Status:
UNKNOWN
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia
Lead Sponsor:
Yuhan Corporation
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE4
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03441516
Start Date
April 19 2018
End Date
December 31 2021
Last Update
December 22 2020
Active Locations (6)
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1
Dong-A University Hospital
Busan, South Korea
2
Gyeongsang National University Hospital
Busan, South Korea
3
Inje University Busan Paik Hospital
Busan, South Korea
4
Inje University Haeundae Paik Hospital
Busan, South Korea