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 (38) 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
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
Fukui Hospital
RECRUITING
Fukui
Matsubara Hospital
RECRUITING
Fukui
Aburayama Hospital
RECRUITING
Fukuoka
Kuramitsu Hospital
RECRUITING
Fukuoka
Kishikai Kishi Hospital
RECRUITING
Gunma
Hayakawa Clinic
RECRUITING
Hiroshima
Koseikai Cocoro Hospital Kusatsu
RECRUITING
Hiroshima
Nakamura Hospital
RECRUITING
Hiroshima
Keiseikai Hospital
RECRUITING
Hokkaido
NHO Obihiro National Hospital
RECRUITING
Hokkaido
Airanomori Hospital
NOT_YET_RECRUITING
Kagoshima
Ishiki Hospital
RECRUITING
Kagoshima
Sansyu Hospital
NOT_YET_RECRUITING
Kagoshima
Taniyama Hospital
NOT_YET_RECRUITING
Kagoshima
Fujisawahospital
RECRUITING
Kanagawa
Hatano Kousei Hospital
RECRUITING
Kanagawa
Showa Medical University Northern Yokohama Hospital
RECRUITING
Kanagawa
Hosogi Hospital
RECRUITING
Kochi
Ichiyo Mental Hospital
RECRUITING
Kochi
Maizuru Medical Center
RECRUITING
Kyoto
Nishiyama Hospital
NOT_YET_RECRUITING
Kyoto
Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
RECRUITING
Miyagi
JA-Nagano North Alps Medical Center Azumi Hospital
RECRUITING
Nagano
Jizenkai Ando Hospital
RECRUITING
Nagano
Nara Medical University Hospital
NOT_YET_RECRUITING
Nara
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
Saitama Konan Hospital
RECRUITING
Saitama
Asuka Hospital
RECRUITING
Tokyo
Nishigahara Hospital
RECRUITING
Tokyo
Sanyokai Sanyo Hospital
RECRUITING
Yamagata
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