UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014319 |
|---|---|
| Receipt number | R000016671 |
| Scientific Title | The effect of the transdermal acetylcholine esterase inhibitors on frontal lobe function in Alzhemer's disease patients |
| Date of disclosure of the study information | 2014/06/19 |
| Last modified on | 2015/05/27 10:45:37 |
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Basic information
Public title
The effect of the transdermal acetylcholine esterase inhibitors on frontal lobe function in Alzhemer's disease patients
Acronym
The effect of the transdermal acetylcholine esterase inhibitors on frontal lobe function
Scientific Title
The effect of the transdermal acetylcholine esterase inhibitors on frontal lobe function in Alzhemer's disease patients
Scientific Title:Acronym
The effect of the transdermal acetylcholine esterase inhibitors on frontal lobe function
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will demonstrate the effectiveness of the transdermal acetylcoline esterase inhibitors on the impainment of frontal lobe function in Alzheimer's disease paitients neuropsychological test
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CPT test and memory updating test (part of CAT)
Key secondary outcomes
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
The transdermal acetylcholine esteras inhibitors
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed mild to moderate Alzheimer's disease(MMSE10-23 and CDR 0.5-2)
Naive patients for AD treatments patients swithching from donepezil/galatamine(requiring wash out for 4weeks),if necessary.
Male and female AD patients basically outpatients,how ever inpatients can be included if necessary
Key exclusion criteria
Severa AD patients(MMSE<10)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Mimura |
Organization
Keio University
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi shinjyuku-ku Tokyo 160-8582 Japan
TEL
0353633829
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime tabuchi |
Organization
Keio University
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi shinjyuku-ku Tokyo 160-8582 Japan
TEL
0353633829
Homepage URL
tabuchi@a8.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Novartis fharma,INC.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Salvation Army Booth Mental Hospital
Tsutsuji-Mental Hospital
Ashikari clinic
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
| 2014 | Year | 06 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
Management information
Registered date
| 2014 | Year | 06 | Month | 19 | Day |
Last modified on
| 2015 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016671
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