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