UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010559 |
|---|---|
| Receipt number | 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 16:23:11 |
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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
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
kato@ebms.co.jp
Sponsor or person
Institute
Non Profit Organization Institute of Community Medicine and Welfare for Central Nervous System
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012343
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
