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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01565343
First received: March 26, 2012
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
 Drug: florbetapir F 18
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Test-retest Reproducibility of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Alzheimer's Disease Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Mean Cortical to Cerebellum SUVR [ Time Frame: 50-70 min after injection ] [ Designated as safety issue: No ]
    Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.


Enrollment: 25
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AD Subjects
Two bolus IV injections followed by brain PET scan up to 4 weeks apart
 Drug: florbetapir F 18
IV injection, 370MBq (10mCi)
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Experimental: AD Subjects: Slow vs. Fast Bolus

Two 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).

 Drug: florbetapir F 18
IV injection, 370MBq (10mCi)
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Experimental: Healthy controls
Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart
 Drug: florbetapir F 18
IV injection, 370MBq (10mCi)
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565343

Locations
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06510
United States, Florida
Research Site
Hallandale Beach, Florida, United States, 33009
Research Site
West Palm Beach, Florida, United States, 33407
United States, Maryland
Research Site
North East, Maryland, United States, 21901
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01565343     History of Changes
Other Study ID Numbers: 18F-AV-45-A04
Study First Received: March 26, 2012
Results First Received: April 6, 2012
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013