UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005458 |
|---|---|
| Receipt number | 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 13:00:31 |
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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
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
shinnoh@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006005
