UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010408 |
|---|---|
| Receipt number | R000012178 |
| Scientific Title | Efficacy of donepezil in Alzheimer's disease combined with cerebrovascular disease |
| Date of disclosure of the study information | 2013/04/07 |
| Last modified on | 2016/10/05 11:31:40 |
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Basic information
Public title
Efficacy of donepezil in Alzheimer's disease combined with cerebrovascular disease
Acronym
Donepezil in Alzheimer's disease combined with cerebrovascular disease
Scientific Title
Efficacy of donepezil in Alzheimer's disease combined with cerebrovascular disease
Scientific Title:Acronym
Donepezil in Alzheimer's disease combined with cerebrovascular disease
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of donepezile in patients with a diagnosis of Alzheimer's disease combined with cerebrovascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MMSE-J
Key secondary outcomes
CDR
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alzheimer disease
Interventions/Control_2
Alzheimer disease ombined with cerebrovascular disease
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Alzheimer disease or Alzheimer disease ombined with cerebrovascular disease
Key exclusion criteria
other dementia
Target sample size
460
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Suzuki |
Organization
Keio University,
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
0353633788
nrsuzuki@a2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Ito |
Organization
Keio University,
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
0353633788
Homepage URL
d-ito@jk9.so-net.ne.jp
Sponsor or person
Institute
Department of Neurology, Keio University,
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Keio University,
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 07 | 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
The entry of the study cooperator was difficult within research period.
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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | 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
| 2013 | Year | 04 | Month | 03 | Day |
Last modified on
| 2016 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012178
