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| Sponsored by: |
National Human Genome Research Institute (NHGRI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00076505 |
Purpose
This study will examine and compare blood samples from healthy volunteers and patients with Parkinson's disease to identify abnormalities associated with Parkinson's disease. Disease symptoms include slowness of movement, hand or leg shaking, and stiffness. Some patients have difficulty with balance. Information from this study may provide information on how Parkinson's disease affects the brain and body, and may help lead to a test for earlier diagnosis.
Healthy volunteers and patients with Parkinson's disease who are 18 years of age or older may enroll in this study. Participants will undergo the following procedures:
Blood samples will be examined for:
| Condition |
|---|
|
Parkinson Disease |
| Study Type: | Observational |
| Official Title: | Bioenergetic Function in Parkinson's Disease |
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | November 2006 |
This study wants to focus on mitochondrial defects associated with Parkinson's disease (PD) and how they relate to alpha-synuclein (SNCA) expression and function. Individuals from families with inherited Parkinson's disease (affected and at risk members), as well as normal individuals, will be enrolled. All subjects will be asked to provide blood samples in order to study bioenergetic function in mitochondria from their platelets. These studies will include genotyping and determination of polymorphisms in the subjects' mitochondrial DNA (mtDNA) in order to delineate any significant abnormality that may be associated with a particular group. Cardiolipin levels will be obtained fee for service at Lipomics. Basic respirometry, enzyme activity, and somatic cell hybridization will be performed in the PI's lab. Protein analysis will be performed in the proteomics facility at NIMH.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Individuals over the age of 18 from families in which an inherited form of parkinson's disease is apparent will be enrolled. These patients are already enrolled in the Genetic linkage analysis protocol 97-HG-0173.
The diagnosis of Parkinson's disease must be supported by accepted clinical criteria including: tremor, bradykinesia, rigidity and responsiveness to L-DOPA.
Unaffected family members found to be at risk, will also be enrolled.
The normal control group will be comprised of anonymous platelet donors from the NIH Department of Transfusion Medicine and of individuals over the age of 18 with no known neurological disorder and normal neurological examination matched by age and sex that may be actively recruited.
Individuals with Lewy Body disease (LBD) that meet current criteria for diagnosis (hallucinations, diurnal variation, and dementia associated with extrapyramidal symptoms within a one year period) will also be included in the study.
EXCLUSION CRITERIA:
Because some medications can alter mitochondrial function, patients on MAO inhibitors, antidiabetic sulfonylureas and benzodiazepines will be excluded from the study.
No person under the age of 18 will be enrolled in this study. This is due to the fact that, except for very rare occasions, Parkinson's disease affects only adults.
Contacts and Locations More Information
| Study ID Numbers: | 040092, 04-HG-0092 |
| Study First Received: | January 23, 2004 |
| Last Updated: | March 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00076505 |
| Health Authority: | United States: Federal Government |
|
Mitochondria Proteasome Lipid Polymorphism Genetic Parkinson's Disease |
Parkinson Disease PD Heredity Parkinson Disease At Risk Healthy Volunteer HV |
|
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases Central Nervous System Diseases |
Healthy Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
|
Nervous System Diseases |
