UMIN-CTR Clinical Trial

Basic information
Public title	A randomized control trial for preventing decline of cognitive functions in the community living elderly with mild cognitive impairment
Acronym	A randomized control trial for preventing decline of cognitive functions in the elderly with MCI
Scientific Title	A randomized control trial for preventing decline of cognitive functions in the community living elderly with mild cognitive impairment
Scientific Title:Acronym	A randomized control trial for preventing decline of cognitive functions in the elderly with MCI
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of physical exercise on cognitive decline in elderly with mild cognitive impairment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function: ADAS Brain volumetry: MRI Brain function: FDG PET and fNIRS
Key secondary outcomes	Cognitive functions: Mini-mental state examination, Clinical dementia rating, Wechsler memory scale-R, Digit span, Stroop test, SDMT, Word fluency, Trail making test, Geriatric depression scale, Clock drawing, VBTA, Ray-Osterrieth complex figure test, Raven's Colored Progressive Matrices, Key search test, A part of standard language test of aphasia Physical functions: muscle strength, gait performance Activity: Tokyo Metropolitan Institute of Gerontology Index, Life-space assessment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: Supervised aerobic exercise for 1 year
Interventions/Control_2	Control group: Lecture about disease and health (3 times per year)
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Living in Obu city 2) CDR 0.5 3) give a written informed consent to the participation in the present study
Key exclusion criteria	1) Having serious or unstable illnesses 2) history of psychiatric disease 3) Receiving of anti-Alzheimer drugs
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Suzuki Takao
Organization	National Center for Geriatrics and Gerontology
Division name	Research Institute
Zip code
Address	35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Shimada Hiroyuki
Organization	National Center for Geriatrics and Gerontology
Division name	Section for Health Promotion
Zip code
Address	35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL
Homepage URL
Email	shimada@ncgg.or.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	Obu city
Organization
Division
Category of Funding Organization	Local Government
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	NPOネットワーク大府

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

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	2010 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 05 Month 25 Day
Last modified on	2013 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004436

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.