Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia
NCT ID: NCT03441516
Last Updated: 2020-12-22
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
79 participants
INTERVENTIONAL
2018-04-19
2021-12-31
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
NONE
Study Groups
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Alfoatirin® Tab. + Aripezil® Tab.
Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks
Alfoatirin® Tab. + Aripezil® Tab.
Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks
Aripezil® Tab.
Donepezil 10mg qd for 24 weeks
Aripezil® Tab.
Donepezil 10 mg Oral Tablet qd for 24 weeks
Interventions
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Alfoatirin® Tab. + Aripezil® Tab.
Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks
Aripezil® Tab.
Donepezil 10 mg Oral Tablet qd for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
90 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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Dong-A University Hospital
Busan, , South Korea
Gyeongsang National University Hospital
Busan, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Pusan National University Yangsan Hospital
Busan, , South Korea
Samsung Changwon Hospital
Busan, , South Korea
Countries
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Other Identifiers
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YMC034
Identifier Type: -
Identifier Source: org_study_id