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PET Scanning in Parkinson's Disease



PET Scanning in Parkinson's Disease

For Condition: Parkinson Disease
Status: Recruiting
Sponsor(s): National Human Genome Research Institute (NHGRI) ,
Synopsis: This study will compare brain blood flow and the brain's use of dopamine in patients with Parkinson's disease, their family members and normal volunteers. Dopamine is a chemical normally found in the part of the brain involved in controlling movement. This chemical is lacking in people with Parkinson's disease, and patients have difficulty initiating or controlling some body movements. Usually, Parkinson's disease develops in people without any known cause. In a few families, however, three or more people are affected, suggesting these families may have a genetic alteration that makes them more prone to develop the disease. Normal healthy volunteers and members of families in which three or more people have Parkinson's disease may be eligible for this study. Candidates will have a physical examination and provide a personal and family medical history. Volunteers will also have a neurological examination. Participants will undergo PET scanning. One hour before the scan, subjects are given a medication called Carbidopa, which maximizes the usefulness of the scans. For the procedure, the subject lies on a table in the scanner, a catheter (thin plastic tube) is inserted into an arm vein, and a baseline scan is done. Radioactive water is then injected through the catheter and another scan is done. During this scan, the subject is asked questions to stimulate blood flow in certain areas of the brain. Up to 10 injections are given, with different questions asked each time. The total time for the scans is not more than 1 hour. A final scan, which may last up to 2 hours, is then done. Dopamine is injected into the catheter before the scan begins. When it is completed, subjects are instructed to empty their bladder immediately and then every 2 hours for the rest of the day to reduce the exposure to radioactive material. Shortly afterwards, the subject has a magnetic resonance imaging (MRI) scan. This scan is used to help interpret the information obtained from the PET scans. MRI uses radio waves and a magnetic field to image structural and chemical changes in tissues. For this procedure, the subject lies still on a table that is moved into the middle of a narrow circular scanner. An intercom system permits communication with the staff member performing the study at all times during the procedure.
Details: We propose an in vivo study of regional cerebral dopamine neurochemistry and blood flow in normal volunteers and individuals from families with inherited Parkinson's disease (PD), including clearly affected individuals, those with equivocal signs, and those at risk but showing no signs of the disease. Using positron emission tomography (PET) with 6-[F-18] Fluoro-L-dopa (6FD) and 15O-H2O in a single scan session, both cerebral blood flow and presynaptic dopaminergic function will be assessed. Comparisons between affected, unaffected, equivocally affected individuals and healthy volunteers will be made to note any abnormalities in striatal and putamenal presynaptic F-dopa uptake. Each subject will be further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scan. The results of the PET scan will help to phenotypically categorize clinically equivocal family members and strengthen the linkage analysis study in which they have already consented to participate by providing a quantitative trait that can be mapped rather than a strictly discrete qualitative trait (affected, unaffected). Information about the PET scan results will not be communicated back to the individuals or families involved as part of this study.
Eligibility:
Study Type:
  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Individuals over the age of 18 from families in which an autosomal dominant form of Parkinson's disease is suspected based on pedigree analysis. 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. EXCLUSION CRITERIA: Individuals not capable of understanding the consent will be excluded. Volunteers will be age, gender and handedness-matched for statistical purposes.
Total Enrollment: 200

Location and Contact Information:

National Human Genome Research Institute (NHGRI) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Aideen  McInerney-Leo 3014020160


Additional Information:
Study ID Numbers:
  010232;  01-HG-0232
Study Start Date: September 17, 2001
Record last reviewed: August 20, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024622

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