NCT03146429

Brief Summary

This is the re-analyzing study of observational study by Parkinson's Progression Markers Initiative

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

May 7, 2017

Last Update Submit

April 22, 2018

Conditions

Weight Change, Body

Outcome Measures

Primary Outcomes (1)

  • Weight change

    weight change per year until 5 years after SPECT

    1, 2, 3, 4, 5 year after SPECT

Interventions

I-123 FP-CIT Single photon emission tomographyDIAGNOSTIC_TEST

Brain scan for dopamine transporter

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of 192 healthy controls with screening 123I-FP-CIT SPECT.

You may qualify if:

  • males or females with their age of 30 years or older at screening

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 10, 2017

Study Start

January 1, 2017

Primary Completion

April 15, 2017

Study Completion

April 15, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04