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A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers

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ClinicalTrials.gov Identifier: NCT01565291
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : May 3, 2012
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: florbetapir F 18 Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Preliminary Evaluation of the Amyloid Binding Properties, Pharmacokinetics and Safety of 18F-AV-45 in Healthy Elderly Volunteers and Patients With Alzheimer's Disease
Study Start Date : June 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Subjects With AD
Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24)
 Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Experimental: Healthy Elderly Subjects
Cognitively normal with MMSE of 29 or higher; age 50 years or older
 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. 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 cerebellum gray matter. Total scan length was 200 min.


Secondary Outcome Measures :
  1. Precuneus to Cerebellum SUVR [ Time Frame: 50-60 min after injection ]
    Ratio of uptake in the precuneus to uptake in the cerebellum.


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

Inclusion Criteria (AD group):

  • 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 exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
  • History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

  • No evidence of significant cognitive impairment by history and psychometric testing
  • MMSE of 29 or higher

Exclusion Criteria (both groups):

  • Neurodegenerative disorders other than AD
  • 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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01565291


Locations
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21287
Research Site
North East, Maryland, United States, 21901
United States, New Jersey
Research Site
Long Branch, New Jersey, United States, 07740
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01565291     History of Changes
Other Study ID Numbers: 18F-AV-45-A01
First Posted: March 28, 2012    Key Record Dates
Results First Posted: May 3, 2012
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging

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