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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005458
Receipt No. R000006005
Scientific Title A study on the relationship between sleep architecture and transition to Alzheimer' s disease in patients with MCI
Date of disclosure of the study information 2011/04/18
Last modified on 2011/04/18

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Basic information
Public title A study on the relationship between sleep architecture and transition to Alzheimer' s disease in patients with MCI
Acronym A study on sleep architecture in MCI
Scientific Title A study on the relationship between sleep architecture and transition to Alzheimer' s disease in patients with MCI
Scientific Title:Acronym A study on sleep architecture in MCI
Region
Japan

Condition
Condition Mild cognitive impairment
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the association between the cognitive declines and sleep architecture in MCI.
Basic objectives2 Others
Basic objectives -Others factors affecting prognosis
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes polysomnography
Key secondary outcomes MMSE, NINCDS-ADRDA, ADAS

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Mild cognitive impairment (MCI)
Key exclusion criteria major medical illness
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideto Shinno
Organization Kagawa University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL +81-87-891-2165
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideto Shinno
Organization Kagawa University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL +81-87-891-2165
Homepage URL
Email shinnoh@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa 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 香川大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 18 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 Enrolling by invitation
Date of protocol fixation
2011 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information a prospective study evaluating the emergence of Alzheimer's disease

Management information
Registered date
2011 Year 04 Month 18 Day
Last modified on
2011 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006005

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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