UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014834 |
|---|---|
| Receipt number | R000017238 |
| Scientific Title | The evaluation of FDDNP-PET in neurodegenerative diseases |
| Date of disclosure of the study information | 2014/08/12 |
| Last modified on | 2017/08/14 09:49:18 |
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Basic information
Public title
The evaluation of FDDNP-PET in neurodegenerative diseases
Acronym
Neuro-FDDNP study
Scientific Title
The evaluation of FDDNP-PET in neurodegenerative diseases
Scientific Title:Acronym
Neuro-FDDNP study
Region
| Japan |
Condition
Condition
dementia and Parkinsonism
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of FDDNP images in the diseases of demantia and Parkinsinism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the characteristics of FDDNP images in Alzheimer's disease, DLB, vascular dementia, frontotemporal dementia, NPH, Parkinson disease, PSP, CBD and MSA
Key secondary outcomes
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
Patients of demantia and Parkinsonism
Key exclusion criteria
alcohol allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kondo |
Organization
Kyoto prefectural university of medicine
Division name
Department of Neurology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566
TEL
075-251-5793
maskondo@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Kondo |
Organization
Kyoto prefectural university of medicine
Division name
Department of Neurology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566
TEL
075-251-5793
Homepage URL
maskondo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Neurology, Kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Kyoto prefectural university of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
FDDNP-PET was performed with 17 cases.
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
17 cases included 5 PSP, 4 Alzhemer's disease, 3 Parkinson disease, one DLB, 2 NPH cases.
Management information
Registered date
| 2014 | Year | 08 | Month | 11 | Day |
Last modified on
| 2017 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017238
