Imaging and Genetic Biomarkers of Parkinson Disease (PD) Onset and Progression in High-risk Families

Completed · Phase 2

Conditions studied: Parkinson Disease, Parkinsonian Syndrome

In brief

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by rigidity, bradykinesia, postural instability, and tremor. Clinical decline reflects ongoing degeneration of dopamine-containing neurons. A critical unmet need for clinical research is to improve early detection of these diseases by developing tools to assist with earlier diagnosis. Biomarkers are broadly defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (Biomarkers Defintions Working Group 2001). Development of reliable biomarkers for PD would dramatically accelerate research on PD etiology, pathophysiology, disease progression and therapeutics. Specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression. The biomarkers in this study include brain imaging with a radioactively labelled drug (Beta-CIT), computerized testing of memory, attention, motor speed, judgment and handwriting, and assessments of speech and smell. Subjects may also be asked to provide a blood sample for genetic and biochemical testing.

Key facts

Study ID

NCT00273351

Run by

Institute for Neurodegenerative Disorders

People needed

62

Starts

2006-01-01

Expected to finish

2008-01-01

Last updated by the study team

2014-05-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >21
• Previous participation in the Progeni or Core PD clinical study
• A diagnosis of parkinsonism or a family history of parkinsonism
• Normal screening laboratory studies including:
• complete blood count
• chemistries
• urinalysis

You may not qualify if…

• Pregnancy
• Psychiatric disease other than history of depression
• Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal ECG.

Where it is running

• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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