Clinical trial NCT00857532: Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients
Official title: A Phase 2 Trial of Florbetapir F18 PET Imaging of β-amyloid in Parkinson's Disease Patients With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: amyloid burden
Parkinson's disease
florbetapir PET
amyloid PET imaging
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2009-03-06
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Cortical Amyloid Burden
timeFrame: 50-60 min after injection
Secondary outcomes:
measure: Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.
timeFrame: 50-60 min after injection
measure: Correlation of Florbetapir SUVR With CSF Biomarker Values
timeFrame: 50-60 min after injection
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: