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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Incidence, severity, and type of treatment emergent adverse events (TEAEs)
The number and percentage of subjects reporting each TEAE will be summarized by both system organ class (SOC) and preferred term (PT).
Time frame: From baseline up to 26 weeks
Clinically abnormal findings in Columbia Suicide Severity Rating Scale (C-SSRS)
The number and percentage of subjects with clinically abnormal finding will be tabulated at each time point.
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 12 (ADAS-cog 12) score
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in ADAS-cog 12 score in mild AD participants
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in ADAS-cog 12 score in moderate AD participants
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in ADAS-cog 11 and 13 scores
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) score
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in Quick Dementia Rating System (QDRS)
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in Mini-Mental State Examination (MMSE) score
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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
Profound Research LLC at The Neurology Center of Southern California
Carlsbad, 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
...and 86 more locations
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in Quality of Life-Alzheimer's Disease (QoL-AD) Scale
Time frame: From baseline up to 26 weeks
Change from baseline through week 26 in Zarit Burden Interview Scale (ZBI)
Time frame: From baseline up to 26 weeks
Change in plasma concentration of ONO-2020 by dose level and time point
The plasma concentrations of ONO-2020 will be listed, and descriptive summary statistics of them will be calculated by dose level and time point.
Time frame: Day 1, Week 2, Week 10, and Week 26