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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000449
Receipt No. 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

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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
Email

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
Email tyamada@fukuoka-u.ac.jp

Sponsor
Institute Fifth Department of Internal Medicine, School of Medicine, Fukuoka University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000545

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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