Cilostazol Augmentation Study in Dementia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
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
  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 April 16, 2014