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

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

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

Study Overview

• Status: Unknown
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Alfoatirin® Tab. + Aripezil® Tab.; Drug: Aripezil® Tab.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Busan, Korea, Republic of
    • Inje University Haeundae Paik Hospital
  • Busan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Busan, Korea, Republic of
    • Gyeongsang National University Hospital
  • Busan, Korea, Republic of
    • Samsung Changwon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alfoatirin® Tab. + Aripezil® Tab.; Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks	Drug: Alfoatirin® Tab. + Aripezil® Tab.; Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks
Active Comparator: Aripezil® Tab.; Donepezil 10mg qd for 24 weeks	Drug: Aripezil® Tab.; Donepezil 10 mg Oral Tablet qd for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADAS-cog	To evaluate cognitive function	At 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): July 4, 2019
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: YMC034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No