A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy and safety of Choline alfoscerate and Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer patients

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: Choline alfoscerate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 56 90 male and female Mini-Mental State Evaluation (MMSE) between 24 and 12 Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI Score 0.5, 1, 2 at CDR presence of at least two of the following vascular risk factors: hypertension, diabetes, obesity, ischemic heart disease, dyslipidemia, hyperhomocysteinemia, smoking, previous cerebrovascular events and familiar history of cardio-cerebrovascular diseases. donepezil 10mg from 3 months ago, dose not changed during clinical trials A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints Exclusion Criteria: Subjects allergic to or sensitive to the Investigational Product or applicable ingredients subject who has taken below medication 1 month before screening 1) Cholinesterase Inhibitors 2) NMDA receptor antagonists 3) blood circulation supplements 4) Acetyl-L-Carnitines 5) Nicergoline 6) Subject who has taken another medication that can affect the result of primary outcome subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc. Asthma, COPD Decompensated heart disease Chronic renal failure or chronic liver disease Malignant tumor Subject that cant' be followed up for 12 months after Investigational drug was taken. 9 Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods 10. Subject who has taken other clinical or licensed medication from another clinical trial within 30 days prior screening period 11.Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator

Ages Eligible for Study
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Minimum Age: 56 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choline alfoscerate<br>Drug: Choline alfoscerate and Donepezil concomitant administration | Drug: Choline alfoscerate<br> <br> |
| Placebo Comparator: Placebo<br>Drug: Donepezil only | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of ADAS-cog score compared with Baseline | Primary outcome will be evaluated with ADAS-cog questionnaire 48 weeks after taking investigational product. | 48 weeks |