NCT00076505

Brief Summary

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:

  • Physical examination, including evaluation of strength, feeling, coordination, and balance
  • Blood drawing: 150 milliliters (about 10 tablespoons) of blood will be drawn
  • Personal and family medical history
  • Consent to access medical records for research purposes Blood samples will be examined for:
  • Genetic analysis
  • Study of specific proteins and lipids
  • Study of mitochondria (parts of cells that make energy)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2004

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2006

Completed
Last Updated

July 2, 2017

Status Verified

November 30, 2006

First QC Date

January 23, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

MitochondriaProteasomeLipidPolymorphismGeneticParkinson's DiseaseParkinson DiseasePDHeredityParkinson Disease At RiskHealthy VolunteerHV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Leroy E, Boyer R, Auburger G, Leube B, Ulm G, Mezey E, Harta G, Brownstein MJ, Jonnalagada S, Chernova T, Dehejia A, Lavedan C, Gasser T, Steinbach PJ, Wilkinson KD, Polymeropoulos MH. The ubiquitin pathway in Parkinson's disease. Nature. 1998 Oct 1;395(6701):451-2. doi: 10.1038/26652. No abstract available.

    PMID: 9774100BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 23, 2004

First Posted

January 26, 2004

Study Start

January 14, 2004

Study Completion

November 30, 2006

Last Updated

July 2, 2017

Record last verified: 2006-11-30

Locations