ALFO-AD

UnknownPhase 4

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

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

Lead sponsor

Yuhan Corporation

Assets

Choline alfoscerate / Donepezil / Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•CDR global 0.5-2•MMSE 12-26•AD symptomatic therapy: stable ≥2 weeks

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03441516

Org study IDYMC034

Timeline

Milestones

Study first posted2018-02-22actual

Study start2018-04-19actual

Primary completion2019-07-04actual

Last update posted2020-12-22actual

Study completion2021-12-31estimated

Assets

Drug assets

Choline alfoscerate / Donepezil Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Executive function / language

Function / daily living

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

3 endpoints

Primary/protocol endpoint

ADAS-cog

Time frame:At 24 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

ADAS-cog

Time frame:At 12 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

K-MMSE (Korean version of Mini-Mental State Examination)

Time frame:At 12 and 24 weeks

Mini-Mental State Examination (MMSE)

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

FAB (Frontal Assessment Battery)

Time frame:At 12 and 24 weeks

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

S-IADL (Seoul-Instrumental Activities of Daily Living)

Time frame:At 12 and 24 weeks

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

CGA-NPI (Caregiver-Administered Neuropsychiatric Inventory)

Time frame:At 12 and 24 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Changes in brain metabolism by F-18 FDG brain PET

Time frame:At 24 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.