Agitation Associated With Alzheimer's Disease Dementia
Conditions
Brief summary
To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.
Interventions
DRUGONO-2020
ONO-2020 group: Two ONO-2020 tablets will be orally administered once daily.
DRUGPlacebo
Two ONO-2020 placebo tablets will be orally administered once daily
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CMAI score from baseline | up to week 12 | To assess agitation symptoms |
| Adverse events | up to week 16 | To Evaluate the Safety |
| Body weight | up to week 16 | To Evaluate the Safety |
| Body temperature | up to week 16 | To Evaluate the Safety |
| Blood pressure | up to week 16 | To Evaluate the Safety |
| Pulse rate | up to week 16 | To Evaluate the Safety |
| Respiratory rate | up to week 16 | To Evaluate the Safety |
| ECG RR interval | up to week 12 | To Evaluate the Safety |
| ECG PR interval | up to week 12 | To Evaluate the Safety |
| ECG QRS complex | up to week 12 | To Evaluate the Safety |
| ECG QT interval | up to week 12 | To Evaluate the Safety |
| ECG QTcF | up to week 12 | To Evaluate the Safety |
| Number of participants with abnormal laboratory tests (hematology) | up to week 12 | Hematology (PT, RBC count, RBC indices, WBC count, Differential, Hemoglobin, Hematocrit) |
| Number of participants with abnormal laboratory tests (Clinical chemistry) | up to week 12 | Clinical chemistry (Blood urea nitrogen (BUN), Potassium, Creatinine, Sodium, Glucose (fasting or nonfasting), Calcium, Chloride, Total protein, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase, Total and direct bilirubin, Lactate dehydrogenase (LDH), Phospholipid, γ-Glutamyl transferase (GGT) |
| Number of participants with abnormal Blood coagulation profile (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR)) | up to week 12 | Blood coagulation (Activated partial thromboplastin time (APTT), Prothrombin time (PT), International normalized ratio (INR)) |
| Number of participants with abnormal Urinalysis | up to week 12 | Urinalysis (pH, Glucose, Protein, Blood, Ketones) |
| COLUMBIA-SUICIDE SEVERITY RATING SCALE（C-SSRS） | up to week 16 | To Evaluate the Safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohen-Mansfield Agitation Inventory (CMAI) score at each visit and change from baseline | up to 12 week | To Evaluate the Efficacy The range of CMAI score is 29-203. Higher score means a worse outcome. |
| Clinical Global Impression-Severity （CGI-S） score at each visit and change from baseline | up to 12 week | To Evaluate the Efficacy The range of CGI-S score is 0-7. Higher score means a worse outcome. |
| Clinical Global Impression-Severity （CGI-S） score at each visit | up to 12 week | To Evaluate the Efficacy |
| Neuropsychiatric Inventory in Nursing Home Version（NPI-NH） score at each visit and change from baseline | up to 12 week | To Evaluate the Efficacy The range of NPI-NH score is 0-170. Higher score means a worse outcome. |
| Mini Mental State Exam(MMSE) score at baseline and Week 12, and change from baseline | up to 12 week | To Evaluate the Efficacy The range of MMSE score is 0-30. Higher score means a better outcome. |
| Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)score at baseline and Week 12, and change from baseline | up to 12 week | To Evaluate the Efficacy The range of ADCS-ADL score is 0-78. Higher score means a better outcome. |
| Duration of the investigational medicinal product administration | up to 12 week | To Evaluate the Efficacy |
| Pharmacokinetic assessments | up to 12 week | Plasma ONO-2020 concentrations |
Countries
Japan
Contacts
CONTACTNorth America Clinical Trial Support Desk
CONTACTInternational Clinical Trial Support Desk
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed