Clinical Trial: Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Trial of Florbetapir F18 PET Imaging of β-amyloid in Parkinson's Disease Patients With Cognitive Impairment

Brief Summary: The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.

Detailed Summary:
Sponsor: Avid Radiopharmaceuticals

Current Primary Outcome: Mean Cortical Amyloid Burden [ Time Frame: 50-60 min after injection ]

Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here.


Original Primary Outcome: Blinded image reading to determine the mean cortical target binding (average SUVR of frontal cortex, temporal cortex, parietal cortex, posterior cingulate cortex and precuneus) in PD patients compared to that of controls. [ Time Frame: ~15 months, following the enrollment of all subjects in the study ]

Current Secondary Outcome:

  • Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline. [ Time Frame: 50-60 min after injection ]
    Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function.
  • Correlation of Florbetapir SUVR With CSF Biomarker Values [ Time Frame: 50-60 min after injection ]
    Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables.


Original Secondary Outcome:

Information By: Avid Radiopharmaceuticals

Dates:
Date Received: March 5, 2009
Date Started: January 2009
Date Completion:
Last Updated: February 1, 2013
Last Verified: February 2013