Clinical trial NCT06803823: A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Agitation Associated With Alzheimer's Disease Dementia
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diagnosis of dementia not due to AD or any other disorder with memory impairment, such as mixed dementia, vascular dementia, Lewy body dementia, dementia associated with Parkinson's disease, frontotemporal dementia, drug-induced dementia, dementia associated with human immunodeficiency virus (HIV) infection, traumatic brain injury, normal pressure hydrocephalus, or other non-AD dementia
* Any MRI or CT scan of the brain performed after the onset of dementia with findings consistent with clinically relevant CNS disease other than AD, such as vascular changes (eg, cortical cerebral infarction, multiple cerebral infarctions), space-occupying lesions (eg, tumors), or any other major structural brain disease
* Delirium within 30 days before the start of the screening period or a history of delirium
* At risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) (answers "yes" to Question 4 or 5 of the suicidal ideation section of the C-SSRS) or any suicide attempt within 6 months before the start of the screening period, or at serious risk of suicide in the opinion of the investigator or subinvestigator
* Prior or current treatment with anti-amyloid beta antibodies

Primary outcomes:
measure: Change in CMAI score from baseline
timeFrame: up to week 12
measure: Adverse events
timeFrame: up to week 16
measure: Body weight
timeFrame: up to week 16
measure: Body temperature
timeFrame: up to week 16
measure: Blood pressure
timeFrame: up to week 16
measure: Pulse rate
timeFrame: up to week 16
measure: Respiratory rate
timeFrame: up to week 16
measure: ECG RR interval
timeFrame: up to week 12
measure: ECG PR interval
timeFrame: up to week 12
measure: ECG QRS complex
timeFrame: up to week 12
measure: ECG QT interval
timeFrame: up to week 12
measure: ECG QTcF
timeFrame: up to week 12
measure: Number of participants with abnormal laboratory tests (hematology)
timeFrame: up to week 12
measure: Number of participants with abnormal laboratory tests (Clinical chemistry)
timeFrame: up to week 12
measure: Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR))
timeFrame: up to week 12
measure: Number of participants with abnormal Urinalysis
timeFrame: up to week 12
measure: COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS）
timeFrame: up to week 16
Secondary outcomes:
measure: Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline
timeFrame: up to 12 week
measure: Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline
timeFrame: up to 12 week
measure: Clinical Global Impression-Severity （CGI-S） score at each visit
timeFrame: up to 12 week
measure: Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline
timeFrame: up to 12 week
measure: Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline
timeFrame: up to 12 week
measure: Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)score at baseline and Week 12, and change from baseline
timeFrame: up to 12 week
measure: Duration of the investigational medicinal product administration
timeFrame: up to 12 week
measure: Pharmacokinetic assessments
timeFrame: up to 12 week
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Hotei Hospital
city: Akita
country: Japan
facility: Akita Prefectural Center For Rehabilitation and Psychiatric Medicine
city: Akita
country: Japan
facility: Medical Corporation Keishinkai Kyowa Hospital
city: Aomori
country: Japan
facility: Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital
city: Aomori
country: Japan
facility: Seinan Hospital
city: Fukui
country: Japan
facility: Matsubara Hospital
city: Fukuoka
country: Japan
facility: Aburayama Hospital
city: Fukuoka
country: Japan
facility: Kuramitsu Hospital
city: Gunma
country: Japan
facility: Kishikai Kishi Hospital
city: Hiroshima
country: Japan
facility: Hayakawa Clinic
city: Hiroshima
country: Japan
facility: Koseikai Cocoro Hospital Kusatsu
city: Hiroshima
country: Japan
facility: Nakamura Hospital
city: Kagoshima
country: Japan
facility: Ishiki Hospital
city: Kanagawa
country: Japan
facility: Fujisawahospital
city: Kanagawa
country: Japan
facility: Hatano Kousei Hospital
city: Kanagawa
country: Japan
facility: Showa Medical University Northern Yokohama Hospital
city: Kyoto
country: Japan
facility: Maizuru Medical Center
city: Miyagi
country: Japan
facility: Iryohojin Shadan Shoshinkai Morinohosupitaru・Aoba
city: Nagano
country: Japan
facility: Jizenkai Ando Hospital
city: Osaka
country: Japan
facility: Nagaokai Neyagawa Sanatorium
city: Osaka
country: Japan
facility: Osaka Institute of Clinical Psychiatry Shin-Abuyama Hospital
city: Saga
country: Japan
facility: Hizen Psychiatric Center
city: Saga
country: Japan
facility: Rainbow & Sea Hospital
city: Tokyo
country: Japan
facility: Asuka Hospital
city: Tokyo
country: Japan
facility: Nishigahara Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: