Cilostazol Augmentation Study in Dementia
Condition: Alzheimer's Dementia
MeSH terms: Dementia; Alzheimer Disease
Intervention: Cilostazol; Placebo
Intervention description: Cilostazol 100mg bid per day will be administered orally and the period is total 24 weeks. The first week is a period for increasing the quantity, and during this period, cilostazol 50mg bid per day will be administered orally.; Placebo with similar shape and color to cilostazol 100mg bid per day will be administered orally and the period is total 24 weeks. The first week is a period for increasing the quantity, and during this period, placebo 50mg bid per day will be administered orally.
Intervention MeSH terms: Cilostazol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Alzheimer's dementia; Cilostazol

Summary:

      The purpose of this study is to examine the effects of cilostazol augmentation in mild to
      moderate Alzheimer disease patients with subcortical white matter hyperintensities (WMHI)
      treated by donepezil.

      Dementia is the most disabling disease in the old age. The prevalence of dementia is 5-10% of
      the elders. AchEIs (donepezil, galantamine, rivastigmine) are used to treat mild to moderate
      dementia, but these drugs only relate to symptomatic improvement and the response rates are
      less than 30%.

      Cilostazol is a cyclic adenosine monophosphate phosphodiesterase 3 inhibitor (PDE3I) and used
      as antiplatelet agent in subcortical vascular disease (WMHI). And it upregulates
      phosphorylation of cyclic adenosine monophosphate-pathway response element binding protein
      (CREB) which plays a crucial role in memory enhancement and synaptic plasticity related to
      neurodegeneration prevention.

      The investigators will try cilostazol augmentation in dementia patients with WMHI receiving
      donepezil to see the addictive effects of cilostazol using cognitive tasks and PET imaging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men/women over sixty years old

          -  Patients with slight and moderate dementia (MMSE score is over 10 under 26.)

          -  Patients with probable Alzheimer's disease according to the standard of NINCDS-ADRDA

          -  Patients accompanied with WMHI on Brain MRI (Fazeka's scale 1~3)

        Exclusion Criteria:

          -  Those who do not agree to the test in a written form

          -  Patients who accompany other diseases except cerebral atrophy or change of subcortical
             white matter due to Alzheimer's disease on brain MRI

          -  Patients who should not use Cilostazol (① patients with bleeding tendency ② patients
             with congestive heart failure ③ patients who have a medical history of
             hypersensitivity to this medicine or constituent of this medicine ④ those who use
             anticoagulant and clot buster)

          -  Patients who suffer from nerve diseases or mental diseases which have influence on
             cognitive function except Alzheimer's disease (for example, schizophrenia, severe
             depression, mental retardation and etc.)

          -  Patients who are suspected to have a personal history of drug addiction or alcoholism
             within recent 10 years

          -  Patients who have severe problems in eye sight or hearing so that it is impossible to
             conduct the test smoothly

          -  Patients who the researchers think are inappropriate for taking part in the test