UMIN-CTR Clinical Trial

Basic information
Public title	Japanese Longitudinal Biomarker Study in PSP and CBD
Acronym	Japanese Longitudinal Biomarker Study in PSP and CBD (JALPAC)
Scientific Title	Japanese Longitudinal Biomarker Study in PSP and CBD
Scientific Title:Acronym	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

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	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	1st name Middle name Last name Takeshi Ikeuchi
Organization	Niigata University, Brain Research Institute
Division name	Center for Bioresource
Zip code
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	1st name Middle name Last name Takeshi Ikeuchi
Organization	Niigata University, Brain Research Institute
Division name	Molecular Genetics
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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	Open public recruiting
Date of protocol fixation	2014 Year 11 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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