Mild cognitive impairment (MCI)
Conditions
Interventions
After the registration, the Site Investigators should start protocol treatment within 28 days including the day of registration. Protocol treatment defines as follows
Investigational Treatment: Cilostazol 50mg B.I.D. p.o. 96 Weeks
After the registration, the Site Investigators should start protocol treatment within 28 days including the day of registration. Proto
Comparative Treatment: Placebo B.I.D. p.o. 96 Weeks
Sponsors
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age between 55-84 (inclusive) 2) Study partner who lives with subject available for all visits 3) Patients with MCI who satisfy the core clinical criteria of NIA/AA for MCI (nearly equivalent to mild neurocognitive disorder in DSM-5) 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
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%) within 24 weeks before provisional registration. 6) Cognitive impairment due to deficiency of vitamin B12 or folate. 7) Neurosyphilis. 8) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Cilostazol with respect to the cognitive function measured by MMSE in patients with MCI (mild cognitive impairment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the efficacy of Cilostazol in preventing conversion from MCI to All-cause Dementia. 2.To evaluate the efficacy of Cilostazol with respect to the cognitive function measured by CDR-SB in patients with MCI. 3.To evaluate the efficacy of Cilostazol with respect to the cognitive function measured by ADAS-Cog 14 in patients with MCI. 4.To evaluate the efficacy of Cilostazol with respect to the cognitive function measured by the Logical Memory subtest of the Wechsler Memory Scale-Revised (WMS-R) in patients with MCI. 5.To evaluate the efficacy of Cilostazol with respect to the activity of daily living measured by Alzheimer's Disease Cooperative Study - Activities of Daily Living in MCI (ADCS-MCI-ADL). 6.To evaluate the efficacy of Cilostazol with respect to the brain atrophy measured by brain MRI in patients with MCI. | — |
Countries
Japan
Contacts
Public ContactRyosuke Kakuta
National Cerebral and Cardiovascular Center Division of Neurology
Outcome results
None listed