Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline
NCT ID: NCT01703702
Last Updated: 2016-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
641 participants
INTERVENTIONAL
2012-10-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Intervention
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
florbetapir (18F)
Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
Control
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
florbetapir (18F)
Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
Interventions
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florbetapir (18F)
Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Males or females ≥ 50 to \<= 90 years of age.
2. Have cognitive decline verified by a study partner or cognitive impairment verified by the study physician.
3. Have a study partner who provides separate consent and is willing to accompany the patient on all of the study visits.
4. Have an MMSE score of 24 to 30 inclusive.
5. Can tolerate a 10-minute PET scan.
6. Have the ability to cooperate and comply with all study procedures.
7. Have an enrolling physician who has less than high confidence in their diagnosis for the patient related to the cognitive decline at the time of enrollment.
8. Ability to provide informed consent for study procedures.
Patients may be enrolled in the dementia group if the following criteria are met:
1. Are males or females ≥ 50 to \<= 90 years of age.
2. Meet clinical criteria for dementia.
3. Have a caregiver who provides separate consent and is willing to accompany the patient on all of the study visits.
4. Have an MMSE score of 16 to 24 inclusive.
5. Have not received a clinical examination and/or laboratory test results that strongly indicates a non-neurodegenerative cause for the patients cognitive impairment.
6. Can tolerate a 10-minute PET scan.
7. Have the ability to cooperate and comply with all study procedures.
8. Have an enrolling physician who has less than high confidence in their diagnosis for the patient related to the cognitive decline at the time of enrollment.
9. Ability to provide informed consent for study procedures. (If the patient is incapable of giving informed consent, the patient's legal representative may consent on behalf of the patient but the patient must still confirm assent. This person may serve as the study partner as well).
Exclusion Criteria
1. Have a current serious or unstable illness;
2. The patient or enrolling physician knows the result of a previous amyloid imaging scan;
3. The patient has a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation;
4. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
5. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, γ -secretase or β -secretase inhibitor) unless it can be documented that the patient received only placebo during the course of the trial;
6. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
7. Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
Patients will also be excluded from enrollment if their enrolling physician:
1. Does not consider Alzheimer's disease as a potential cause of the patient's cognitive decline.
2. Is not the primary physician taking care of the patient with respect to the management of their cognitive impairment.
3. Cannot categorize the patient as either: a) having a documented and completed evaluation for cognitive decline within the past 18 months old; or b) currently undergoing evaluation for cognitive decline.
4. Is unwilling to suspend all testing and other evaluation procedures between the time of the baseline evaluation of the enrolling physician's diagnosis and management plan and the time the completion of the PET scan.
50 Years
90 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Avid Radiopharmaceuticals
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Sun City, Arizona, United States
Research Site
Clearwater, Florida, United States
Research Site
Miami Beach, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Chestnut Hill, Massachusetts, United States
Research Site
Quincy, Massachusetts, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Patchogue, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Providence, Rhode Island, United States
Research Site
Providence, Rhode Island, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Bennington, Vermont, United States
Research Site
Amiens, , France
Research Site
Bordeaux, , France
Research Site
Bron, , France
Research Site
Dijon, , France
Research Site
Lille, , France
Research Site
Marseille, , France
Research Site
Montpellier, , France
Research Site
Nancy, , France
Research Site
Nantes, , France
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Nice, , France
Research Site
Paris, , France
Research Site
Pessac, , France
Research Site
Reims, , France
Research Site
Rouen, , France
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Strasbourg, , France
Research Site
Toulouse, , France
Research Site
Tours, , France
Research Site
Villeurbanne, , France
Research Site
Bergamo, , Italy
Research Site
Brescia, , Italy
Research Site
Brescia, , Italy
Research Site
Florence, , Italy
Research Site
Genoa, , Italy
Research Site
Genoa, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Modena, , Italy
Research Site
Monza, , Italy
Research Site
Padua, , Italy
Research Site
Parma, , Italy
Research Site
Perugia, , Italy
Research Site
Pisa, , Italy
Research Site
Rome, , Italy
Research Site
Rome, , Italy
Countries
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Other Identifiers
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18F-AV-45-A18
Identifier Type: -
Identifier Source: org_study_id
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