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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
florbetapir F 18
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring amyloid burden, Parkinson's disease, florbetapir PET, amyloid PET imaging

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Normal cognitive performance

Mild cognitive deficits

Severe cognitive impairment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Mean Cortical Amyloid Burden
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 Outcome Measures

Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.
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
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.

Full Information

First Posted
March 5, 2009
Last Updated
February 1, 2013
Sponsor
Avid Radiopharmaceuticals
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00857532
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
amyloid burden, Parkinson's disease, florbetapir PET, amyloid PET imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal cognitive performance
Arm Type
Experimental
Arm Description
Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores of ≥9, indicating normal cognitive performance.
Arm Title
Mild cognitive deficits
Arm Type
Experimental
Arm Description
Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores between 6 and 8, inclusive, indicating mild cognitive deficits.
Arm Title
Severe cognitive impairment
Arm Type
Experimental
Arm Description
Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores below 5, indicating moderate to severe cognitive impairment.
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
18F-AV-45, Amyvid, florbetapir
Intervention Description
10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection
Primary Outcome Measure Information:
Title
Mean Cortical Amyloid Burden
Description
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.
Time Frame
50-60 min after injection
Secondary Outcome Measure Information:
Title
Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.
Description
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.
Time Frame
50-60 min after injection
Title
Correlation of Florbetapir SUVR With CSF Biomarker Values
Description
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.
Time Frame
50-60 min after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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