UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001256
Receipt number 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 11:06:11

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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 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


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

Value
https://center6.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