UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000449 |
|---|---|
| Receipt number | R000000545 |
| Scientific Title | Prevention traial of dementia using nonpharmacological interventions in Mild Cognitive Impairment (MCI) among the community-dwelling elderly |
| Date of disclosure of the study information | 2006/07/15 |
| Last modified on | 2006/07/14 12:04:42 |
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Basic information
Public title
Prevention traial of dementia using nonpharmacological interventions in Mild Cognitive Impairment (MCI) among the community-dwelling elderly
Acronym
Ajimu Project
Scientific Title
Prevention traial of dementia using nonpharmacological interventions in Mild Cognitive Impairment (MCI) among the community-dwelling elderly
Scientific Title:Acronym
Ajimu Project
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment (MCI)
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of this study is to evaluate the effect of nonpharmacological intervention to prevent dementia in community-dwelling MCI subjects of Ajimu town.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The subject is observed cognitive functions using "Five-Cog", a neuropsychological assessment comprised of five categories: memory, attention, verbal fluency, clock drawing test, and analogy. This examination is evaluated every one year.
Key secondary outcomes
Brain perfusion SPECT study, MMSE, CDR, WMS-R (logical memory I)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group attend the occupational therapy and aerobic therapy once a week for three years.
Interventions/Control_2
Non-intervention group attend a dementia enlightenment lectuer once a year and live ordinary life.
Interventions/Control_3
Control group does not attend dementia prevention program at all and lives a conventional life.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The MCI subjects were selected from community-dwellers aged 65 years or above in Ajimu, Japan. The subject was defined as amnestic subtypes of MCI according to the criteria of the follows; insidious onset and gradual progression, impaired memory, the 32 words delayed recall score 1.0 SD below an education adjusted norm, a Clinical Dementia Rating (CDR) of 0.5, a score of 24 to 30 on the Mini-Mental State Examination (MMSE), and age of 65 years or above.
Key exclusion criteria
1.Patients of
(1)Ischemic heart disease
(2)Dementia
2.Persons with mental problems
3.Pregnant women
4.Persons who are not adequate for the research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Yamada |
Organization
Fukuoka University
Division name
Fifth Department of Internal Medicine
Zip code
Address
45-1, Nanakuma7, Johnanku, Fukuoka, Japan
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Yamada |
Organization
Fukuoka University
Division name
Fifth Department of Internal Medicine
Zip code
Address
45-1, Nanakuma7, Johnanku, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
tyamada@fukuoka-u.ac.jp
Sponsor or person
Institute
Fifth Department of Internal Medicine, School of Medicine, Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Research grants from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 07 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2003 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 07 | Month | 14 | Day |
Last modified on
| 2006 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000545
