A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients
NCT ID: NCT02648906
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
128 participants
INTERVENTIONAL
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Choline alfoscerate
Drug: Choline alfoscerate and Donepezil
concomitant administration
Choline alfoscerate
Placebo
Drug: Donepezil only
Placebo
Interventions
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Choline alfoscerate
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Mini-Mental State Evaluation (MMSE) between 24 and 12
3. Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI
4. Score 0.5, 1, 2 at CDR
5. 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.
6. donepezil 10mg from 3 months ago, dose not changed during clinical trials
7. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
Exclusion Criteria
2. 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
3. subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc.
4. Asthma, COPD
5. Decompensated heart disease
6. Chronic renal failure or chronic liver disease
7. Malignant tumor
8. 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
56 Years
90 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Bundang Hospital
Sungnam, , South Korea
Countries
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Central Contacts
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Other Identifiers
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DWB_GTM001
Identifier Type: -
Identifier Source: org_study_id