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
Profound Research LLC at The Neurology Center of Southern California
Carlsbad, California 92011
Carlsbad, California 92011
Ark Clinical Research
Fountain Valley, California 92708
Fountain Valley, California 92708
Sunwise Clinical Research
Walnut Creek, California 94596
Walnut Creek, California 94596
Brain Matters Research
Delray Beach, Florida 33445
Delray Beach, Florida 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida 33912
Fort Myers, Florida 33912
Velocity Clinical Research, Hallandale Beach
Hallandale Beach, Florida 33009
Hallandale Beach, Florida 33009
Quantum Clinical Trials
Miami Beach, Florida 33140
Miami Beach, Florida 33140
Suncoast Clinical Research
New Port Richey, Florida 34652
New Port Richey, Florida 34652
Renstar Medical Research
Ocala, Florida 34470
Ocala, Florida 34470
Accel Research Sites - Brain and Spine Institute
Port Orange, Florida 32127
Port Orange, Florida 32127
Conquest Research LLC
Winter Park, Florida 32789
Winter Park, Florida 32789
Sandhill Research, LLC d/b/a Accel Research Sites - NeuroStudies CRU
Decatur, Georgia 30030
Decatur, Georgia 30030
CenExel iResearch, LLC
Savannah, Georgia 31405
Savannah, Georgia 31405
Velocity Clinical Research, Boise
Meridian, Idaho 83642
Meridian, Idaho 83642
Boston Clinical Trials
Boston, Massachusetts 02131
Boston, Massachusetts 02131
ActivMed Research
Methuen, Massachusetts 01844
Methuen, Massachusetts 01844
Quest Research Institute
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Vector Clinical Trials
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081
Springfield, New Jersey 07081
Advanced Memory Research Institute of NJ (CenExel AMRI)
Toms River, New Jersey 08755
Toms River, New Jersey 08755
Advanced Clinical Institute Inc.
West Long Branch, New Jersey 07764
West Long Branch, New Jersey 07764
Integrative Clinical Trials
Brooklyn, New York 11229
Brooklyn, New York 11229
Eximia Research-Raleigh
Raleigh, North Carolina 27607
Raleigh, North Carolina 27607
Velocity Clinical Research at Raleigh Neurology
Raleigh, North Carolina 27607
Raleigh, North Carolina 27607
NeuroScience Research Center
Canton, Ohio 44718
Canton, Ohio 44718
Neuro Behavioral Clinical Research, Inc.
North Canton, Ohio 44720
North Canton, Ohio 44720
Neural Net Research / Center for Cognitive Health
Portland, Oregon 97225
Portland, Oregon 97225
Be Well Clinical Studies
Round Rock, Texas 78681
Round Rock, Texas 78681
Grayline Research Center
Wichita Falls, Texas 76309
Wichita Falls, Texas 76309
Velocity Clinical Research, Salt Lake City
Salt Lake City, Utah 84088
Salt Lake City, Utah 84088
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.