UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of simple support tool for the diagnosis of frontotemporal lobar degeneration by speech analysis using artificial intelligence
Title of the study (Brief title)	Development of simple support tool for the diagnosis of frontotemporal lobar degeneration
Region	Japan

Condition
Condition	FTLD ALS AD
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of simple support tool for the diagnosis of frontotemporal lobar degeneration by speech analysis using artificial intelligence
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity and specificity for diagnosis of FTLD
Key secondary outcomes

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	We will focus on cases clinically diagnosed as FTLD (bvFTD, SD, PNFA) and amyotrophic lateral sclerosis (ALS) For comparison with FTLD, we will focus on AD patients and healthy control subjects.
Key exclusion criteria	We exclude cases that do not meet the diagnostic criteria.
Target sample size	120

Research contact person
Name of lead principal investigator	Watanabe Hirohisa
Organization	Nagoya University
Division name	Brain and Mind Research Center
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-1975
Email	bmrc@adm.nagoya-u.ac.jp

Public contact
Name of contact person	Kato Toshiyasu
Organization	Nagoya University
Division name	Department of Neurology
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-741-2111
Homepage URL
Email	kato.toshiyasu@g.mbox.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Department of Neurology
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 11 Day
Anticipated trial start date	2018 Year 10 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	By recording and evaluating the sound of the patients with FTD and its related diseases, we will develop an evaluation tool that is useful for the early diagnosis of FTD.

Management information
Registered date	2018 Year 08 Month 15 Day
Last modified on	2018 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038402