PET scan for Parkinson's (NCT04101968)

Detect early Parkinson brain changes

Trial ID
NCT04101968
Official Title
Multimodal Molecular Imaging and Biometric Analysis in GBA-PD and Asymptomatic GBA-mutation Carriers
Goal
Detect early Parkinson brain changes
Status
RECRUITING
Sponsor
Pacific Parkinson's Research Centre
Study Type
OBSERVATIONAL
Enrollment
25 participants
Conditions
Parkinson Disease, GBA Gene Mutation, Gaucher Disease
Interventions
PET scan, neuroQWERTY

Summary For Families

Goal: to spot molecular and digital markers that distinguish people with Parkinson's who carry a GBA gene mutation from carriers who have no symptoms, to better understand early or GBA-specific brain changes. Approach: participants have PET scans to image molecular brain changes, for example dopamine system integrity or metabolic and inflammatory signals, and use neuroQWERTY, a keystroke and smartphone-based biometric tool that analyzes typing and movement patterns for subtle motor and cognitive signs; some PD participants may need brief medication withdrawal for the imaging, while the digital measures work without changing medications. Eligibility: adults 18 to 80 who are heterozygous for a pathogenic GBA mutation or polymorphism can join, while people with other neurological disorders, MRI-unsafe implants, severe claustrophobia, inability to tolerate stopping antiparkinsonian meds, or current cholinergic drug treatment are excluded.

Locations

  • Oregon Health & Science University, Portland, Oregon, United States
  • University of Washington, Seattle, Washington, United States
  • Pacific Parkinson's Research Centre | University of British Columbia, Vancouver, British Columbia, Canada

Frequently Asked Questions

What is this trial testing?
This trial is studying PET scan. Goal: to spot molecular and digital markers that distinguish people with Parkinson's who carry a GBA gene mutation from carriers who have no symptoms, to better understand early or GBA-specific brain changes. Approach: participants have PET scans to image molecular brain changes, for example dopamine system integrity or metabolic and inflammatory signals, and use neuroQWERTY, a keystroke and smartphone-based biometric tool that analyzes typing and movement patterns for subtle motor and cognitive signs; some PD participants may need brief medication withdrawal for the imaging, while the digital measures work without changing medications. Eligibility: adults 18 to 80 who are heterozygous for a pathogenic GBA mutation or polymorphism can join, while people with other neurological disorders, MRI-unsafe implants, severe claustrophobia, inability to tolerate stopping antiparkinsonian meds, or current cholinergic drug treatment are excluded.
Who can participate?
Participants must be between 18 Years and 80 Years.
Where is this trial located?
This trial is recruiting at 3 locations.
Does it cost anything to join?
You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
How long does the trial last?
This trial is estimated to last approximately 6 years and 8 months.
Can I leave the trial if I change my mind?
Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
Can my spouse or care partner come with me to visits?
In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
Will I get a placebo in this trial?
This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
What procedures are involved in this trial?
Based on the protocol, this trial involves: PET scan (minimally invasive); Blood draw (minimally invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov