UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009473 |
|---|---|
| Receipt number | R000011126 |
| Scientific Title | The efficacy and response of donepezil in severe Alzheimer disease: multi-modal neuroimaging analysis (structural and functional neuroimaging) of open-label, clinical trial |
| Date of disclosure of the study information | 2012/12/24 |
| Last modified on | 2014/12/03 11:33:45 |
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Basic information
Public title
The efficacy and response of
donepezil in severe
Alzheimer disease: multi-modal neuroimaging analysis
(structural and functional neuroimaging) of open-label, clinical trial
Acronym
Multi-modal neuroimaging analysis
of open-trial of donepezil in severe
Alzheimer disease
Scientific Title
The efficacy and response of
donepezil in severe
Alzheimer disease: multi-modal neuroimaging analysis
(structural and functional neuroimaging) of open-label, clinical trial
Scientific Title:Acronym
Multi-modal neuroimaging analysis
of open-trial of donepezil in severe
Alzheimer disease
Region
| Japan |
Condition
Condition
Alzheimer disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the treatment effect and response of donepezil in severe Alzheimer disease used by multi-modal neuroimaging analysis (structural and functional neuroimaging)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
multi-modal neuroimaging analysis
1 Structural neuroimaging analysis
Brain MRI:
voxel-based morphometry (VBM)
diffusion tensor imaging (DTI)
2 Functional neuroimaging analysis
single photon emission computed tomography (SPECT)
near-infrared spectroscopy (NIRS)
Key secondary outcomes
1 Cognitive assessment
Mini-Mental State Examination (MMSE)
Clock drawing test
The Alzheimer Disease Assessment Scale cognitive subscale (ADAS-cog)
Frontal assessment battery (FAB)
2 Behavior assessment
Clinical assessment for spontaneity (CAS)
Neuropsychiatry Inventory Questionnaire (NPI-Q)
Quality of life-Alzheimer Disease (QOL-AD) Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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 open-label, 12-month study evaluated the treatment effect and response of severe Alzheimer patients who had previously treated with donepezil 5mg day. The total daily dose was increased by 10 mg day and maintained.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A diagnosis of probable AD according to the National Institute of Neurological and Communication Disorders and Stroke Alzheimer Disease and Related Disorders Association criteria, severe stage, reliable informed consent could be obtained from the patient and or his her relatives, the chief caregiver is the patients family , over the half of a year during the treatment with donepezil 5mg day.
Key exclusion criteria
either previous history or now taking other choline inhibitors (galantamine, rivastigmine) and memantine, taking antipsychotic or antidepressant medication
,there was a previous history of mental illness or substance abuse, either an MRI or a CT scan had revealed focal brain lesions,routine blood tests (including evaluation of serum vitamin B12 and thyroid function) were abnormal findings, the patient has pacemaker, other findings in terms with the aims of this study
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shutaro Nakaaki |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry, Laboratory of Aging, Behavior and Cognition
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-3353-1211
hzi05510@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shutaro Nakaaki |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry, Laboratory of Aging, Behavior and Cognition
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-3353-1211
Homepage URL
hzi05510@nifty.com
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School 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
none
Name of secondary funder(s)
none
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
慶應義塾大学病院（東京都） Keio University School of Medicine (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 24 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 03 | Day |
Last modified on
| 2014 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011126
