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A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers

Phase 1
Completed
Conditions
Alzheimer's Disease
Interventions
Registration Number
NCT01565343
Lead Sponsor
Avid Radiopharmaceuticals
Brief Summary

This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Healthy controlsflorbetapir F 18Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart
AD Subjectsflorbetapir F 18Two bolus IV injections followed by brain PET scan up to 4 weeks apart
AD Subjects: Slow vs. Fast Bolusflorbetapir F 18Two bolus IV injections followed by a brain PET scan up to 4 weeks apart. The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
Primary Outcome Measures
NameTimeMethod
Mean Cortical to Cerebellum SUVR50-70 min after injection

Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Research Site

🇺🇸

North East, Maryland, United States

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