Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565330
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : May 2, 2012
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: An Open Label, Parallel Group, Dose Comparison of Safety and Imaging Characteristics of 111 and 370 MBq (3 and 10 mCi) of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Patients With Alzheimer's Disease (AD)
Study Start Date : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 111 MBq (3 mCi) AD Group
Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
 Drug: florbetapir F 18
single dose IV injection
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Experimental: 111 MBq (3 mCi) Control Group
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
 Drug: florbetapir F 18
single dose IV injection
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Experimental: 370 MBq (10 mCi) AD Group
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
 Drug: florbetapir F 18
single dose IV injection
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
Experimental: 370 MBq (10 mCi) Control Group
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18.
 Drug: florbetapir F 18
single dose IV injection
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Florbetapir-PET Scan Quality [ Time Frame: 0-90 min after injection ]
    Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).


Secondary Outcome Measures :
  1. Mean Cortical to Cerebellum SUVR [ Time Frame: 0-90 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page 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): NCT01565330


Locations
Layout table for location information
United States, Florida
Research Site
West Palm Beach, Florida, United States, 33407
United States, Maryland
Research Site
North East, Maryland, United States, 21901
United States, New Jersey
Research Site
Clementon, New Jersey, United States, 08021
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Layout table for investigator information
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01565330    
Other Study ID Numbers: 18F-AV-45-A03
First Posted: March 28, 2012    Key Record Dates
Results First Posted: May 2, 2012
Last Update Posted: June 18, 2012
Last Verified: June 2012
Keywords provided by Avid Radiopharmaceuticals:
Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders