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

NCT00857532 | Completed Phase 2 Results

• 2 other identifiers: 18F-AV-45-A125R43NS063607-02
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

amyloid burden; Parkinson's disease; florbetapir PET; amyloid PET imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  50-60 min after injection

Secondary Outcomes (2)

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

  50-60 min after injection

• Correlation of Florbetapir SUVR With CSF Biomarker Values

  50-60 min after injection

Study Arms (3)

Normal cognitive performance

EXPERIMENTAL

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

Drug: florbetapir F 18

Mild cognitive deficits

EXPERIMENTAL

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

Severe cognitive impairment

EXPERIMENTAL

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

Drug: florbetapir F 18

Interventions

florbetapir F 18 DRUG

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

Also known as: 18F-AV-45, Amyvid, florbetapir

Mild cognitive deficits; Normal cognitive performance; Severe cognitive impairment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avid Radiopharmaceuticals, Inc.

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 11, 2013
• Results First Posted: March 11, 2013

Record last verified: 2013-02

Locations

US (1)