Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI and AD Subjects
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| ClinicalTrials.gov Identifier: NCT02016560 |
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Recruitment Status :
Completed
First Posted : December 20, 2013
Last Update Posted : October 25, 2018
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Sponsor:
Avid Radiopharmaceuticals
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
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Brief Summary:
This is a cross-sectional and longitudinal study that will evaluate imaging characteristics of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and Alzheimer's disease (AD) subjects.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: florbetapir F 18 Drug: 18F-AV-1451 | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 383 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | All subjects in both the exploratory and confirmatory phases of the study, receive both AV-1451 and florbetapir scans, regardless of subgroup assignment. |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official Title: | An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease |
| Actual Study Start Date : | December 2013 |
| Actual Primary Completion Date : | July 28, 2017 |
| Actual Study Completion Date : | July 28, 2017 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Alzheimer disease
Drug Information available for:
Florbetapir F-18
| Arm | Intervention/treatment |
|---|---|
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Experimental: Exploratory Cognitively Healthy Subjects
Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose of florbetapir F 18 at baseline. Cross-sectional and longitudinal subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline. Longitudinal subjects only will receive an IV injection, 370 MBq (10 mCi) of 18F-AV-1451 at 9 and 18 months.
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Drug: florbetapir F 18
Other Names:
Drug: 18F-AV-1451 Other Name: T807 |
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Experimental: Exploratory MCI Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline, 9 months and 18 months.
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Drug: florbetapir F 18
Other Names:
Drug: 18F-AV-1451 Other Name: T807 |
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Experimental: Exploratory AD Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of 18F-AV-1451 at baseline, 9 months and 18 months.
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Drug: florbetapir F 18
Other Names:
Drug: 18F-AV-1451 Other Name: T807 |
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Experimental: Confirmatory Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and 18F-AV-1451 at baseline.
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Drug: florbetapir F 18
Other Names:
Drug: 18F-AV-1451 Other Name: T807 |
Primary Outcome Measures :
- Cross-sectional 18F-AV-1451 Imaging Results [ Time Frame: 80-130 minutes post injection ]Compare standard uptake value ratio (SUVR) in subjects with AD to subjects with MCI and cognitively healthy older individuals.
- Change in tau deposition over time [ Time Frame: 18 months ]Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake (SUVR) over time.
Secondary Outcome Measures :
- 18F-AV-1451 imaging in healthy individuals [ Time Frame: 80-130 minutes post-injection ]Describe the tau SUVR distribution across age groups among cognitively healthy subjects.
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Exploratory Cognitively Healthy Subjects
- ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
- Mini-mental state examination (MMSE) ≥ 29
- No significant history of cognitive impairment
Exploratory MCI Subjects
- ≥ 50 years of age
- MMSE ≥ 24
- Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
- Have a study partner that can report on subject's activities of daily living
Exploratory AD Subjects
- ≥ 50 years of age
- MMSE > 10
- Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD
- Have a study partner that can report on subject's activities of daily living
Confirmatory Subjects
- ≥ 50 years of age
- MMSE ≥ 20 and ≤ 27
- Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause
- Have a study partner that can report on subject's activities of daily living
Exclusion Criteria:
- Current clinically significant psychiatric disease
- Evidence of structural brain abnormalities
- History of moderate or severe traumatic brain injury
- Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- History of alcohol or substance abuse or dependence
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have received or participated in a trial with investigational medications in the past 30 days
- Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
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): NCT02016560
Locations
| United States, Arizona | |
| Banner Alzheimer's Institute | |
| Phoenix, Arizona, United States, 85006 | |
| Four Peaks Neurology | |
| Scottsdale, Arizona, United States, 85258 | |
| Mayo Clinic | |
| Scottsdale, Arizona, United States, 85259 | |
| Banner Sun Health Research Institute | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| UC Irvine | |
| Irvine, California, United States, 92697 | |
| Hoag Memorial | |
| Newport Beach, California, United States, 92663 | |
| Norther California PET Imaging Center | |
| Sacramento, California, United States, 95816 | |
| UC Davis | |
| Sacramento, California, United States, 95817 | |
| UC San Francisco | |
| San Francisco, California, United States, 94158 | |
| Neurological Research Institute | |
| Santa Monica, California, United States, 90404 | |
| United States, Connecticut | |
| Molecular NeuroImaging | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Quantum Laboratories | |
| Deerfield Beach, Florida, United States, 33064 | |
| 21st Century Oncology | |
| Fort Myers, Florida, United States, 33912 | |
| Sandlake Imaging | |
| Orlando, Florida, United States, 32806 | |
| Meridien Research | |
| Saint Petersburg, Florida, United States, 33709 | |
| USF Health Byrd Alzheimer's Center | |
| Tampa, Florida, United States, 33613 | |
| Independent Imaging | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Boston University | |
| Boston, Massachusetts, United States, 02118 | |
| Alzheimer's Disease Center | |
| Quincy, Massachusetts, United States, 02169 | |
| United States, Missouri | |
| Center for Clinical Imaging Research | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Las Vegas Radiology | |
| Las Vegas, Nevada, United States, 89147 | |
| United States, New York | |
| Center for Brain Health - NYU Langone Medical Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| Butler Hospital | |
| Providence, Rhode Island, United States, 02906 | |
Sponsors and Collaborators
Avid Radiopharmaceuticals
| Responsible Party: | Avid Radiopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02016560 History of Changes |
| Other Study ID Numbers: |
18F-AV-1451-A05 |
| First Posted: | December 20, 2013 Key Record Dates |
| Last Update Posted: | October 25, 2018 |
| Last Verified: | October 2018 |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |