UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014465 |
|---|---|
| Receipt number | R000016347 |
| Scientific Title | Long-term efficacy of acetylcholinesterase inhibitors on cognitive function. -Comparison between drugs. |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2014/07/03 10:26:54 |
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Basic information
Public title
Long-term efficacy of acetylcholinesterase inhibitors on cognitive function. -Comparison between drugs.
Acronym
Long-term efficacy of acetylcholinesterase inhibitors on cognitive function.
Scientific Title
Long-term efficacy of acetylcholinesterase inhibitors on cognitive function. -Comparison between drugs.
Scientific Title:Acronym
Long-term efficacy of acetylcholinesterase inhibitors on cognitive function.
Region
| Japan |
Condition
Condition
Altzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Two oral acethycholinesterase inhibitors, donepezil and galantamine, are frequently prescribed for Alzheimer's disease patients. However, there is no long-term comparison study on cognitive function in Japan. In this study, we compare the long-term effect of these two drugs on cognitive function in a large number of Alzheimer's disease patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mini Mental State Examination (MMSE) score change form baseline at 12 months treatment.
Key secondary outcomes
Mini Mental State Examination (MMSE) score change form baseline at 6 months treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Galantamin is administered in a half of the patients agreed with this study. The starting dose of galantamin is 8 mg/day, and the maintenance dose is 16-24 mg/day.
The study period is 12 months. Blinded examiners evaluate cognitive function using MMSE at baseline, 6 months, and 12 months treatment.
Interventions/Control_2
Donepezil is adiministerd in a half of the patients agreed with this study. The starting dose of denepezil is 3 mg/day, and the maintenance dose is 5 mg/day.
The study period is 12 months. Blinded examiners evaluate cognitive function using MMSE at baseline, 6 months, and 12 months treatment.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Untreated Altzheimer's disease patients with MMSE score between 10 and 27 at screening.
Key exclusion criteria
The patients with allergy to cholinesterase inhibitors are excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kana Tojo |
Organization
Shinshu University of Medicine
Division name
Neurology and Rheumatology
Zip code
Address
3-1-1 Asahi, Matsumoto 390-8621, Japan
TEL
0263-37-2673
tkana@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kana Tojo |
Organization
Shinshu University of Medicine
Division name
Neurology and Rheumatology
Zip code
Address
3-1-1 Asahi, Matsumoto 390-8621, Japan
TEL
0263-37-2673
Homepage URL
tkana@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Neurology and Rheumatology, Shinshu University of Medicine
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
信州大学病院（長野県)/Shinshu University Hospital (Nagano Prefecture)
一之瀬脳神経外科病院（長野県)/Ichinose Neurosurgical Hospital (Nagano Prefecture)
伊那中央病院（長野県)/Ina Central Hospital (Nagano Preference)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 03 | Day |
Last modified on
| 2014 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016347
