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Official Study Title: Florbetapir F 18 PET Imaging of Beta-Amyloid in 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. Patients
Sponsor: Avid Radiopharmaceuticals
Clinicaltrials.gov ID: NCT00857532
Study ID: 18F-AV-45-A12

Summary

The primary aim of this study is to compare regional amyloid burden (the amount of amyloid in the brain) in people with PD as well as people without PD acting as controls. Amyloid is a protein that gets deposited in the brain of people with Alzheimer’s disease and may be the cause of cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. problems in people with other disorders. Investigators hypothesize that there will be significant differences in overall amyloid burden in people with PD compared to people without PD of similar age.

This cross-sectional clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. study will be performed with florbetapir F 18 (18F-AV-45 Injection) followed by brain PET imaging in people with PD with a range in severity of cognitive impairment.  18F-AV-45 is an experimental radiology tracer that detects amyloid.  PET imaging refers to Positron Emission Tomography, a highly specialized imaging technique that uses short-lived radioactive substances to produce three-dimensional colored images of those substances functioning within the body. People with PD will have PET imaging with 18F-AV-45 to look for amyloid deposits in the brain.  Results from PET imaging studies for PD participants will be compared to 18F-AV-45 PET results for age and sex matched non-PD participants drawn from an existing database. Within PD participants, correlations between 18F-AV-45 imaging results and clinical tests of motor and neuropsychological function will be made.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Less than one month
• One time visit.

Eligibility

• Minimum Age: 60
• Gender(s) Accepted: Either

Inclusion Criteria

People may be enrolled if they:

• Meet research diagnostic criteria for Parkinson's disease
• Have been diagnosed with a parkinsonian syndrome
• Have excellent response to levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. with dyskinesias
• Have been levodopa responsive for 5 years or more
• Have been on a clinical course of 10 years or more
• Have the ability to lie flat and tolerate a 10-minute PET scan
  

Exclusion Criteria

People may not be enrolled if any of the following have:

• History of repeated strokes, repeated head injury, definite encephalitis
• Used neuroleptics (anti-psychotic medications) at onset of symptoms
• Sustained remission (disappearance of signs or symptoms)
  Strictly one-sided symptoms persisting more than three years after onset
• Significant supranuclear gaze palsy
• Cerebellar, pyramidal and early severe findings of the autonomic nervous system  Autonomic Nervous SystemControls automatic functions, such as heartbeat, digestion, salivation, and blood pressure. as determined by the investigators
• Early severe dementia  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. suggesting a diagnosis of dementia with Lewy bodies (DLB)
• Imaging study showing abnormality that could explain parkinsonism
• Negative response to an adequate levodopa trial
• Current clinically significant psychiatric disease that prohibits providing 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. or participation in the study
• Current clinically significant endocrine or metabolic disease, pulmonary disease
• If women, childbearing potential
• Received any investigational medications, or have participated in a trial with investigational medications within the last 30 days
  

Enrollment

Expected Enrollment: 35 (US)
Date Enrollment Began: Jan 2009
Date Enrollment Ends: Oct 2011
Last Updated Date: May 12 2011
Trial Post Date: Jul 08 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00857532?term=NCT00857532&rank=1

Primary Contacts and Locations

Pennsylvania

• Michael J Pontecorvo, PhD
  Avid Radiopharmaceuticals
  pontecorvo@avidrp.com
  Phone: (215) 966-6221
  Philadelphia, PA 19104
  USA
  
• Christopher M Clark, MD
  Avid Radiopharmaceuticals
  clark@avidrp.com
  Phone: (215) 966-6123
  Philadelphia, PA 19104
  USA
  
• Andrew Siderowf, MD — Principal Investigator
  University of Pennsylvania
  Phone: (215) 829-7374
  PA
  USA