UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of method for early diagnosis of frontotemporal lober degeneration(FTLD), and search for clinical and genetic factors which influence a natural history
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Sobue Gen
Organization	Nagoya University
Division name	Brain and Mind Research Center
Address	5, Tsurumaicho, Syowa-ku, Nagoya-shi
TEL	052-741-2111
Email	sobueg@med.nagoya-u.ac.jp

Public contact
Name of contact person	Masuda Michihito
Organization	Nagoya University
Division name	Department of Neurology
Address	5, Tsurumaicho, Syowa-ku, Nagoya-shi
TEL	052-741-2111
Homepage URL
Email	michihito.masuda@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine Department of Neurology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2012 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009698