PET Scanning in Parkinson s Disease (NCT00024622) | Clinical Trial Compass
CompletedNot Applicable
PET Scanning in Parkinson s Disease
United States502 participantsStarted 2002-03-15
Plain-language summary
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-\[F-18\] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.
Who can participate
Age range
18 Years – 90 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:
* Age between 18 and 90 years
* Ability to give informed consent
* Ability to read and write
* Ability to give adequate medical and neuropsychiatric history.
PARKINSONS DISEASE:
* Individuals over the age of 18 from families in which an autosomal dominant form of Parkinson's disease is suspected based on pedigree analysis.
* Each subject will have a medical history and brief neurological examination.
* The diagnosis in probands must be supported by accepted clinical criteria: tremor, bradykinesia, and responsiveness to L-DOPA.
* Equivocally affected individuals will also be included in order to aid in their phenotypic classification as will at risk individuals who show no neurological signs.
* Individuals with sporadic Parkinson's disease will also be scanned. These will be over the age of 50 years and will have no known family history of Parkinson's disease or any other movement disorder.
* PD patients will have an admission physical exam and medical history as well as laboratory tests deemed necessary on the basis of history and physical exam.
SCHIZOPHRENIA:
\- Members of this patient group will have a diagnosis of schizophrenia or schizophrenia spectrum disorder as determined by the SCID and will be currently enrolled in NIH approved protocol 89-M-0160 (Inpatient Evaluation of Neuropsychiatric Patients) under which they will have received admission work-up.
HEALTHY VOLUNTEERS:
* A large cohort of healthy volunteers will also have a PET scan.
* V…
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.
1This trial used PET scanning to study how dopamine dysregulation affects the brain in both Parkinson's disease and schizophrenia — could you explain what that means for understanding my specific diagnosis, and whether the findings from this completed study are relevant to my care?
2Since this trial is already completed and wasn't testing a treatment but rather using PET imaging to explore brain changes, are there published results from this research that you think are worth reviewing together to better understand what's happening in my brain?
3This study looked at dopaminergic pathways in both Parkinson's disease and schizophrenia — given that those are quite different conditions, could you help me understand why they were studied together and what that might tell us about my situation?
4Because this was an observational imaging study rather than a treatment trial, are there follow-up studies or current trials that grew out of this kind of PET research that might actually be open for me to consider enrolling in?
5Would a PET scan of the type used in this study be something that could be useful in my own diagnosis or monitoring, and is that something we could discuss as part of my current care plan?
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
To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.