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

Avid Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: florbetapir F 18

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00857532

18F-AV-45-A12

5R43NS063607-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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31 participants in 3 patient groups

Normal cognitive performance

Experimental group

Description:

Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores of ≥9, indicating normal cognitive performance.

Treatment:

Drug: florbetapir F 18

Mild cognitive deficits

Experimental group

Description:

Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores between 6 and 8, inclusive, indicating mild cognitive deficits.

Treatment:

Drug: florbetapir F 18

Severe cognitive impairment

Experimental group

Description:

Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores below 5, indicating moderate to severe cognitive impairment.

Treatment:

Drug: florbetapir F 18