- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03146429
Prediction of Future Weight Change With Dopamine Transporter
April 22, 2018 updated by: Kyoungjune Pak, Pusan National University Hospital
This is the re-analyzing study of observational study by Parkinson's Progression Markers Initiative
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population consisted of 192 healthy controls with screening 123I-FP-CIT SPECT.
Description
Inclusion Criteria:
- males or females with their age of 30 years or older at screening
Exclusion Criteria:
- subjects with a neurological disorder, a first degree relative with idiopathic PD, Montreal Cognitive Assessment score of 26 or less, medications that might interfere with DAT SPECT scans, anticoagulants that might preclude safe completion of the lumbar puncture, or investigational drugs, and a condition that precludes the safe performance of routine lumbar puncture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight change
Time Frame: 1, 2, 3, 4, 5 year after SPECT
|
weight change per year until 5 years after SPECT
|
1, 2, 3, 4, 5 year after SPECT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Actual)
April 15, 2017
Study Completion (Actual)
April 15, 2017
Study Registration Dates
First Submitted
May 7, 2017
First Submitted That Met QC Criteria
May 7, 2017
First Posted (Actual)
May 10, 2017
Study Record Updates
Last Update Posted (Actual)
April 24, 2018
Last Update Submitted That Met QC Criteria
April 22, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PusanNUH-2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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