Protocol Number: 09-N-0010

Title:

Biomarkers of Risk of Parkinson Disease

Number:

09-N-0010

Summary:

Objective: This Protocol is to test whether individuals with putative risk factors for Parkinson disease (PD) have abnormal values for biomarkers of central or peripheral catecholaminergic innervation and whether at-risk individuals with positive biomarkers develop PD within up to 7.5 years of follow-up.

Study Population: The subjects are individuals who may be at risk for developing PD, because of (a) genetic risk-i.e., a family history of PD or genotypic abnormalities known to be associated statistically with PD; (b) olfactory dysfunction-i.e., decreased ability to distinguish among odors; (c) symptomatic rapid eye movement (REM) sleep behavior disorder (RBD); or (d) orthostatic hypotension. A total of 200 at-risk subjects undergo catecholaminergic biomarker testing by 6-[18F]fluorodopa brain and 6-[18F]fluorodopamine cardiac scanning. At-risk subjects with positive biomarkers are compared to at-risk subjects without positive biomarkers, in terms of development of PD during follow-up. Up to 20 control subjects are included, to add to a database of normal values for catecholaminergic biomarkers.

Design: The study includes four phases-recruitment, screening, laboratory biomarkers testing, and follow-up. Recruitment is by advertisement and a web site questionnaire of self-reported risk. A screening examination is done at the NIH Clinical Center, to confirm risk status. Based on the screening examination results, subjects undergo clinical laboratory testing, to identify central and peripheral catecholaminergic denervation. In the follow-up phase, subjects are re-tested approximately every 18 months for a total of up to 5 re-evaluations (90 months, or 7.5 years), to detect onset of the characteristic movement disorder in PD and follow the status of catecholaminergic innervation.

Outcome Measures:

Primary: Diagnosis of PD by a board certified neurologist who is blinded to risk factor status and the results of catecholaminergic biomarkers testing. If PD diagnosed, time to diagnosis.

Secondary: UPDRS; 6-[18F]fluorodopa brain scanning, 6-[18F]fluorodopamine cardiac scanning; CSF and plasma neurochemicals; neuropsychological rating scales; autonomic function testing; restrospective CSF proteomics; restrospective DNA analyses

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Recruitment has not started

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Biomarkers

Catecholamines

18F-Fluoro-L-dopa

Fluorodopamine

Parkinson's Disease

Recruitment Keyword(s):

Parkinson Disease

PD

Condition(s):

Parkinson Disease

Autonomic Nervous System Diseases

Pure Autonomic Failure

Investigational Drug(s):

6-[18F]Fluorodopamine

6-[18F]Fluorodopa

13N-Ammonia

Investigational Device(s):

None

Interventions:

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Hornykiewicz O. Biochemical aspects of Parkinson's disease. Neurology. 1998 Aug;51(2 Suppl 2):S2-9.

Goldstein DS, Holmes C, Sato T, Bernson M, Mizrahi N, Imrich R, Carmona G, Sharabi Y, Vortmeyer AO. Central dopamine deficiency in pure autonomic failure. Clin Auton Res. 2008 Apr;18(2):58-65.

Zarow C, Lyness SA, Mortimer JA, Chui HC. Neuronal loss is greater in the locus coeruleus than nucleus basalis and substantia nigra in Alzheimer and Parkinson diseases. Arch Neurol. 2003 Mar;60(3):337-41.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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