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)
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ClinicalTrials.gov Identifier: NCT00702143 |
Recruitment Status :
Completed
First Posted : June 20, 2008
Results First Posted : May 3, 2012
Last Update Posted : May 10, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease Mild Cognitive Impairment | Drug: florbetapir F 18 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 184 participants |
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) |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: AD subjects |
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
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Experimental: MCI Subjects
MCI (mild cognitive impairment)
|
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
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Experimental: Healthy controls |
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
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- 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.
- 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.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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): NCT00702143
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 |
Study Director: | Chief Medical Officer | Avid Radiopharmaceuticals |
Responsible Party: | Avid Radiopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00702143 |
Other Study ID Numbers: |
18F-AV-45-A05 |
First Posted: | June 20, 2008 Key Record Dates |
Results First Posted: | May 3, 2012 |
Last Update Posted: | May 10, 2012 |
Last Verified: | May 2012 |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |