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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
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer's Dementia
Interventions: Drug: Cilostazol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
46 Subjects were enrolled in the single center of Seoul National University Boramae Hospital. The diagnosis of probable AD was made according to the criteria of NINCDS-ADRDA (MMSE score 10 ~ 26). Enrollment has started in July 2010 to end in March 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cilostazol Cilostazol group includes dementia patients receiving donepezil with cilostazol augmentation. All the randomly assigned AD patients in cilostazol group received 10 mg of Donepezil along with 200 mg of cilostazol per a day, doubly blinded. All the medications were orally administered. For the initial two weeks, patients only received 100 mg of cilstazol per a day to minimize the instabilities. Afterwards, for 22 weeks, patients received 200 mg of cilostazol.
Placebo Placebo group includes dementia patients receiving donepezil with placebo. All the patients were randomly assigned as placebo group and received 10 mg of Donepezil along with the same dose of sugar pill as normal cilostazol. All the clinical assessments and medications were doubly blinded. All the medications were orally administered.

Participant Flow:   Overall Study
    Cilostazol     Placebo  
STARTED     23     23  
COMPLETED     18     18  
NOT COMPLETED     5     5  
low medication compliance                 4                 3  
brain abnormalities found in T1 MR                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
18 subjects for each group were enrolled in the final list.

Reporting Groups
  Description
Cilostazol Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
Placebo Placebo group means dementia patients group receiving donepezil with placebo.
Total Total of all reporting groups

Baseline Measures
    Cilostazol     Placebo     Total  
Number of Participants  
[units: participants]
  18     18     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     18     18     36  
Age  
[units: years]
Mean ± Standard Deviation
  79.00  ± 6.26     78.05  ± 6.09     78.53  ± 6.11  
Gender  
[units: participants]
     
Female     13     15     28  
Male     5     3     8  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     18     18     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method   [ Time Frame: Baseline, 24-week ]

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

3.  Secondary:   Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)   [ Time Frame: Baseline, 12-month, 24-month ]

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

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

6.  Secondary:   Fazekas Scale   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Jung Seok Choi
Organization: Seoul National University Hospital
phone: 82-2-870-3461
e-mail: choijs@neuroimage.snu.ac.kr


No publications provided


Responsible Party: Jung-Seok Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01409564     History of Changes
Other Study ID Numbers: 06-2009-145
Study First Received: August 3, 2011
Results First Received: August 19, 2013
Last Updated: April 14, 2014
Health Authority: Korea: Food and Drug Administration