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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006599
Receipt No. R000007736
Scientific Title Evaluation of effect of cilostazol on cerebral glucose metabolism in patients with amnestic mild cognitive impairment and preclinical Alzheimer's disease with lacunar infarction.
Date of disclosure of the study information 2011/10/25
Last modified on 2014/10/24

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Basic information
Public title Evaluation of effect of cilostazol on cerebral glucose metabolism in patients with amnestic mild cognitive impairment and preclinical Alzheimer's disease with lacunar infarction.
Acronym Effect of cilostazol on cerebral glucose metabolism in preclinical Alzheimer's disease
Scientific Title Evaluation of effect of cilostazol on cerebral glucose metabolism in patients with amnestic mild cognitive impairment and preclinical Alzheimer's disease with lacunar infarction.
Scientific Title:Acronym Effect of cilostazol on cerebral glucose metabolism in preclinical Alzheimer's disease
Region
Japan

Condition
Condition amnestic mild cognitive impairment and preclinical Alzheimer's disease
Classification by specialty
Neurology Geriatrics Psychiatry
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluation of effect monotherapy of cilostazol on cognitive function and cerebral glucose metabolism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MMSE,WMS-R,FDG-PET
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cilostazol 100mg daily for 3 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria MMSE 24-30
Key exclusion criteria other anti-dementia drugs
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuneyoshi Ota
Organization Juntendo University Hospital
Division name Department of Psychiatry
Zip code
Address 2-1-1. Hongo, Bunkyo-city, Tokyo 113-8421, Japan
TEL 03-3813-3111
Email ota@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuneyoshi Ota
Organization Juntendo University School of Medicine
Division name Department of Psychiatry
Zip code
Address 2-1-1. Hongo, Bunkyo-city, Tokyo 113-8421, Japan
TEL 03-3813-3111
Homepage URL
Email ota@juntendo.ac.jp

Sponsor
Institute Department of Psychiatry,
Juntendo University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 24 Day
Last modified on
2014 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007736

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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