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

Alzheimer's Disease Clinical Trial

— ALFO-AD  

Official title:

Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia: A Multi-center, Randomized, Open-label, Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03441516
• Other study ID #: YMC034
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 19, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 79
• Est. completion date: December 31, 2021
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• Alfoatirin® Tab. + Aripezil® Tab.
Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks
• Aripezil® Tab.
Donepezil 10 mg Oral Tablet qd for 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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