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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018035
Receipt No. 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

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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
Email 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
Email d-ito@jk9.so-net.ne.jp

Sponsor
Institute Department of Neurology, Keio University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.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
Registered date File name


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