Cilostazol Augmentation Study in Dementia
This study is currently recruiting participants.
Verified August 2011 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Collaborator:
Korea OIAA
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01409564
First received: August 3, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Dementia |
Drug: Cilostazol Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- VBM based Brain Positron Emission Tomography (PET) change [ Time Frame: Baseline, 6-month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
- Mini-Mental State Examination [ Time Frame: baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
- Caregiver-Administered Neuropsychiatric Inventory (NPI) [ Time Frame: baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
- Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) [ Time Frame: baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cilostazol
Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
|
Drug: Cilostazol
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 Comparator: Placebo
Placebo group means dementia patients group receiving donepezil with placebo.
|
Drug: Placebo
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.
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409564
Contacts
| Contact: Jung-Seok Choi, MD, PhD | 82-2-870-3461 | choijs@neuroimage.snu.ac.kr |
Locations
| Korea, Republic of | |
| SMG-SNU Boramae Medical Center | Recruiting |
| Seoul, Korea, Republic of, 156-707 | |
| Contact: Jung-Seok Choi, MD, PhD 82-2-870-3461 choijs@neuroimage.snu.ac.kr | |
| Sub-Investigator: Jun Young Lee, MD, PhD | |
| Sub-Investigator: Hee Yeon Jung, MD, PhD | |
| Sub-Investigator: Hae Woo Lee, MD | |
| Sub-Investigator: Ho-Young Lee, MD, PhD | |
| Principal Investigator: Jung-Seok Choi, MD, PhD | |
Sponsors and Collaborators
Seoul National University Hospital
Korea OIAA
Investigators
| Principal Investigator: | Jung-Seok Choi, MD, PhD | SMG-SNU Boramae Medical Center, Seoul, Republic of Korea |
More Information
No publications provided
| Responsible Party: | Jung Seok Choi, SMG-SNU Boramae Medical Center |
| ClinicalTrials.gov Identifier: | NCT01409564 History of Changes |
| Other Study ID Numbers: | 06-2009-145 |
| Study First Received: | August 3, 2011 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Hospital:
|
Alzheimer's dementia Cilostazol |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cilostazol Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents |
Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Vasodilator Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013