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

Y

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

79 participants in 2 patient groups

Alfoatirin® Tab. + Aripezil® Tab.
Experimental group
Description:
Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks
Treatment:
Drug: Alfoatirin® Tab. + Aripezil® Tab.
Aripezil® Tab.
Active Comparator group
Description:
Donepezil 10mg qd for 24 weeks
Treatment:
Drug: Aripezil® Tab.

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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