• PDtrials - Parkinson's Disease Clinical Trials
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Official Study Title: Biomarkers of Risk of Parkinson Disease
Sponsor: National Institute of Neurological Disorders and Stroke  National Institute of Neurological Disorders and Stroke (NINDS)A branch of the National Institutes of Health whose research concentrates on the brain and conditions that result in brain function irregularities. The NINDS funds much of the research on Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Internet address: http://www.ninds.nih.gov (NINDS)
Clinicaltrials.gov ID: NCT00775853
Study ID: 090010, 09-N-0010

Summary

This study will test whether individuals with risk factors for Parkinson’s disease (PD) have abnormal values for biomarkers (objective features that can be used to measure the progress of a disease) that indicate loss of particular nerve cells in the brain and heart, and whether at-risk individuals with positive biomarkers develop PD within up to 7.5 years of follow-up.

The participants are individuals who may be at risk for developing PD, because of (a) genetic  GeneticReferring to a condition that is caused by a person's genes (heredity). risk, i.e., a family history of PD or genetic 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 (drop of blood pressure upon standing up, such as lightheadness or loss of consciousness). A total of up to 100 confirmed at-risk participants undergo testing by brain and cardiac scanning. At-risk participants with positive biomarkers are compared to at-risk participants without positive biomarkers, in terms of development of PD during follow-up.

The study includes four phases: registration, screening,  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. laboratory biomarkers testing, and follow-up. A screening examination is done at the NIH Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Center, to confirm risk status. Based on the screening examination results, participants undergo clinical laboratory testing. In the follow-up phase, participants are re-tested approximately every 18 months for a total of up to five re-evaluations (90 months, or 7.5 years), to detect onset of the characteristic movement disorder in PD.

Please read more about this study and enroll via this website: https://pdrisk.ninds.nih.gov.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• More than six months
• Varies by participant. Inquire with study coordinator.

Eligibility

• Minimum Age: 18
• Maximum Age: 70
• Gender(s) Accepted: Either

Inclusion Criteria

Individuals with one or more of the following characteristics will be considered to be at risk and eligible for entering the Screening Examination phase. Priority will go to those with multiple risk factors. People with at least 3 of the 4 risk factors will be invited to the Screening. Control participants will have none of these characteristics:

• Genetic risk is assessed at the time of the Screening Examination in two ways-- by creation of a pedigree and by genotyping. The pedigree shows diagrammatically the family history with respect to PD. Genotyping is by DNA extraction and analysis for mutations of the LRRK2 gene,  GeneUnits of heredity that are made of DNA and contained in every cell. They produce proteins that control biological development and function. or the alpha-synuclein gene, or for alpha-synuclein gene replication. Either a positive family history (one or more immediate family members with PD) or positive DNA test results (LRRK2 or alpha-synuclein) satisfy the risk factor criterion for genetic risk. Other DNA analyses may be done subsequently; however, those results will not be considered relevant to genetic risk at the time of entry.  
  
• Decreased olfactory function (sense of smell) satisfies this risk factor criterion. In the event of a medical history indicating a secondary cause of decreased olfaction, decreased olfactory function is not be taken as satisfying this risk factor criterion.  
  
• REM Behavior Disorder (RBD) is identified by a history of sleep-related, injurious, potentially injurious, or disruptive behaviors (i.e., dream enactment behavior). The occurrence of these sleep-related abnormal behaviors is considered necessary and sufficient to satisfy the risk factor criterion. To satisfy the risk factor criterion, the individual must have movements of the body or limbs associated with dreaming and at least one of the following: potentially harmful sleep behavior, dreams that appear to be acted out, and sleep behavior that disrupts sleep continuity.
  
• Orthostatic Hypotension is assessed by measurement of the blood pressure after the person has been at rest (lying down) for at least 15 minutes and then after the subject has stood upright for 5 minutes.
  

Exclusion Criteria

• Age - People younger than 18 years old or older than 70 years old are excluded.
  
• Risk - A candidate is excluded if, in the judgment of the Principal Investigator,  Principal InvestigatorPerson responsible for management of a clinical trial, ensuring it is conducted in compliance with the study protocol. protocol  ProtocolA plan that is the basis for the conduct of a clinical trial ensuring the health of participants, and the solutions to specific research questions. A protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications and dosages, and the length of the study. participation would place the person at substantially increased medical risk. This includes the risks associated with air travel to the NIH. A candidate is excluded if, in the opinion of the Principal Investigator, the medical risk outweighs the potential scientific benefit.
  
• Disqualifying Conditions - A candidate is excluded if there is a disqualifying condition. Examples of disqualifying conditions are insulin-dependent diabetes, hepatic (kidney) or renal (liver) failure, symptomatic congestive heart failure, severe anemia, psychosis,  PsychosisA loss of contact with reality often accompanied by hallucinations. Psychosis can be caused by some PD medications and is more common in patients with advanced Parkinson's. ventricular arrhythmias, and symptomatic coronary heart disease. Persons with dementia  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. interfering with their ability to provide informed consent  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. are excluded. If a person develops dementia during the study, the person is excluded from further participation in the study. Persons who are unable to undergo MRI safely, due to implanted metal, are excluded.
  
• Medications - A candidate is excluded if clinical considerations require continued treatment with a drug likely to interfere with the scientific results. Chronic, ongoing use of drugs such as tricyclic antidepressants that affect the clinical laboratory results exclude candidates. People with known or suspected allergy or hypersensitivity to any test drug are excluded. Candidates are not to discontinue any medications before discussion with the Principal Investigator, Research Nurse, Nurse Practitioner, or Clinical Fellow. If it is decided that discontinuing medications would be unsafe, then the person is excluded from the study.
  
• Herbal Medicines and Dietary Supplements - If a person wishes to continue herbal medicines or dietary supplements while on study, and search of the available medical literature fails to identify effects that are known or expected to interfere with the experimental results, then the person may participate, at the discretion of Principal Investigator.
  
• Practical Limitations - People in whom the Investigator feels it would be difficult to insert a catheter into a vein may be excluded. People who are not expected clinically to tolerate lying still supine during the testing may be excluded. People also may be excluded if they cannot tolerate having an MRI or having a lumbar puncture.
  
• Pregnancy - Pregnant or lactating women are excluded. Women of childbearing potential must have a negative urine or blood test for pregnancy done within 24 hours before any testing involving radioactivity.
  

Enrollment

Expected Enrollment: 220 (US)
Date Enrollment Began: Oct 2008
Date Enrollment Ends: Sep 2011
Last Updated Date: Apr 22 2009
Trial Post Date: Apr 17 2009
Website: https://pdrisk.ninds.nih.gov/

Primary Contacts and Locations

Maryland

• David S. Goldstein — Principal Investigator
  goldsteind@ninds.nih.gov
  Phone: (301) 496-2103
  National Institutes of Health  National Institutes of Health (NIH)The National Institutes of Health, a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Headquartered in Bethesda Maryland, it is composed of 27 Institutes and Centers and provides leadership and financial support to researchers in every state and throughout the world. Internet address: http://www.nih.gov. Clinical Center
  9000 Rockville Pike
  Bethesda, MD 20892
  USA
  
• Patient Recruitment and Public Liaison Office
  prpl@mail.cc.nih.gov
  Phone: (800) 411-1222
  National Institutes of Health Clinical Center
  9000 Rockville Pike
  Bethesda, MD 20892
  USA