Alzheimer’s Disease – ONO-2020-02
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.
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.
- 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
- Other criteria may apply
Complete the form and our team will reach out soon to help determine your eligibility.