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)
This study has been completed.
Sponsor:
Avid Radiopharmaceuticals
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00702143
First received: June 19, 2008
Last updated: May 8, 2012
Last verified: May 2012
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (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
Drug Information available for:
Florbetapir F-18
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 ] [ Designated as safety issue: No ]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 ] [ 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.
Secondary Outcome Measures:
- Proportion of Positive Florbetapir-PET Scans [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]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:
|
|
Experimental: MCI Subjects
MCI (mild cognitive impairment)
|
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
|
| Experimental: Healthy controls |
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
|
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 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
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
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 |
| Results First Received: | April 6, 2012 |
| Last Updated: | May 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Cognition Disorders Mild Cognitive Impairment Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Dementia Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies |
ClinicalTrials.gov processed this record on February 27, 2015