UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018035 |
|---|---|
| Receipt number | R000020861 |
| Scientific Title | Evaluation of Amyloid Imaging in Patients with Parkinson's disease |
| Date of disclosure of the study information | 2015/06/23 |
| Last modified on | 2017/06/24 14:48:33 |
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Basic information
Public title
Evaluation of Amyloid Imaging in Patients with Parkinson's disease
Acronym
Evaluation of Amyloid Imaging in Parkinson's disease
Scientific Title
Evaluation of Amyloid Imaging in Patients with Parkinson's disease
Scientific Title:Acronym
Evaluation of Amyloid Imaging in Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to determine whether the amyloid burden, as indexed by 18F-florbetaben, identifies PD and whether amyloid burden affects cognitive decline and predicts clinical feature in subjects with PD.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Parkinson disease who have abnormal metabolism on positive amyloid PET (stage 2 preclinical AD) and those who have abnormal metabolism on an FDG-PET scan and normal amyloid PET (which may represent non-preclinical AD but suggest other neurological disease) will be monitored for a long term to assess changes in clinical features and cognitive function over time.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study population consists of patients with PD, who are recruited in Keio Parkinson's Disease Database. All patients must be more than MMSE 26.
Key exclusion criteria
disaggrement
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Ito |
Organization
Keio University School of Medicine
Division name
Department of Neurology,
Zip code
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
03-5363-3788
d-ito@jk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Ito |
Organization
Keio University School of Medicine
Division name
Department of Neurology,
Zip code
Address
35 Shinanomachi, Shinjuku-ku,Tokyo 160-8582, Japan
TEL
03-5363-3788
Homepage URL
d-ito@jk9.so-net.ne.jp
Sponsor or person
Institute
Department of Neurology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Piramal
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 06 | Month | 23 | 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
We report that PD without dementia shows an extremely low prevalence of beta Amyloid positivity compared to findings in cognitively normal elderly controls. Further longitudinal imaging studies and long-term follow-up of cognitive function are needed; however, our findings provide novel insights for a deeper understanding of beta Amyloid metabolism and deposition in PD.
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
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 01 | Day |
Other
Other related information
The subjects will undergo the following assessments:
Amyloid PET (18F-florbetaben)
Cognitive function tests (MMSE, CDR and MoCA-J)
Assessments of symptoms and insight (UPDRS, NPI and GDS)
Management information
Registered date
| 2015 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020861
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
