Recruiting NCT06803823
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ONO-2020, Placebo.
- Who it may be relevant to
- Registry conditions: Agitation Associated With Alzheimer's Disease Dementia. Basic parameters: 55 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Interventions
- Drug ONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily. - Drug Placebo
Two ONO-2020 placebo tablets will be orally administered once daily
Primary outcome measures
- Change in CMAI score from baseline [Time frame: up to week 12]
- Adverse events [Time frame: up to week 16]
- Body weight [Time frame: up to week 16]
- Body temperature [Time frame: up to week 16]
- Blood pressure [Time frame: up to week 16]
- Pulse rate [Time frame: up to week 16]
- Respiratory rate [Time frame: up to week 16]
- ECG RR interval [Time frame: up to week 12]
- ECG PR interval [Time frame: up to week 12]
- ECG QRS complex [Time frame: up to week 12]
Secondary outcome measures (8)
- Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline [Time frame: up to 12 week]
- Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline [Time frame: up to 12 week]
- Clinical Global Impression-Severity （CGI-S） score at each visit [Time frame: up to 12 week]
- Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline [Time frame: up to 12 week]
- Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline [Time frame: up to 12 week]
- Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)score at baseline and Week 12, and change from baseline [Time frame: up to 12 week]
- Duration of the investigational medicinal product administration [Time frame: up to 12 week]
- Pharmacokinetic assessments [Time frame: up to 12 week]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Japan · 38 centers
- Hotei Hospital — Aichi
- Akita Prefectural Center For Rehabilitation and Psychiatric Medicine — Akita
- Medical Corporation Keishinkai Kyowa Hospital — Akita
- Aiseikai General Incorporated Foundation, Hirosaki Aiseikai Hospital — Aomori
- Seinan Hospital — Aomori
- Fukui Hospital — Fukui
- Matsubara Hospital — Fukui
- Aburayama Hospital — Fukuoka
- … and 30 more centers
Identifiers
NCT: NCT06803823 · ONO-2020-03 · jRCT2041230153