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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 impairment•MMSE 22-28•Study partner/caregiver required•MRI 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsChange from baseline in Mini Mental State Examination (MMSE)
Time frame:96 weeks
Mini-Mental State Examination (MMSE)
change from baseline, improvement
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
Cognitive Decline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) 14
Time frame:baseline, 48 weeks, and 96 weeks
ADAS-Cog
descriptive
Cognitive Decline on Logical Memory subtest of the Wechsler Memory Scale-Revised (WMS-R)
Time frame:baseline, 48 weeks, and 96 weeks
descriptive
Cognitive Decline on Free and Cued Selective Reminding Test (FCSRT)
Time frame:baseline, 48 weeks, and 96 weeks
descriptive
Cognitive Decline on Trail making test (TMT)
Time frame:baseline, 48 weeks, and 96 weeks
descriptive
Function / daily living
1 endpointFunctional 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 endpointHippocampal volume
Time frame:baseline and 96 weeks
descriptive
Other (unclassified)
1 endpointConversion 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.
Registry references + supporting bibliography
- PMID38048134via DERIVED
Provenance
Sources
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.