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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001256
Receipt No. R000001531
Scientific Title The changes of QOL in patients with Alzherimer's disease through medical treatment: an observational study
Date of disclosure of the study information 2008/07/19
Last modified on 2013/04/22

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Basic information
Public title The changes of QOL in patients with Alzherimer's disease through medical treatment: an observational study
Acronym The changes of QOL in AD
Scientific Title The changes of QOL in patients with Alzherimer's disease through medical treatment: an observational study
Scientific Title:Acronym The changes of QOL in AD
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the changes of QOL indices in Alzheimer's disase through medical treatment
Basic objectives2 Others
Basic objectives -Others To grasp the changes in QOL
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes in QOL
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. Alzheimer's disease according to DSM-IV
1-1. met criteria of Alzheimer's disease in DSM-IV
1-2. equal to and less than 6 point in The Ischemic score of Hachinski
2. 60 years old and more of age
3. outpatients or home visted patients
Key exclusion criteria 1. bed ridden patients
2. patients with severe impairment of visual acuity, auditory sensor and/or communication
3. neurological degenerative disease except for Alzheimer's disease, schizophrenia, bipolar disorder and major depression according to DSM-IV
4. patients with delirium due to abuse of alcohol, drugs, metabolic toxicity and inflammation
5.inadequate patients decided by medical doctors
Target sample size 100

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 1-14-1Ebara,Shinagawa-ku,Tokyo,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Non Profit Organization Institute of Community Medicine and Welfare for Central Nervous System
Division name management office
Zip code
Address
TEL
Homepage URL
Email

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
2008 Year 07 Month 19 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
2008 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine values of QOL indices of newly patients with Alzheimei's disease and their care givers at initial visits and at 3.5 months of post-treatment.

Management information
Registered date
2008 Year 07 Month 18 Day
Last modified on
2013 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001531

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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