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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010559
Receipt No. R000012343
Scientific Title A study on the assessment of symptoms of dementia
Date of disclosure of the study information 2013/05/01
Last modified on 2015/04/28

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Basic information
Public title A study on the assessment of symptoms of dementia
Acronym The assessment of symptoms of dementia
Scientific Title A study on the assessment of symptoms of dementia
Scientific Title:Acronym The assessment of symptoms of dementia
Region
Japan

Condition
Condition DAT and DLB
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop the assessment tools for diverse symptoms of dementia
Basic objectives2 Others
Basic objectives -Others To grasp the changes in symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes in scales of assessment of the symptoms
Key secondary outcomes

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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. DAT
1-1. met criteria of Alzheimer's disease in DSM-4
1-2. not met criteria of dementia with Lewy bodies in 3rd CDLB
1-3. equal to and less than 6 point in the Ischemic score of Hachinski
2. DLB
2-1. met criteria of possible or probable dementia with Lewy bodies in 3rd CDLB
3. 60 yearas old and more of age
4. outpatients of home visited patients
Key exclusion criteria 1. bed ridden persons
2. persons with severe impariment of visual acuity, auditory sensor and/or communication
3. neurological degenerative disease except for DTA or DLB criteria, schizophrenia, bipolar disorder and major depression according to DSM-4
4. persons with delirium due to abuse of alcohol, drugs, metabolic toxicity and inflammation
5. under 0.3 corrected visual acuity of both eyes
6. cataract surgery of both eyes
7. inadequate persons decided by medical doctors
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Kinoshita
Organization Kodama clinic
Division name hospital director
Zip code
Address 1-14-1 Ebara, Shinagawa-ku, Tokyo, Japan
TEL 03-5759-6766
Email kato@ebms.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Suganuma
Organization Non Profit Organization Institute of Community Medicine and Welfare for Central Nervous System
Division name management office
Zip code
Address 3-1-5 komagome,Toshima-ku, Tokyo
TEL 03-5777-1010
Homepage URL
Email kato@ebms.co.jp

Sponsor
Institute Non Profit Organization Institute of Community Medicine and Welfare for Central Nervous System
Institute
Department

Funding Source
Organization Non Profit Organization Institute of Community Medicine and Welfare for Central Nervous System
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 01 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 Completed
Date of protocol fixation
2012 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 10 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 To compare scales of symptoms of dementia between groups, and examine at initial visits and at 3.5 months of post-treatment

Management information
Registered date
2013 Year 04 Month 22 Day
Last modified on
2015 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012343

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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