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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009473
Receipt No. 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

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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
Email 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
Email hzi05510@nifty.com

Sponsor
Institute Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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