Trials / Active Not Recruiting

Active Not RecruitingNCT06881836

A Study of ONO-2020 in Participants With Mild to Moderate Alzheimer's Disease

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: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 240 (estimated)

Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
Sex: All
Age: 55 Years – 85 Years
Healthy volunteers: Not accepted

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.

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.

Conditions

Alzheimer Disease

Interventions

Type	Name	Description
DRUG	ONO-2020	ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
DRUG	Placebo	Placebo group: Two ONO-2020 placebo tablets will be orally administered once daily.

Timeline

Start date: 2025-04-24
Primary completion: 2026-07-01
Completion: 2026-08-01
First posted: 2025-03-18
Last updated: 2026-01-28

Locations

96 sites across 2 countries: United States, Japan

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06881836. Inclusion in this directory is not an endorsement.