A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-90
SponsorOno Pharmaceutical Co., Ltd.
About this trial
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ONO-2020
DrugONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
Placebo
DrugTwo ONO-2020 placebo tablets will be orally administered once daily
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: ONO-2020Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in CMAI score from baseline
To assess agitation symptoms
Time frame
up to week 122
Adverse events
To Evaluate the Safety
Time frame
up to week 163
Body weight
To Evaluate the Safety
Time frame
up to week 164
Body temperature
To Evaluate the Safety
Time frame
up to week 16Secondary outcomes
1
Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline
To Evaluate the Efficacy The range of CMAI score is 29-203. Higher score means a worse outcome.
Time frame
up to 12 week2
Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline
To Evaluate the Efficacy The range of CGI-S score is 0-7. Higher score means a worse outcome.
Time frame
up to 12 week3
Clinical Global Impression-Severity （CGI-S） score at each visit
To Evaluate the Efficacy
Time frame
up to 12 week4
Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline
To Evaluate the Efficacy The range of NPI-NH score is 0-170. Higher score means a worse outcome.
Time frame
up to 12 weekSponsors and contacts
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Source ClinicalTrials.gov