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Cilostazol Augmentation Study in Dementia

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ClinicalTrials.gov Identifier: NCT01409564
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Korea OIAA
Information provided by (Responsible Party):
Jung-Seok Choi, Seoul National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Dementia Drug: Cilostazol Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method [ Time Frame: Baseline, 24-week ]
    Regional cerebral glucose uptake level was measured as the ratio value of FDG uptake of the each unit level to the global mean uptake value.

Secondary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) [ Time Frame: Baseline, 12-week, 24-week ]

    The ADAS-Cog score is measured by the number of questions answered incorrectly, therefore the higher is the worse.

    Score Scale: 0-75 (min-MAX)

    Each subcategory scores are summed.

    1. Word-recall test (0-10)
    2. Commands (0-5)
    3. Constructional praxis (0-5)
    4. Naming Objects/ Fingers (0-5)
    5. Ideational Praxis (0-5)
    6. Orientation (0-8)
    7. Word Recognition (0-12)
    8. Remembering Test Instructions (0-5)
    9. Spoken Language Ability (0-5)
    10. Word Finding Difficulty (0-5)
    11. Comprehension (0-5)

  2. Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet) [ Time Frame: Baseline, 12-month, 24-month ]
    Basic cognitive functions are checked. (0-30) The score is better when higher.

  3. Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, 12-month, 24-month ]

    The caregiver answered to the questions given to measure the cognitive function level of the patients in daily living. Lower scores indicate greater severity.

    23 questions Score Scale: 0-78 (min-MAX)

  4. Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 12-month, 24-month ]

    Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms.

    Score Scale: 0-18 (min-MAX)

  5. Fazekas Scale [ Time Frame: Baseline ]

    Level of severity of white matter lesions in AD patients who can be legitimately administered with cilostazol. Measured by professionally trained clinicians.

    The higher score indicates more severe white matter lesion. Max-min: 0-3

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409564

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Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
Korea OIAA
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Principal Investigator: Jung-Seok Choi, MD, PhD SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jung-Seok Choi, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01409564    
Other Study ID Numbers: 06-2009-145
First Posted: August 4, 2011    Key Record Dates
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014
Last Verified: April 2014
Keywords provided by Jung-Seok Choi, Seoul National University Hospital:
Alzheimer's dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors