clinical Research - Katy
Katy 4702732, Texas 4736286 77450
Katy 4702732, Texas 4736286 77450
Be Well Clinical Studies
Round Rock 4724129, Texas 4736286 78681
Round Rock 4724129, Texas 4736286 78681
Central Texas Neurology Consultants
Round Rock 4724129, Texas 4736286 78681
Round Rock 4724129, Texas 4736286 78681
Grayline Research Center
Wichita Falls 4741752, Texas 4736286 76309
Wichita Falls 4741752, Texas 4736286 76309
Wasatch Clinical Research; LLC
Salt Lake City 5780993, Utah 5549030 84107
Salt Lake City 5780993, Utah 5549030 84107
Re:Cognition Health - Fairfax
Fairfax 4758023, Virginia 6254928 22031
Fairfax 4758023, Virginia 6254928 22031
Sentara Neurology Specialists
Norfolk 4776222, Virginia 6254928 23510
Norfolk 4776222, Virginia 6254928 23510
Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007
Bellevue 5786882, Washington 5815135 98007
Kingfisher Cooperative; LLC
Spokane 5811696, Washington 5815135 99201
Spokane 5811696, Washington 5815135 99201
More Details
- NCT ID
- NCT06881836
- Status
- Recruiting
- Sponsor
- Ono Pharmaceutical Co. Ltd
Study Contact
North America Clinical Trial Support Desk+18665877745(Toll-Free)
clinical_trial@ono-pharma.com
Detailed Description
In the study, participants will undergo a screening period of up to 6 weeks (42 days). Eligible participants will be assigned to receive one of 2 dose levels of ONO-2020 or placebo control arm. ONO-2020 or placebo will be administered orally QD for 26 weeks. All participants who received study intervention will be followed up for 4 weeks after treatment discontinuation. The target sample size is 240 participants , out of which up to 45 participants will undergo additional special CSF biomarker evaluation. After enrollment, participants will be randomized in a 1:1:1 ratio to one of 3 treatment arms.