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) - Full Text View

Sponsor:	Avid Radiopharmaceuticals
Information provided by (Responsible Party):	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00702143

Purpose

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	Intervention	Phase
Alzheimer's Disease Mild Cognitive Impairment	Drug: 18F-AV-45	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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)

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Mild Cognitive Impairment Nuclear Scans

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:

Presence or absence of amyloid plaque on the 18F-AV-45 PET scan as determined by image readers blinded to all clinical information. Safety evaluations of subjects undergoing AV-45 PET scan. [ Time Frame: at close of enrollment for study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine rates of AV-45 PET scan positivity in AD, MCI and healthy normal subjects. [ Time Frame: at end of enrollment ] [ Designated as safety issue: No ]

Enrollment:	184
Study Start Date:	June 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Healthy control	Drug: 18F-AV-45 370 MBq
AD	Drug: 18F-AV-45 370 MBq
MCI	Drug: 18F-AV-45 370 MBq

Detailed Description:

Expand the safety database of 18F-AV-45 PET
Refine the definition of a normal 18F-AV-45 PET scan
Determine the range of amyloid positive PET scans with 18F-AV-45 in AD and MCI

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria AD:

Male or female >=50 years of age
Meet 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 pycnometric 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702143

Locations

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

Sponsors and Collaborators

Avid Radiopharmaceuticals

More Information

No publications provided

Responsible Party:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00702143 History of Changes
Other Study ID Numbers:	18F-AV-45-A05
Study First Received:	June 19, 2008
Last Updated:	November 21, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alzheimer Disease
Cognition Disorders
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 February 09, 2012