Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia (ALFO-AD)

Yuhan

Status and phase

Unknown

Phase 4

Conditions

Alzheimer's Disease

Treatments

Drug: Aripezil® Tab.

Drug: Alfoatirin® Tab. + Aripezil® Tab.

Study type

Interventional

Funder types

Industry

Identifiers

NCT03441516

YMC034

Details and patient eligibility

About

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

Enrollment

79 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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