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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)

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ClinicalTrials.gov Identifier: NCT00702143
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : May 3, 2012
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Drug: florbetapir F 18 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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)
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702143


Locations
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United States, Arizona
Research Site
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
United States, California
Research Site
Costa Mesa, California, United States, 92626
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06510
United States, Florida
Research Site
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
United States, New York
Research Site
Albany, New York, United States, 12208
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Research Site
Jenkintown, Pennsylvania, United States, 19046
United States, Vermont
Research Site
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Director: Chief Medical Officer Avid Radiopharmaceuticals
More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT00702143     History of Changes
Other Study ID Numbers: 18F-AV-45-A05
First Posted: June 20, 2008    Key Record Dates
Results First Posted: May 3, 2012
Last Update Posted: May 10, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders