UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048965
Receipt number R000055787
Scientific Title Clinical characteristics of Frontotemporal lobar degeneration with tau pathology
Date of disclosure of the study information 2022/09/20
Last modified on 2024/03/22 14:29:00

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Basic information

Public title

Clinical characteristics of Frontotemporal lobar degeneration with tau pathology

Acronym

Clinical characteristics of Frontotemporal lobar degeneration with tau pathology

Scientific Title

Clinical characteristics of Frontotemporal lobar degeneration with tau pathology

Scientific Title:Acronym

Clinical characteristics of Frontotemporal lobar degeneration with tau pathology

Region

Japan


Condition

Condition

Frontotemporal lobar degeneration

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

FTLD patients will be classified into tau-positive and tau-negative groups based on tau PET imaging findings. This study aims to characterize the clinical features and the neuroimaging biomarkers specific to the tau-positive group.

Basic objectives2

Others

Basic objectives -Others

Exploratory research

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical characteristics

Key secondary outcomes

Mini-Mental State Examination (MMSE), Frontal Assessment Battery (FAB), Addenbrooke's Cognitive Examination (ACE-R), Western Aphasia Battery (WAB), Neuropsychiatric Inventory (NPI), Stereotypy Rating Inventory (SRI), Cambridge Behavioral Inventory (CBI), Everyday Memory Checklist (EMC), Geriatric depression scale (GDS), the Lawton Instrumental Activities of Daily Living Scale (IADL), Physical Self-Maintenance Scale (PSMS), Clinical Dementia Rating (CDR), cranial MRI, brain SPECT


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

tau-positive group

Interventions/Control_2

tau-negative group

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

35 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Those who have at least one symptom of Possible bvFTD in the international diagnostic criteria for bvFTD (Rascovsky K et al, 2011) or at least one verbal symptom in Neary's diagnostic criteria for SD/PNFA (Neary D et al, 1998) and are suspected to have FTLD.
Those whose age is 35 years old or older and less than 90 years old at the time of consent.
Those who have given written consent to participate.

Key exclusion criteria

Women who are during pregnancy or breastfeeding.
Those who have cerebrovascular disorders that may affect the results of tau PET.
Those who are judged to be inappropriate for participation in this clinical study.

Target sample size

125


Research contact person

Name of lead principal investigator

1st name Manabu
Middle name
Last name Ikeda

Organization

Osaka University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code

565-0871

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

0668793051

Email

mikeda@psy.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Shunsuke
Middle name
Last name Sato

Organization

Osaka University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code

565-0871

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

0668793051

Homepage URL


Email

sato@psy.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University Clinical Research Review Committee

Address

2-2, Yamadaoka, Suita, osaka, japan

Tel

0662108296

Email

rinri@hp-crc.med.osaka-u.ac.jp


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

2022 Year 09 Month 20 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

Enrolling by invitation

Date of protocol fixation

2022 Year 09 Month 20 Day

Date of IRB

2022 Year 11 Month 07 Day

Anticipated trial start date

2022 Year 11 Month 07 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 09 Month 19 Day

Last modified on

2024 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055787


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name