Evaluation of PET Scan Timing Relative to AV-45 Injection Time

Comparison of PET Images Acquired at 30 Min and 50 Min Post Injection of 18F-AV-45 in Healthy Volunteers and Alzheimer's Disease Patients

This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: florbetapir F 18

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330).

Inclusion Criteria (AD group):

• Greater than 50 years of age
• Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
• Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
• History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (A01[NCT01565291] healthy volunteer group):

• 50 years of age, inclusive

  • MMSE of 29 or greater

Inclusion Criteria (A03[NCT01565330] healthy volunteer group):

• 35 to 55 years of age, inclusive
• MMSE of 29 or greater

Exclusion Criteria (both groups):

• Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
• Diagnosis of other dementing / neurodegenerative disease
• Diagnosis of mixed dementia
• Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
• Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
• Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
• Clinically significant psychiatric disease
• History of epilepsy or convulsions
• Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
• Current clinically significant cardiovascular disease
• Received investigational medication within the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation	Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.	Scans acquired 30-40 min and 50-60 min after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation	Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.	Scans acquired 30-40 min and 50-60 min post-injection

Collaborators and Investigators

• Sponsor: Avid Radiopharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 7, 2012
• Last Update Submitted That Met QC Criteria: May 3, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Diagnostic imaging; Positron Emission Tomography; Amyloid imaging; 18F-AV-45; florbetapir F 18
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 18F-AV-45-A06