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Biomarkers of Risk of Parkinson Disease

NCT00775853 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89

Last updated 2025-09-19

No results posted yet for this study

Summary

This study (https://pdrisk.ninds.nih.gov) will determine if people who have risk factors for Parkinson disease (PD) have biomarkers (objective ways to measure a disease process) that show that the disease process is actually going on, and if people who have abnormal biomarkers go on to develop PD during several years of follow-up. Biomarkers of Parkinson disease (PD) might identify people who are healthy now but may develop the disease later in life.

Healthy volunteers and people who have certain risk factors for developing PD who are between 18 and 70 years of age may be eligible for this study. People with the following risk factors are included:

* Family history of PD
* Loss of sense of smell
* Fall in blood pressure when standing up
* REM behavior disorder (a type of sleep disturbance)

Participants undergo the following tests and procedures:

* Screening examination
* Medical and neurological history and physical examination
* Tests or rating scales for movement, sense of smell, mood, attention, fatigue, pain, and thinking.
* Measurement of blood pressure and pulse rate while lying down and then standing up
* Blood draw for genetic testing
* Inpatient testing at the NIH Clinical Center for 2-3 days, including:
* Measurements while blowing against a resistance
* Measurements of blood pressure and pulse rate
* Blood draws for levels of various chemicals
* PET and MRI scanning
* Lumbar puncture (spinal tap)
* Electrocardiogram
* Skin electrical conduction test (test of sweat production)
* Skin and core temperature measurements
* Transcranial ultrasound (sound-wave test of the head)
* Follow-up testing (up to five visits in 18-month intervals) to repeat some of the tests listed above, excluding the genetic testing and spinal tap

Conditions

  • Parkinson Disease
  • Autonomic Nervous System Diseases
  • Pure Autonomic Failure

Interventions

DRUG

6-[18F]Fluorodopamine

DRUG

6-[18F]Fluorodopa

DRUG

13N-Ammonia

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • David S Goldstein, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-27
Primary Completion
2023-01-11
Completion
2023-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00775853 on ClinicalTrials.gov