A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

May 8, 2012 updated by: Avid Radiopharmaceuticals

An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Research Site
      • Scottsdale, Arizona, United States, 85252
        • Research Site
      • Sun City, Arizona, United States, 85210
        • Research Site
      • Tucson, Arizona, United States, 85741
        • Research Site
    • California
      • Costa Mesa, California, United States, 92626
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Research Site
    • Florida
      • Hallandale Beach, Florida, United States, 33064
        • Research Site
      • Miami Beach, Florida, United States, 33140
        • Research Site
      • St. Petersburg, Florida, United States, 33702
        • Research Site
      • Sunrise, Florida, United States, 33351
        • Research Site
      • West Palm Beach, Florida, United States, 33407
        • Research Site
    • New York
      • Albany, New York, United States, 12208
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Research Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria AD:

  • Male or female >=50 years of age
  • Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24

Inclusion Criteria MCI:

  • Male or female >=50 years of age
  • Have a Clinical Dementia Rating (CDR) of 0.5
  • MMSE >24

Normal subjects:

  • Male or female >=50 years of age
  • MMSE >=29
  • Normal on psychometric test battery at screening
  • Provide informed consent

Exclusion Criteria:

  • Have a history or current diagnosis of other neurologic disease
  • Have had or currently have a diagnosis of other neurodegenerative disease
  • Have participated in experimental therapy targeted to amyloid plaque

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy controls
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • Amyvid
  • 18F-AV-45
  • florbetapir
Experimental: AD subjects
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • Amyvid
  • 18F-AV-45
  • florbetapir
Experimental: MCI Subjects
MCI (mild cognitive impairment)
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • Amyvid
  • 18F-AV-45
  • florbetapir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Cortical to Cerebellum SUVR
Time Frame: 50-60 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.
50-60 min after injection
Qualitative Amyloid Image Assessment
Time Frame: 50-60 min after injection
Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
50-60 min after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Positive Florbetapir-PET Scans
Time Frame: 50-60 min after injection
Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.
50-60 min after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Estimate)

May 10, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-45-A05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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