UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008228 |
|---|---|
| Receipt number | R000009698 |
| Scientific Title | Development of method for early diagnosis of frontotemporal lober degeneration(FTLD), and search for clinical and genetic factors which influence a natural history |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2016/05/18 19:13:16 |
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Basic information
Public title
Development of method for early diagnosis of frontotemporal lober degeneration(FTLD), and search for clinical and genetic factors which influence a natural history
Acronym
a study of natural history of FTLD
Scientific Title
Development of method for early diagnosis of frontotemporal lober degeneration(FTLD), and search for clinical and genetic factors which influence a natural history
Scientific Title:Acronym
a study of natural history of FTLD
Region
| Japan |
Condition
Condition
FTLD
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
prospective study of natural history of FTLD by examining executive function, assessing activity of daily living(ADL) and using MRI
Basic objectives2
Others
Basic objectives -Others
search for clinical and genetic factors which influence a natural history
development of method to diagnose as FTLD by examining cerebrospinal fluid,using MRI and performing genetic test
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
natural history of Japanese patients with FTLD, especially on progression of executive dysfunction, deterioration of ADL and atrophy pattern on MRI
correlation between clinical diagnosis and histopathological diagnosis
Key secondary outcomes
natural history of patients with frontotemporal dementia(FTD), especially on progression of executive dysfunction, deterioration of ADL and atrophy pattern on MRI
clinical and genetic factors which influence a natural history
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It dpends on criteria for bvFTD(Katya Rascovsky et al. Brain 2011;134:2456-2477) and PPA(M.L. Gorno-Tempini et al. Neurology 2011;76:1006-1014).
Key exclusion criteria
We don't make especially exclusion criteria.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sobue Gen |
Organization
Nagoya University
Division name
Brain and Mind Research Center
Zip code
Address
5, Tsurumaicho, Syowa-ku, Nagoya-shi
TEL
052-741-2111
sobueg@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masuda Michihito |
Organization
Nagoya University
Division name
Department of Neurology
Zip code
Address
5, Tsurumaicho, Syowa-ku, Nagoya-shi
TEL
052-741-2111
Homepage URL
michihito.masuda@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
strategic research program for brain science
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
名古屋大学医学部付属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 01 | 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
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | 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
We will perform prospective study of cognitive function, ADL, and MRI on patients with FTD.
We will perform MMSE, ACE-R, FAB, and WAB to assess cognitive function.
We will use DAD to assess their ADL.
We will use CBI to assess their neuropsychiatric symptom.
We will use Zarit to assess caregiver's burden.
Management information
Registered date
| 2012 | Year | 06 | Month | 22 | Day |
Last modified on
| 2016 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009698
