A Phase 2a, Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: f
View:
• Diagnosis of probable AD according to the diagnostic criteria for AD dementia (NIA-AA 2011)
• Mini-Mental State Examination (MMSE) score ≥ 5 to ≤ 22 at the start of the treatment period
• Symptoms of agitation defined by the IPA from at least 14 days before the start of the screening period
• Neuropsychiatric Inventory-Nursing Home version (NPI-NH) Agitation/Aggression domain (NPI-NH-A/A) score ≥ 4 at the start of the treatment period.
• Patients who can participate in the study under hospitalization from 21 days before the start of the treatment period to throughout the treatment period
Locations
Other Locations
Japan
Hotei Hospital
NOT_YET_RECRUITING
Aichi
Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
RECRUITING
Akita
Medical Corporation Keishinkai Kyowa Hospital
RECRUITING
Akita
Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
RECRUITING
Aomori
Seinan Hospital
RECRUITING
Aomori
Matsubara Hospital
NOT_YET_RECRUITING
Fukui
Aburayama Hospital
RECRUITING
Fukuoka
Kuramitsu Hospital
RECRUITING
Fukuoka
Kishikai Kishi Hospital
NOT_YET_RECRUITING
Gunma
Hayakawa Clinic
NOT_YET_RECRUITING
Hiroshima
Koseikai Cocoro Hospital Kusatsu
NOT_YET_RECRUITING
Hiroshima
Nakamura Hospital
NOT_YET_RECRUITING
Hiroshima
Ishiki Hospital
NOT_YET_RECRUITING
Kagoshima
Fujisawahospital
NOT_YET_RECRUITING
Kanagawa
Hatano Kousei Hospital
RECRUITING
Kanagawa
Showa Medical University Northern Yokohama Hospital
RECRUITING
Kanagawa
Maizuru Medical Center
RECRUITING
Kyoto
Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
RECRUITING
Miyagi
Jizenkai Ando Hospital
NOT_YET_RECRUITING
Nagano
Nagaokai Neyagawa Sanatorium
RECRUITING
Osaka
Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
RECRUITING
Osaka
Hizen Psychiatric Center
RECRUITING
Saga
Rainbow & Sea Hospital
RECRUITING
Saga
Asuka Hospital
RECRUITING
Tokyo
Nishigahara Hospital
RECRUITING
Tokyo
Contact Information
Primary
North America Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+18665877745(Toll-Free)
Backup
International Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+17162141777(Standard)
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 90
Treatments
Experimental: ONO-2020
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Ono Pharmaceutical Co. Ltd