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

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: florbetapir F 18	Phase 2


Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Florbetapir F-18

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:

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.
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:

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.


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

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
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

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, see Learn About Clinical Studies.

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

Locations


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


Study Director:	Chief Medical Officer	Avid Radiopharmaceuticals

More Information


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
Results First Received:	April 6, 2012
Last Updated:	May 8, 2012

Additional relevant MeSH terms:


Alzheimer Disease Cognition Disorders Mild Cognitive Impairment Dementia Brain Diseases Central Nervous System Diseases	Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on August 23, 2017