A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
NCT06803823 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-05-12
Summary
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Conditions
- Agitation Associated With Alzheimer's Disease Dementia
Interventions
- DRUG
-
ONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
- DRUG
-
Two ONO-2020 placebo tablets will be orally administered once daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Project Leader · Ono Pharmaceutical Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
Countries
- Japan
Study Locations
More Related Trials
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)
NCT05262023 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Nabilone for Agitation Blinded Intervention Trial
NCT04516057 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of the Safety, Tolerability, and Pharmacodynamics of MK-8931 in Participants With Alzheimer's Disease (MK-8931-010 AM1 [P07820 AM1])
NCT01496170 ·Status: COMPLETED ·Phase: PHASE1
-
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT03393520 ·Status: COMPLETED ·Phase: PHASE3
-
A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation
NCT03636204 ·Status: COMPLETED ·Phase: PHASE1
-
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
NCT04797715 ·Status: COMPLETED ·Phase: PHASE3
-
Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
NCT00095719 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
NCT00607308 ·Status: COMPLETED ·Phase: PHASE1
-
Nabilone for Agitation in Frontotemporal Dementia
NCT05742698 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)
NCT05602727 ·Status: TERMINATED ·Phase: PHASE2
-
Memantine for Agitation in Dementia
NCT00371059 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
NCT06651567 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT02442765 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type
NCT02442778 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease
NCT06546995 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
NCT06808984 ·Status: RECRUITING ·Phase: PHASE2
-
A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease
NCT05804383 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT04464564 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of BNC210 in Elderly Patients With Agitation
NCT03548194 ·Status: COMPLETED ·Phase: PHASE2
-
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
NCT02446132 ·Status: TERMINATED ·Phase: PHASE3
-
Effects of ONO-2506PO in Patients With Alzheimer's Disease
NCT00083421 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
NCT04592874 ·Status: COMPLETED ·Phase: PHASE2
-
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
NCT03620981 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Multiple Ascending Dose Study of BPN14770 in Healthy Young and Elderly Male or Female Subjects
NCT02840279 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease
NCT01569516 ·Status: UNKNOWN ·Phase: PHASE2