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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Choline; Donepezil

Criteria

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