UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003239 |
|---|---|
| Receipt number | R000003919 |
| Scientific Title | Influence of donepezil to behavioral and psychological symptoms of frontotemporal dementia |
| Date of disclosure of the study information | 2010/02/23 |
| Last modified on | 2010/02/23 15:49:11 |
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Basic information
Public title
Influence of donepezil to behavioral and psychological symptoms of frontotemporal dementia
Acronym
Donepezil in frontotemporal dementia
Scientific Title
Influence of donepezil to behavioral and psychological symptoms of frontotemporal dementia
Scientific Title:Acronym
Donepezil in frontotemporal dementia
Region
| Japan |
Condition
Condition
Frontotemporal dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study was to investigate the risk of donepezil in patients with frontotemporal dementia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuropsychiatric Inventory
Key secondary outcomes
Zarit Burden Interview
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
Discontinuation of donepezil
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Mini-Mental State Examination(MMSE)score ranges between 5 and 26.
2.Age ranges between 50 and 90 years old.
3.Outpatients
4.Subjects are misdiagnosed AD at other clinics, prescribed denepezil, and then diagnosed FTD at our outpatient clinic. FTD is diagnosed according to the clinical diagnostic criteria for FTD in frontotemporal lobar degeneration (Neary D et al. Neurology 1998; 51: 1546-1554).
5.Findings of cranial MRI or CT examined within 1 year before entory agree with diagnosis of FTD.
6.Written informed consent is obtained from subjects or their relatives before entry.
Key exclusion criteria
1.delirium due to metabolic intoxication and drug use
2.alcoholism, stroke, depression, manic state, and schizophrenia before the onset of FTD
3.previous use of tranquilizers and antidepressants
4.neoplastic disease and acute inflammation.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takemi Kimura |
Organization
National Hospital Organization Kikuchi Hospital
Division name
Division of Clinical Research
Zip code
Address
208 Fukuhara, Koshi, Kumamoto
TEL
+81-96-248-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takemi Kimura |
Organization
National Hospital Organization Kikuchi Hospital
Division name
Division of Clinical Research
Zip code
Address
TEL
Homepage URL
tkimura@kikuti.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kikuchi Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kikuchi Hospital
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 02 | Month | 23 | 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
| 2007 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | 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
| 2010 | Year | 02 | Month | 23 | Day |
Last modified on
| 2010 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003919
