Potential of Florbetapir F 18 PET to Inform Clinical Diagnosis and Management of Patients With Progressive Cognitive Decline

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01400425
First received: June 9, 2011
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Progressive Cognitive Decline
Drug: florbetapir F 18
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Potential of Florbetapir F 18 PET to Inform Clinical Diagnosis and Management of Patients With Progressive Cognitive Decline

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Negative Florbetapir F 18 PET Scan. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Positive Florbetapir F 18 PET Scan [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The impact of a positive 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 positive florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A positive florbetapir PET scan is indicative of moderate to frequent β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.

  • Change in Confidence of the Clinical Diagnosis [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in confidence of the clinical diagnosis prior to obtaining a florbetapir F 18 PET scan to the confidence after obtaining a florbetapir F 18 PET scan among subjects in whom the clinical diagnosis remains unchanged. Confidence levels were self-determined by physicians based on their diagnostic certainty and ranged from 0-100%. The mean (SD) change in confidence reflects the average change in diagnostic confidence along the 0-100% scale for the 62 subjects analyzed.

  • Change in Physician Management Plans [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Determine the percentage of subjects that had at least one hypothetical change between pre and post scan physician management plans. Change in management is defined as the number of subjects prescribed different item-wise plans at the two assessments divided by the total number of subjects in the population with both a pre and post florbetapir F 18 PET scan physician management plan.


Other Outcome Measures:
  • Item Wise Changes in Physician Management Plan [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    This outcome analyzed the percentage of subjects who had a hypothetical change in one of the medication or diagnostic categories listed below after receiving a florbetapir scan.

  • Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis After Obtaining a Florbetapir F 18 PET Scan. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The impact of a florbetapir F 18 PET scan on a physician's clinical diagnosis 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 florbetapir scan that led to a change in hypothetical clinical diagnosis is presented below.


Enrollment: 239
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects with Progressive Cognitive Decline
Subjects 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.
Drug: florbetapir F 18
IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are one of the following:

    1. Group A: Recently completed (within the past 18 months) a comprehensive clinical evaluation for progressive cognitive decline.
    2. Group B: Currently being evaluated for progressive cognitive decline with further clinical or laboratory testing still planned.
  • Have a site enrolling physician who has

    1. 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
    2. 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).

Exclusion Criteria:

  • 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.
  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: NCT01400425

Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85006
Research Site
Sun City, Arizona, United States, 85351
United States, California
Research Site
San Francisco, California, United States, 94109
United States, Colorado
Research Site
Boulder, Colorado, United States, 80304
United States, Florida
Research Site
Boynton Beach, Florida, United States, 33486
Research Site
Clearwater, Florida, United States, 33756
Research Site
Fort Myers, Florida, United States, 33912
Research Site
West Palm Beach, Florida, United States, 33407
United States, Louisiana
Research Site
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Research Site
Quincy, Massachusetts, United States, 02169
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89121
United States, New York
Research Site
New York, New York, United States, 10021
Research Site
Patchogue, New York, United States, 11772
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27705
Research Site
Greensboro, North Carolina, United States, 27401
United States, Rhode Island
Research Site
Providence, Rhode Island, United States, 02906
Research Site
Providence, Rhode Island, United States, 02903
United States, Texas
Research Site
Houston, Texas, United States, 77042
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: NCT01400425     History of Changes
Other Study ID Numbers: 18F-AV-45-A17
Study First Received: June 9, 2011
Results First Received: December 6, 2012
Last Updated: March 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014