UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049438 |
|---|---|
| Receipt number | R000055427 |
| Scientific Title | Study on neurodegenerative disorders associated with mechanical and physical burdens such as chronic traumatic encephalopathy and idiopathic normal pressure hydrocephalus |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/05/09 18:10:02 |
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Basic information
Public title
Study on neurodegenerative disorders associated with mechanical and physical burdens such as chronic traumatic encephalopathy and idiopathic normal pressure hydrocephalus
Acronym
Study on chronic traumatic encephalopathy and idiopathic normal pressure hydrocephalus
Scientific Title
Study on neurodegenerative disorders associated with mechanical and physical burdens such as chronic traumatic encephalopathy and idiopathic normal pressure hydrocephalus
Scientific Title:Acronym
Study on chronic traumatic encephalopathy and idiopathic normal pressure hydrocephalus
Region
| Japan |
Condition
Condition
CTE
iNPH
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the pathophysiological mechanism of iNPH and CTE by using PET examinations.
Basic objectives2
Others
Basic objectives -Others
To examine the differences of PET accumulations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SUV ratio (SUVR)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
4
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
To conduct PET examinations using the following tracers: 18F-SMBT-1
Interventions/Control_2
To conduct PET examinations using the following tracers: 11C-PiB
Interventions/Control_3
To conduct PET examinations using the following tracers: 18F-flutemetamol
Interventions/Control_4
To conduct PET examinations using the following tracers: 18F-FDG
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CTE group with positive symptoms:
(1) Informed consent by the participant or by the substitues (native Japanese)
(2) Ages: basically 30 to 65 years old
(3) Fulfilling the conditions of CTE (history of playing contact sports for more than 10 years or traffic accidents etc.) with clear symptoms of CTE
(4) Those who can tolerate PET examination of up to 45 mins
Possible mild CTE group without positive symptoms:
(1) Informed consent by the participant or by the substitues (native Japanese)
(2) Ages: basically 30 to 65 years old
(3) Fulfilling the conditions of possible CTE (history of playing contact sports for more than 5 years or traffic accidents etc.) without clear symptoms of CTE
(4) Those who can tolerate PET examination of up to 45 mins
iNPH group with positive symptoms:
(1) Informed consent by the participant or by the substitues (native Japanese)
(2) Ages: basically 60 to 90 years old
(3) Fulfilling the conditions of iNPH and planning shunt operation
(4) Those who can tolerate PET examination of up to 45 mins
Healthy control (HC) group
(1) Informed consent by the participant or by the substitue (native Japanese)
(2) Ages: basically 30 to 90 years old
(3) Those who can tolerate relatively long PET examination (up to 2 hours)
Key exclusion criteria
(1) Administration of irreversible MAO-B inhibitors, Habitual smoking (within 1 year of entry)
(2) Being in the period of pregnancy, possible pregnancy, breast feeding, within 28 days after child birth
(3) Severe allergic reactions to drugs and foods
(4) Psychiatric disorders, which may make the participation to this study difficult
(5) Taboo conditions for MRI examinations (cardiac pacemaker, intracorpoporial metals, etc. to be checked with questionnaire in advance)
(6) Systemic circulatory and metabolic disorders as well as organ dysfuctions, such as diabetes melitus, hypertension, endocrinolog ical disorders, congestive heart failure, angina petoris, severe renal dysfunctions with Ccr<30mL/min or under plasmapheresis)
(7) Past history of malignant diseases within 1 year of entry
(8) Any sociomedial conditions, which may make the participation to this study difficult
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Tashiro |
Organization
Cyclotron and Radioisotope Center, Tohoku University
Division name
Division of Cyclotron Nuclear Medicine
Zip code
980-8578
Address
6-3 AzaAoba, Aramaki, Aoba-ku, Sendai
TEL
+81227957797
mtashiro@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Hiraoka |
Organization
Cyclotron and Radioisotope Center, Tohoku University
Division name
Division of Cyclotron Nuclear Medicine
Zip code
980-8578
Address
6-3 AzaAoba, Aramaki, Aoba-ku, Sendai
TEL
+81227957802
Homepage URL
khiraoka@cyric.tohoku.ac.jp
Sponsor or person
Institute
Cyclotron and Radioisotope Center, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
Seiryo-machi 1-1, Aramaki, Aoba-ku, Sendai
Tel
022-717-8654
ec@rinri.hosp.tohoku.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 | 12 | 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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055427
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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