Genotypic Influences on Network Progression in Parkinson's Disease (NCT04228172) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Genotypic Influences on Network Progression in Parkinson's Disease
United States32 participantsStarted 2020-02-24
Plain-language summary
In this longitudinal study, the investigators will follow Parkinson's disease (PD) patients with and without glucocerebrosidase (GBA) mutations. The investigators hypothesize that the rate of increase in brain network activity over time (network progression rate) is faster in patients with GBA gene mutations.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of PD made according to United Kingdom (UK) Parkinson's Disease Society Brain Bank Criteria
* Ability to provide written informed consent
* Age 40-75
* Stable dose of antiparkinsonian medication for \>1 month prior to study entry
Exclusion Criteria:
* Subjects with pathogenic mutations in LRRK2 related PD mutations (subjects with variants of uncertain significance (VUS) are eligible
* History of known causative factors such as encephalitis or neuroleptic treatment
* Patients with dementia (defined as Mini-Mental Status Exam score \<24 or a Telephone Interview for Cognitive Status score \<26)
* Atypical parkinsonian features including oculomotor abnormalities, incontinence, ataxia, sensory loss, or pyramidal signs
* Known structural brain lesions
* Patients with history of stroke, head injury, high intracranial pressure or severe headaches
* Psychiatric disorder, including a history of major depression in the past 36 months
* Pregnant or breastfeeding women (female subjects of child-bearing potential will be screened for pregnancy before imaging).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Increase in PD related metabolic pattern expression
Timeframe: Baseline and 18 months later
2
Increase in PD related functional pattern expression