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UnknownPhase 4

A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients

Asset

Choline alfoscerate

Listed sites

1

Recruiting sites

1

Enrollment

128

estimated

Study population

Alzheimer’s disease

Key I/E criterion

MMSE 12-24

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

Org study IDDWB_GTM001
NCT IDNCT02648906

Timeline

Milestones

Study start2015-07 (month precision)
Study first posted2016-01-07estimated
Last update posted2016-11-02estimated
Primary completion2018-11estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age56 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. 56~90 male and female

2. Mini-Mental State Evaluation (MMSE) between 24 and 12

3. Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI

4. Score 0.5, 1, 2 at CDR

5. presence of at least two of the following vascular risk factors: hypertension, diabetes, obesity, ischemic heart disease, dyslipidemia, hyperhomocysteinemia, smoking, previous cerebrovascular events and familiar history of cardio-cerebrovascular diseases.

6. donepezil 10mg from 3 months ago, dose not changed during clinical trials

7. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion criteria

1. Subjects allergic to or sensitive to the Investigational Product or applicable ingredients

2. subject who has taken below medication 1 month before screening 1) Cholinesterase Inhibitors 2) NMDA receptor antagonists 3) blood circulation supplements 4) Acetyl-L-Carnitines 5) Nicergoline 6) Subject who has taken another medication that can affect the result of primary outcome

3. subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc.

4. Asthma, COPD

5. Decompensated heart disease

6. Chronic renal failure or chronic liver disease

7. Malignant tumor

8. Subject that cant' be followed up for 12 months after Investigational drug was taken.

9 Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods 10. Subject who has taken other clinical or licensed medication from another clinical trial within 30 days prior screening period 11.Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator

Endpoints (1)

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.

Global cognition

1 endpoint
Primary/protocol endpoint

change of ADAS-cog score compared with Baseline

Time frame:48 weeks

ADAS-Cog

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.