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Cilostazol Augmentation Study in Dementia

Primary Purpose

Alzheimer's Dementia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Dementia focused on measuring Alzheimer's dementia, Cilostazol

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cilostazol

Placebo

Arm Description

Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.

Placebo group means dementia patients group receiving donepezil with placebo.

Outcomes

Primary Outcome Measures

Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method
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

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)
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. Word-recall test (0-10) Commands (0-5) Constructional praxis (0-5) Naming Objects/ Fingers (0-5) Ideational Praxis (0-5) Orientation (0-8) Word Recognition (0-12) Remembering Test Instructions (0-5) Spoken Language Ability (0-5) Word Finding Difficulty (0-5) Comprehension (0-5)
Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)
Basic cognitive functions are checked. (0-30) The score is better when higher.
Activities of Daily Living (ADCS-ADL)
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)
Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms. Score Scale: 0-18 (min-MAX)
Fazekas Scale
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

Full Information

First Posted
August 3, 2011
Last Updated
April 14, 2014
Sponsor
Seoul National University Hospital
Collaborators
Korea OIAA
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1. Study Identification

Unique Protocol Identification Number
NCT01409564
Brief Title
Cilostazol Augmentation Study in Dementia
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korea OIAA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Dementia
Keywords
Alzheimer's dementia, Cilostazol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cilostazol
Arm Type
Experimental
Arm Description
Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group means dementia patients group receiving donepezil with placebo.
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method
Description
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.
Time Frame
Baseline, 24-week
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)
Description
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. Word-recall test (0-10) Commands (0-5) Constructional praxis (0-5) Naming Objects/ Fingers (0-5) Ideational Praxis (0-5) Orientation (0-8) Word Recognition (0-12) Remembering Test Instructions (0-5) Spoken Language Ability (0-5) Word Finding Difficulty (0-5) Comprehension (0-5)
Time Frame
Baseline, 12-week, 24-week
Title
Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)
Description
Basic cognitive functions are checked. (0-30) The score is better when higher.
Time Frame
Baseline, 12-month, 24-month
Title
Activities of Daily Living (ADCS-ADL)
Description
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)
Time Frame
Baseline, 12-month, 24-month
Title
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Description
Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms. Score Scale: 0-18 (min-MAX)
Time Frame
Baseline, 12-month, 24-month
Title
Fazekas Scale
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Seok Choi, MD, PhD
Organizational Affiliation
SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30761509
Citation
Lee JY, Lee H, Yoo HB, Choi JS, Jung HY, Yoon EJ, Kim H, Jung YH, Lee HY, Kim YK. Efficacy of Cilostazol Administration in Alzheimer's Disease Patients with White Matter Lesions: A Positron-Emission Tomography Study. Neurotherapeutics. 2019 Apr;16(2):394-403. doi: 10.1007/s13311-018-00708-x.
Results Reference
derived

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Cilostazol Augmentation Study in Dementia

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