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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018468
Receipt No. R000020233
Official scientific title of the study Japanese Longitudinal Biomarker Study in PSP and CBD
Date of disclosure of the study information 2015/08/01
Last modified on 2017/07/30

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Basic information
Official scientific title of the study Japanese Longitudinal Biomarker Study in PSP and CBD
Title of the study (Brief title) Japanese Longitudinal Biomarker Study in PSP and CBD (JALPAC)
Region
Japan

Condition
Condition progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), corticobasal syndrome (CBS)
Classification by specialty
Neurology Geriatrics Psychiatry
Laboratory medicine Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The present project is a longitudinal observation study. The aims of the study are as follows. 1) To clarify natural history of patients with PSP/CBD syndrome, 2) To explore diagnostic and prognostic biomarker
Basic objectives2 Others
Basic objectives -Others Validation of published diagnostic criteria for Japanese patients with PSP/CBS
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes - Elucidation of the natural history
- Development of new biomarker(s)
Key secondary outcomes - Clinical evaluations including cognitive, language, oculomotor, and motor functions during the observation period.
- Clinical severity
- MRI (volumetric analysis)
- Known CSF and blood biomarkers
- Neuropathological examination

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 1) Patients 20 years of age or older who provide written informed consent

2) Healthy volunteers 20 years of age or older who provide written informed consent

3) Patients meeting the NINDS-SPSP diagnostic criteria (Litvan 1996)

4) Patients meeting the modified version of the Cambridge CBS diagnostic criteria (Mathew 2012)

5) Patients meeting the CBD diagnostic criteria (Armstrong 2013)

6) Patients who do not meet the diagnostic criteria of PSP/CBS, but clinically suspected as having these conditions
Key exclusion criteria fulfill the diagnostic criteria of other neurodegenerative disorders
Target sample size 150

Research contact person
Name of lead principal investigator Takeshi Ikeuchi
Organization Niigata University, Brain Research Institute
Division name Center for Bioresource
Address 1-757 Asahimachi, Niigata 951-8585, Japan
TEL 025-227-2343
Email ikeuchi@bri.niigata-u.ac.jp

Public contact
Name of contact person Takeshi Ikeuchi
Organization Niigata University, Brain Research Institute
Division name Molecular Genetics
Address 1-757 Asahimachi, Niigata 951-8585, Japan
TEL 025-227-2343
Homepage URL
Email ikeuchi@bri.niigata-u.ac.jp

Sponsor
Institute Tottori University Faculty of Medicine, Department of Neurology
Niigata University, Brain Research Institute, Department of Molecular Genetics
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 Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Research Committee of CNS Degenerative Diseases
Name of secondary funder(s) MHLW (Japan)

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 鳥取大学病院(鳥取県)/ Tottori University (Tottori),新潟大学医歯学総合病院(新潟県)/ Niigata University (Niigata),神戸大学病院(兵庫県)/ Kobe University (Hyogo),名古屋大学病院(愛知県)/ Nagoya University (Aichi),東京都立神経病院(東京都)/ Tokyo Metropolitan Neurological Hospital (Tokyo),自治医科大学病院(栃木県)/ Jichi Medical University (Tochigi),高知大学(高知県)/ Kochi University (Kochi),松江医療センター(島根県)/ Matsue Medical Center (Shimane),東名古屋病院(愛知県)/ East Nagoya National Hospital (Aichi),倉敷平成病院(岡山県)/ Kurashiki-Heisei Hospital (Okayama),三朝温泉病院(鳥取県)/ Misasa-Onsen Hospital (Tottori),群馬大学病院(群馬県)/ Gunma University (Gunma),京都府立医科大学病院(京都府)/ Kyoto Prefectural University of Medicine,東京都健康長寿医療センター病院(東京都)/ Tokyo Metropolitan Geriatric Hospital (Tokyo),相模原病院(神奈川県)/ Sagamihara National Hospital (Kanagawa),千葉東病院(千葉県)/ Chiba East National Hospital (Chiba),岡山旭東病院(岡山県)/ Okayama Kyokuto Hospital (Okayama),山梨大学(山梨県)/ Yamanashi University (Yamanashi),国立精神・神経研究センター(東京都)/ National Center Hospital NCNP (Tokyo),順天堂大学病院(東京都)/ Juntendo University (Tokyo),愛知医科大学病院(愛知県)/ Aichi Medical University (Aichi),徳島大学(徳島県)/ Tokushima University (Tokushima),ビハーラ花の里病院(広島県)/ Vihara Hananosato Hospital (Hiroshima),東京大学病院(東京都)/ University of Tokyo (Tokyo),老年病研究所病院(群馬県)/ Geriatric Disease Research Hospital (Gunma),三重大学病院(三重県)/ Mie University (Mie),千葉大学病院(千葉県)/ Chiba University (Chiba),順天堂大学越谷病院(埼玉県)/ Juntendo University Koshigaya Hospital (Saitama),東北大学病院(宮城県)/ Tohoku University (Miyagi),岡山大学病院(岡山県)/ Okayama University (Okayama),福岡大学病院(福岡県)/ Fukuoka University (Fukuoka),大阪大学病院(大阪府)/ Osaka University (Osaka),北海道大学病院(北海道)/ Hokkaido University,産業医科大学病院(福岡県)/ University of Occupational and Environmental Health (Fukuoka) / 東京医科歯科大学病院(東京)/ Tokyo Medical and Dental University,国立病院機構 兵庫中央病院 / Hyogo Central Hospital,東邦大学医療センター大森病院 / Toho University Medical Center Ohmori Hospital,国立病院機構 三重病院 / Mie Hospital,富士見高原病院 / Fujimi-Kogen Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 11 Month 01 Day
Anticipated trial start date
2014 Year 11 Month 17 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 This study is a multicenter observational study in which case and control subjects will be recruited and longitudinally followed.

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2017 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020233


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