Cilostazol Augmentation Study in Dementia

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Alzheimer's Dementia

Treatments

Drug: Placebo

Drug: Cilostazol

Study type

Interventional

Funder types

Other

Identifiers

NCT01409564

06-2009-145

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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