Potential of Florbetapir F 18 PET to Inform Clinical Diagnosis and Management of Patients With Progressive Cognitive Decline
1 other identifier
interventional
239
1 country
18
Brief Summary
The study is designed to evaluate whether a florbetapir F 18 PET scan can impact clinical thinking when physicians are determining the likely cause of a subject's cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2011
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
March 22, 2013
CompletedMarch 29, 2013
March 1, 2013
1 year
June 9, 2011
December 6, 2012
March 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Negative Florbetapir F 18 PET Scan.
The impact of a negative florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a negative florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A negative florbetapir PET scan is indicative of none to sparse β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.
6 weeks
Secondary Outcomes (3)
Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Positive Florbetapir F 18 PET Scan
6 weeks
Change in Confidence of the Clinical Diagnosis
6 weeks
Change in Physician Management Plans
6 weeks
Other Outcomes (2)
Item Wise Changes in Physician Management Plan
6 weeks
Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis After Obtaining a Florbetapir F 18 PET Scan.
6 weeks
Study Arms (1)
Subjects with Progressive Cognitive Decline
EXPERIMENTALSubjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan.
Interventions
IV injection, 370 megabecquerel (MBq) (10 millicurie \[mCi\]), single dose
Eligibility Criteria
You may qualify if:
- Are one of the following:
- Group A: Recently completed (within the past 18 months) a comprehensive clinical evaluation for progressive cognitive decline.
- Group B: Currently being evaluated for progressive cognitive decline with further clinical or laboratory testing still planned.
- Have a site enrolling physician who has
- less than high confidence in their diagnosis for the subject related to the cognitive decline at the time of enrollment. The level of confidence in the diagnosis should be rated by the physician as less than 85%, and should be interpreted as the physician estimating that their diagnosis will be correct in less than 85% of patients with the same presentation as the subject; and
- suspicion that the subject's cognitive decline is caused, at least in part, by Alzheimer's disease. The level of suspicion should be rated by the physician as there being at least 15% of patients with the same presentation as the subject would have Alzheimer's disease;
- Can tolerate a 10 minute PET scan. The Principal Investigator will carefully assess each subject and use sound medical judgment to determine whether the subject can tolerate the PET scan procedure;
- Have the ability to cooperate and comply with all study procedures;
- Have a study partner willing to accompany the subject on all of the study visits; and
- Give informed consent for study procedures (If the subject is incapable of giving informed consent, the subject's designated decision maker may consent on behalf of the subject but the subject must still confirm assent. This person may serve as the study partner as well).
You may not qualify if:
- Subject or site enrolling physician knows the result of a previous amyloid imaging scan.
- Are considered medically unstable;
- Require additional laboratory tests or workup between enrollment and completion of the florbetapir F 18 PET scan;
- Have a clinically significant infectious disease, including Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection;
- Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
- Have ever participated in an experimental study with an amyloid targeting agent unless it can be documented that the subject received only placebo during the course of the trial;
- Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum β-hCG at the time of screening and negative urine β-hCG on the day of imaging) or breast feeding at screening. Females must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or intrauterine device (IUD) for 24 hours following administration of florbetapir F 18.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Research Site
Phoenix, Arizona, 85006, United States
Research Site
Sun City, Arizona, 85351, United States
Research Site
San Francisco, California, 94109, United States
Research Site
Boulder, Colorado, 80304, United States
Research Site
Boynton Beach, Florida, 33486, United States
Research Site
Clearwater, Florida, 33756, United States
Research Site
Fort Myers, Florida, 33912, United States
Research Site
West Palm Beach, Florida, 33407, United States
Research Site
Shreveport, Louisiana, 71130, United States
Research Site
Quincy, Massachusetts, 02169, United States
Research Site
Las Vegas, Nevada, 89121, United States
Research Site
New York, New York, 10021, United States
Research Site
Patchogue, New York, 11772, United States
Research Site
Durham, North Carolina, 27705, United States
Research Site
Greensboro, North Carolina, 27401, United States
Research Site
Providence, Rhode Island, 02903, United States
Research Site
Providence, Rhode Island, 02906, United States
Research Site
Houston, Texas, 77042, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Avid Radiopharmaceuticals
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Avid Radiopharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
July 22, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
March 29, 2013
Results First Posted
March 22, 2013
Record last verified: 2013-03