Back to resultsEffect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia (ALFO-AD)
Primary Purpose
Alzheimer's Disease
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Alfoatirin® Tab. + Aripezil® Tab.
Aripezil® Tab.
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
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
Sites / Locations
- Dong-A University Hospital
- Gyeongsang National University Hospital
- Inje University Busan Paik Hospital
- Inje University Haeundae Paik Hospital
- Pusan National University Yangsan Hospital
- Samsung Changwon Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alfoatirin® Tab. + Aripezil® Tab.
Aripezil® Tab.
Arm Description
Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks
Donepezil 10mg qd for 24 weeks
Outcomes
Primary Outcome Measures
ADAS-cog
To evaluate cognitive function
Secondary Outcome Measures
ADAS-cog
To evaluate cognitive function
K-MMSE (Korean version of Mini-Mental State Examination)
To evaluate cognitive function
FAB (Frontal Assessment Battery)
To evaluate frontal lobe dysfunction
S-IADL (Seoul-Instrumental Activities of Daily Living)
To evaluate daily activities of living
CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)
To evaluate neuropsychiatric symptom in dementia
Changes in brain metabolism by F-18 FDG brain PET
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03441516
Brief Title
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia
Acronym
ALFO-AD
Official Title
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia: A Multi-center, Randomized, Open-label, Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
July 4, 2019 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alfoatirin® Tab. + Aripezil® Tab.
Arm Type
Experimental
Arm Description
Choline Alphoscerate 400mg bid + Donepezil 10mg qd for 24 weeks
Arm Title
Aripezil® Tab.
Arm Type
Active Comparator
Arm Description
Donepezil 10mg qd for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Alfoatirin® Tab. + Aripezil® Tab.
Intervention Description
Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Aripezil® Tab.
Intervention Description
Donepezil 10 mg Oral Tablet qd for 24 weeks
Primary Outcome Measure Information:
Title
ADAS-cog
Description
To evaluate cognitive function
Time Frame
At 24 weeks
Secondary Outcome Measure Information:
Title
ADAS-cog
Description
To evaluate cognitive function
Time Frame
At 12 weeks
Title
K-MMSE (Korean version of Mini-Mental State Examination)
Description
To evaluate cognitive function
Time Frame
At 12 and 24 weeks
Title
FAB (Frontal Assessment Battery)
Description
To evaluate frontal lobe dysfunction
Time Frame
At 12 and 24 weeks
Title
S-IADL (Seoul-Instrumental Activities of Daily Living)
Description
To evaluate daily activities of living
Time Frame
At 12 and 24 weeks
Title
CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)
Description
To evaluate neuropsychiatric symptom in dementia
Time Frame
At 12 and 24 weeks
Title
Changes in brain metabolism by F-18 FDG brain PET
Time Frame
At 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Samsung Changwon Hospital
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Choline Alphoscerate on Cognitive Function in Alzheimer's Dementia
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