UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009934 |
|---|---|
| Receipt number | R000011639 |
| Scientific Title | Effectiveness of Galantamine on the care burden of family caregivers of patients with Alzheimer's disease |
| Date of disclosure of the study information | 2013/02/05 |
| Last modified on | 2015/09/28 19:51:52 |
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Basic information
Public title
Effectiveness of Galantamine on the care burden of family caregivers of patients with Alzheimer's disease
Acronym
Effectiveness of Galantamine on the care burden in Alzheimer's disease
Scientific Title
Effectiveness of Galantamine on the care burden of family caregivers of patients with Alzheimer's disease
Scientific Title:Acronym
Effectiveness of Galantamine on the care burden in Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether Galantamine relieves the care burden in Alzheimer's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Zarit Burden Interview
Key secondary outcomes
Neuropsychiatric Inventory
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Galantamine treatment
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The subjects met the criteria of Alzheimer's disease in the Nationnal Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders association
(NINCDS-ADRDA)
2. The subjects score more than 15 and less than 27 in the MMSE.
3. outpatients
Key exclusion criteria
1. Alcoholics
2. patients with epilepsy
3.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko Motoi |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
Bunkyo-ku Hongo 2-1-1, Tokyo
TEL
03-3813-3111
motoi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Motoi |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
Bunkyo-ku Hongo 2-1-1, Tokyo
TEL
03-3813-3111
Homepage URL
motoi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 02 | Month | 05 | 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
Galantemine administration improved the score of apathy in NPI scale, however, it failed to improve the Zarit caregiver burden interview.
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
| 2013 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 02 | Day |
Last modified on
| 2015 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011639
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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