Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia

Study Overview
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Brief Summary
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This study will evaluate the performance of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) in patients with Alzheimer's disease (AD).

Official Title
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Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia: A Multi-center, Randomized, Open-label, Pilot Study

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Alfoatirin® Tab. + Aripezil® Tab.
* Drug: Aripezil® Tab.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alfoatirin® Tab. + Aripezil® Tab.<br>Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks | Drug: Alfoatirin® Tab. + Aripezil® Tab.<br>* Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks<br>|
| Active Comparator: Aripezil® Tab.<br>Donepezil 10mg qd for 24 weeks | Drug: Aripezil® Tab.<br>* Donepezil 10 mg Oral Tablet qd for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog | To evaluate cognitive function | At 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog | To evaluate cognitive function | At 12 weeks | 
| K-MMSE (Korean version of Mini-Mental State Examination) | To evaluate cognitive function | At 12 and 24 weeks | 
| FAB (Frontal Assessment Battery) | To evaluate frontal lobe dysfunction | At 12 and 24 weeks | 
| S-IADL (Seoul-Instrumental Activities of Daily Living) | To evaluate daily activities of living | At 12 and 24 weeks | 
| CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory) | To evaluate neuropsychiatric symptom in dementia | At 12 and 24 weeks | 
| Changes in brain metabolism by F-18 FDG brain PET |  | At 24 weeks |