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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 6 years and 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.