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Cilostazol Augmentation Study in Dementia

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Dementia

Intervention: Cilostazol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jung-Seok Choi, MD, PhD, Principal Investigator, Affiliation: SMG-SNU Boramae Medical Center, Seoul, Republic of Korea


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.

Clinical Details

Official title: Cilostazol Augmentation Study In Dementia (CASID): A Randomized, Placebo-controlled Pilot Study to Compare the Efficacy Between Donepezil Monotherapy and Cilostazol Augmentation Therapy in Alzheimer's Disease Patients With Subcortical White Matter Hyperintensities

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method

Secondary outcome:

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)

Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)

Activities of Daily Living (ADCS-ADL)

Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)

Fazekas Scale


Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

SMG-SNU Boramae Medical Center, Seoul 156-707, Korea, Republic of
Additional Information

Starting date: May 2010
Last updated: April 14, 2014

Page last updated: August 23, 2015

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