UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030527 |
|---|---|
| Receipt number | R000034848 |
| Scientific Title | The efficacy of droxidopa fot the patients with MAPT mutation and PSP evaluated by tau imaging. |
| Date of disclosure of the study information | 2018/01/04 |
| Last modified on | 2022/01/13 17:52:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of droxidopa fot the patients with MAPT mutation and PSP evaluated by tau imaging.
Acronym
The efficacy of droxidopa fot the patients with MAPT mutation and PSP evaluated by tau imaging.
Scientific Title
The efficacy of droxidopa fot the patients with MAPT mutation and PSP evaluated by tau imaging.
Scientific Title:Acronym
The efficacy of droxidopa fot the patients with MAPT mutation and PSP evaluated by tau imaging.
Region
| Japan |
Condition
Condition
The patients with frontotemporal dementia harboring MAPT N279K and progressive supranuclear palsy-Richardson type.
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluate the tau burden for the patients with frontotemporal dementia with MAPT N279K and progressive supra nuclear palsy, at the time before and after treatments of droxidopa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PBB3-PET, basic examinations of blood, urine, and cerebrospinal fluids. Metabolome, cognitive test, brain MRI, and SPECT.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with MAPT N279K mutation and progressive supranuclear palsy.
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
| 12 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients has bee known to have MAPT N279K, and defined clinical diagnosis as progressive supuranuclear palsy.
Key exclusion criteria
Exclude the patients not defined the above criteria.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobutaka |
| Middle name | |
| Last name | Hattori |
Organization
Juntendo University School of Medicine
Division name
Neurology
Zip code
113-0033
Address
Bunkyo-ku
TEL
0338133111
nishioka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Nishioka |
Organization
Juntendo University School of Medicine
Division name
Neurology
Zip code
1130033
Address
Bunkyo-ku
TEL
0338133111
Homepage URL
nishioka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Brain Disorder Translational Research Team, Department of Functional Brain Imaging Research (DOFI), Clinical Research Cluster, National Institute of Radiological Sciences (NIRS), National Institutes for Quantum and Radiological Science and Technology (QS
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University School of Medicine
Address
2-1-1 Hongo Bunkyo-ku, Tokyo
Tel
03-3813-3111
nishioka@juntendo.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
| 2018 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
15
Results
We examined tau-imaging for 14 patients with sporadic PSP and one patient with MAPT N279K. The results partially showed the spreading and increased accumulation of tau protein. Our sequential examinations confirmed the increased tau protein in vivo.
Results date posted
| 2022 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
14 patients with sporadic PSP and one patient with MAPT N279K.
Participant flow
We enrolled the patients at Juntendo University. The patients were examined by tau-imaging at National Institute of Radiological Sciences.
Adverse events
none
Outcome measures
Quantitative analyses of tau imaging.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034848
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
