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Cilostazol Augmentation Study in Dementia

This study has been completed.
Sponsor:
Collaborator:
Korea OIAA
Information provided by (Responsible Party):
Jung-Seok Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01409564
First received: August 3, 2011
Last updated: April 14, 2014
Last verified: April 2014

August 3, 2011
April 14, 2014
May 2010
June 2012   (final data collection date for primary outcome measure)
Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method [ Time Frame: Baseline, 24-week ] [ Designated as safety issue: No ]
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.
VBM based Brain Positron Emission Tomography (PET) change [ Time Frame: Baseline, 6-month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01409564 on ClinicalTrials.gov Archive Site
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) [ Time Frame: Baseline, 12-week, 24-week ] [ Designated as safety issue: No ]

    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)
  • Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet) [ Time Frame: Baseline, 12-month, 24-month ] [ Designated as safety issue: No ]
    Basic cognitive functions are checked. (0-30) The score is better when higher.
  • Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, 12-month, 24-month ] [ Designated as safety issue: No ]

    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)

  • Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) [ Time Frame: Baseline, 12-month, 24-month ] [ Designated as safety issue: No ]

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

    Score Scale: 0-18 (min-MAX)

  • Fazekas Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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

  • 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 ]
Not Provided
Not Provided
 
Cilostazol Augmentation Study in Dementia
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Dementia
  • 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.
  • 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.
  • Experimental: Cilostazol
    Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
    Intervention: Drug: Cilostazol
  • Placebo Comparator: Placebo
    Placebo group means dementia patients group receiving donepezil with placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01409564
06-2009-145
Not Provided
Jung-Seok Choi, Seoul National University Hospital
Seoul National University Hospital
Korea OIAA
Principal Investigator: Jung-Seok Choi, MD, PhD SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
Seoul National University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP