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Completed

NCT Number: NCT00857532

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects may be enrolled if they (inclusion criteria):
  • Are males or females ≥60 years of age
  • Meet research diagnostic criteria for Parkinson's disease:
  • Diagnosis of a parkinsonian syndrome
  • Bradykinesia (slowness of initiation of voluntary movement with progressive reduction in speed and amplitude of repetitive actions)
  • At least one of the following: muscle rigidity, rest tremor, postural instability not due to visual, vestibular, cerebellar or proprioceptive causes
  • Supportive criteria for diagnosis of PD (two or more required)
  • Unilateral onset of symptoms and persistent asymmetry
  • Rest tremor present
  • Progressive illness
  • Excellent response to levodopa with dyskinesias
  • Levodopa response for 5 years or more
  • Clinical course of 10 years or more
  • Have the ability to lie flat and tolerate a 10 minute PET scan.

Exclusion criteria

  • Subjects may not be enrolled if any of the following are present (exclusion criteria):
  • History of repeated strokes, repeated head injury, definite encephalitis
  • Use of neuroleptics at onset of symptoms
  • Sustained remission
  • Strictly unilateral feature persisting > three years after onset
  • Significant supranuclear gaze palsy
  • Cerebellar, pyramidal and early severe autonomic findings
  • Early severe dementia suggesting a diagnosis of dementia with Lewy bodies (DLB)
  • Imaging study showing structural abnormality that could explain parkinsonism
  • Negative response to an adequate levodopa trial
  • Current clinically significant psychiatric disease that prohibits providing informed consent or participation in the study
  • Current clinically significant endocrine or metabolic disease, pulmonary,
  • Women of childbearing potential who are not two or more years post menopausal or surgically sterilized
  • Have received any investigational medications, or have participated in a trial with investigational medications within the last 30 days

Treatment and study plan

florbetapir F 18

Drug

10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection

Other names: 18F-AV-45, Amyvid, florbetapir

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2009
Registry last updated
Mar 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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