Alzheimer's Disease
Conditions
Brief summary
This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD).
Interventions
DRUGAlfoatirin® Tab. + Aripezil® Tab.
Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks
DRUGAripezil® Tab.
Donepezil 10 mg Oral Tablet qd for 24 weeks
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 50 - 90 years of age * Clinical diagnosis of dementia of the Alzheimer type determined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria * A diagnosis of probable Alzheimer's Disease, or mild to moderate AD determined by NIA-AA (National Institute on Aging and the Alzheimer's Association) criteria * K-MMSE score of 12 - 26 * Global Clinical Dementia Rating (CDR) score of 0.5 - 2 * Patient taking 10 mg of donepezil per day for a minimum of 12 weeks with a stable dose, not taking other brain pills including choline alfoscerate for at least 2 weeks from screening. Drugs that are likely to affect cognition are permissible if the dose is regular and stable for at least 2 weeks before screening and if the treatment continues for the duration of the trial.
Exclusion criteria
* Subject suspected of dementia due to organic causes other than Alzheimer's type dementia * Other degenerative brain diseases or major mental illnesses such as major depression, bipolar disorder, alcohol/substance abuse or dependence, delirium * Hypersensitive to choline alfoscerate, donepezil hydrochloride, or piperidine derivatives or the components of this drug * Subject who has contraindications as listed in the SPC of choline alfoscerate or donepezil hydrochloride * Other than the above who is deemed to be ineligible to participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADAS-cog | At 24 weeks | To evaluate cognitive function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| K-MMSE (Korean version of Mini-Mental State Examination) | At 12 and 24 weeks | To evaluate cognitive function |
| FAB (Frontal Assessment Battery) | At 12 and 24 weeks | To evaluate frontal lobe dysfunction |
| ADAS-cog | At 12 weeks | To evaluate cognitive function |
| CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory) | At 12 and 24 weeks | To evaluate neuropsychiatric symptom in dementia |
| Changes in brain metabolism by F-18 FDG brain PET | At 24 weeks | — |
| S-IADL (Seoul-Instrumental Activities of Daily Living) | At 12 and 24 weeks | To evaluate daily activities of living |
Countries
South Korea
Outcome results
None listed