Clinical trial NCT03441516: Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia
Official title: Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia: A Multi-center, Randomized, Open-label, Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 79
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: ADAS-cog
timeFrame: At 24 weeks
Secondary outcomes:
measure: ADAS-cog
timeFrame: At 12 weeks
measure: K-MMSE (Korean version of Mini-Mental State Examination)
timeFrame: At 12 and 24 weeks
measure: FAB (Frontal Assessment Battery)
timeFrame: At 12 and 24 weeks
measure: S-IADL (Seoul-Instrumental Activities of Daily Living)
timeFrame: At 12 and 24 weeks
measure: CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)
timeFrame: At 12 and 24 weeks
measure: Changes in brain metabolism by F-18 FDG brain PET
timeFrame: At 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Busan
country: Korea, Republic of
facility: Samsung Changwon Hospital
Study officials:
References: