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

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Drug: florbetapir F 18	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	A Phase 2 Trial of Florbetapir F18 PET Imaging of β-amyloid in Parkinson's Disease Patients With Cognitive Impairment

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Amyloidosis Diagnostic Imaging Parkinson's Disease

Drug Information available for: Florbetapir F-18

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:

Mean Cortical Amyloid Burden [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
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. [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.


Enrollment:	31
Study Start Date:	January 2009
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Normal cognitive performance Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores of ≥9, indicating normal cognitive performance.	Drug: florbetapir F 18 10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection Other Names: 18F-AV-45 Amyvid florbetapir
Experimental: Mild cognitive deficits Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores between 6 and 8, inclusive, indicating mild cognitive deficits.	Drug: florbetapir F 18 10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection Other Names: 18F-AV-45 Amyvid florbetapir
Experimental: Severe cognitive impairment Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores below 5, indicating moderate to severe cognitive impairment.	Drug: florbetapir F 18 10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection Other Names: 18F-AV-45 Amyvid florbetapir

Eligibility


Ages Eligible for Study:	60 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857532

Locations


United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Avid Radiopharmaceuticals

National Institutes of Health (NIH)

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators


Study Director:	Chief Medical Officer	Avid Radiopharmaceuticals

More Information


Responsible Party:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00857532 History of Changes
Other Study ID Numbers:	18F-AV-45-A12 5R43NS063607-02
Study First Received:	March 5, 2009
Results First Received:	November 30, 2012
Last Updated:	February 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:


amyloid burden Parkinson's disease florbetapir PET amyloid PET imaging

Additional relevant MeSH terms:


Parkinson Disease Amyloidosis Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases	Nervous System Diseases Movement Disorders Neurodegenerative Diseases Proteostasis Deficiencies Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2016