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CompletedPhase 2

A Trial of Cilostazol in Patients With Mild Cognitive Impairment (COMCID)

A Trial of Cilostazol for Prevention of Conversion From Mild Cognitive Impairment to Dementia

Asset

Cilostazol

Listed sites

1

Recruiting sites

-

Enrollment

166

actual

Study population

MCI / preclinical Alzheimer’s

Key I/E criteria

Mild cognitive impairmentMMSE 22-28Study partner/caregiver requiredMRI contraindications excluded

Primary endpoint

Mini-Mental State Examination (MMSE)

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 IDNCT02491268
Org study IDTRINEU1321

Timeline

Milestones

Study start2015-05-01actual
Study first posted2015-07-08estimated
Primary completion2020-08-14actual
Study completion2020-12-01actual
Last update posted2020-12-04actual

Assets

Drug assets

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age84 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age between 55-84 (inclusive)

2. Study partner who sufficiently knows the daily life of the patient

3. Patients with MCI who satisfy the core clinical criteria of National Institute for Aging-Alzheimer Association for MCI (nearly equivalent to mild neurocognitive disorder in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) and who also satisfy the following three criteria:

i) Memory complaint by subject or study partner Type I: Memory complaint by subject that is verified by a study partner Type II: Otherwise, memory complaint by study partner with the evidence of memory impairment Note) Memory complaint by subject that is not verified by study partner will be excluded.

ii) Mini-Mental State Examination (MMSE) scores between 22 and 28 (inclusive) iii) Clinical Dementia Rating (CDR) = 0.5

4. Written informed consent provided for study participation

Exclusion criteria

1. Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, epilepsy, multiple sclerosis, cerebral infection, or subsequent complication caused by head trauma.

2. Findings of multiple infarction, brain tumor, or subdural hematoma on MRI performed within 48 weeks before provisional registration.

3. Contraindications for MRI such as magnetic body or metal.

4. History of major depression or bipolar disorder within 48 weeks before provisional registration, alcohol or other substance abuse within 96 weeks before provisional registration, other diseases or unstable conditions.

5. Poorly controlled diabetes mellitus (HbA1c>9.0%).

6. Cognitive impairment due to deficiency of vitamin B12 or folate.

7. Neurosyphilis.

8. Cognitive impairment due to thyroid function abnormality.

9. Psychoactive drugs within 4 weeks before provisional registration.

10. Oral anticoagulants within 4 weeks before provisional registration.

11. Double antiplatelet therapy (cf. Aspirin, Clopidogrel but not Cilostazol) within 4 weeks before provisional registration.

12. Poorly controlled diabetes mellitus treated with insulin within 4 weeks before provisional registration.

13. Episode of hypoglycemic attack with loss of consciousness within 4 weeks before provisional registration.

14. Anti-dementia drugs within 4 weeks before provisional registration.

15. Participation in any other new drug study for Alzheimer's disease.

16. Current bleeding or bleeding disorders.

17. Congestive heart failure.

18. Coronary artery stenosis.

19. Sustained high blood pressure within 2 weeks before provisional registration.

20. History of drug hypersensitivity to Cilostazol.

21. The subject or the subject's spouse pregnant or breast-feeding at the time of provisional registration.

22. Difficulty in neuropsychological tests due to hearing or visual impairment.

23. Considered by the principal investigator to be ineligible.

Endpoints (9)

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
6
Function / daily living
1
Neuroimaging
1
Other (unclassified)
1

Global cognition

6 endpoints
Primary/protocol endpoint

Change from baseline in Mini Mental State Examination (MMSE)

Time frame:96 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Cognitive Decline on Clinical dementia rating-sum of boxes (CDR-SB)

Time frame:baseline, 48 weeks, and 96 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

Cognitive Decline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) 14

Time frame:baseline, 48 weeks, and 96 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

Cognitive Decline on Logical Memory subtest of the Wechsler Memory Scale-Revised (WMS-R)

Time frame:baseline, 48 weeks, and 96 weeks

descriptive

Other/protocol endpoint

Cognitive Decline on Free and Cued Selective Reminding Test (FCSRT)

Time frame:baseline, 48 weeks, and 96 weeks

descriptive

Other/protocol endpoint

Cognitive Decline on Trail making test (TMT)

Time frame:baseline, 48 weeks, and 96 weeks

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

Functional Decline on Alzheimer's disease Cooperative Study scale for activities of daily living in MCI (ADCS-MCI-ADL)

Time frame:baseline, 48 weeks, and 96 weeks

descriptive

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Hippocampal volume

Time frame:baseline and 96 weeks

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Conversion from MCI to All-cause Dementia

Time frame:up to 96 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.