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

Phase 4

• Conditions: Alzheimer's Disease
• Interventions: Drug: Alfoatirin® Tab. + Aripezil® Tab.; Drug: Aripezil® Tab.

• Registration Number: NCT03441516
• Lead Sponsor: Yuhan Corporation

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-22
• Study Start: 2018-04-19
• Primary Completion: 2019-07-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-20
• Last Update Posted: 2020-12-22
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alfoatirin® Tab. + Aripezil® Tab.	Alfoatirin® Tab. + Aripezil® Tab.	Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks
Aripezil® Tab.	Aripezil® Tab.	Donepezil 10mg qd for 24 weeks

Primary Outcome Measures

Name	Time	Method
ADAS-cog	At 24 weeks	To evaluate cognitive function

Secondary Outcome Measures

Name	Time	Method
K-MMSE (Korean version of Mini-Mental State Examination)	At 12 and 24 weeks	To evaluate cognitive function
FAB (Frontal Assessment Battery)	At 12 and 24 weeks	To evaluate frontal lobe dysfunction
ADAS-cog	At 12 weeks	To evaluate cognitive function
CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)	At 12 and 24 weeks	To evaluate neuropsychiatric symptom in dementia
S-IADL (Seoul-Instrumental Activities of Daily Living)	At 12 and 24 weeks	To evaluate daily activities of living
Changes in brain metabolism by F-18 FDG brain PET	At 24 weeks

Trial Locations

Locations (6)

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Busan, Korea, Republic of

Samsung Changwon Hospital; 🇰🇷 Busan, Korea, Republic of