Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT02491268
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
84 Years
Study:
NCT02491268
Study Brief:
Protocol Section:
NCT02491268