Skip to main content

Florbetapir (18F) PET Imaging Effectiveness in Management of Patients with Cognitive Decline

  • Completed

The purpose of this Phase IV study is to determine the effectiveness of brain imaging with florbetapir (18F) in managing patients with cognitive decline and to evaluate the relationship between scan status and cognitive decline.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years Both No
October 2012
December 2014
600

All Participants

  • Study partner or caregiver who provides separate consent and is willing to accompany the patient on all study visits
  • Ability to tolerate 10-minute PET scan; ability to comply with all study procedures
  • Enrolling physician has less than high confidence in diagnosis of patient's cognitive condition at time of enrollment
  • Women of childbearing potential must be surgically sterile, refrain from sexual activity, or use reliable methods of contraception during the study.

Participants with Cognitive Decline

  • Cognitive decline verified by a study partner or cognitive impairment verified by the study physician
  • MMSE score of 24-30 inclusive

Participants with Dementia

  • Meet clinical criteria for dementia
  • MMSE score of 16-24 inclusive
  • Current serious or unstable illness
  • Participant or enrolling physician knows the result of a previous amyloid imaging scan
  • Known brain lesion, pathology, or alternative diagnosis that strongly explains the patient's clinical presentation
  • Taking investigational medications or have participated in a trial with investigational medications within the last 30 days
  • Past or current participation in an experimental study with an amyloid targeting agent (e.g., anti-amyloid immunotherapy, γ-secretase, β-secretase inhibitor) unless participant received only placebo
  • Have had radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
  • Enrolling physician:
    • Does not consider Alzheimer's disease as a potential cause of the patient's cognitive decline
    • Is not the primary physician taking care of the patient with respect to management of cognitive impairment
    • Cannot categorize the patient as either a) having a documented and completed evaluation for cognitive decline within the past 18 months or b) currently undergoing evaluation for cognitive decline
    • 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 of PET scan completion

None provided.

For information about this study or a participating study site, please contact Avid Clinical Operations at 215-298-0700 or clinicaloperations@avidrp.com.

 

Name City State Zip Status Primary Contact
Research Site Phoenix Arizona 85006 n/a

Research Site Phoenix Arizona 85054 n/a

Research Site Scottsdale Arizona 85258 n/a

Research Site Sun City Arizona 85351 n/a

Research Site Clearwater Florida 33756 n/a

Research Site Miami Beach Florida 33140 n/a

Research Site Orlando Florida 32806 n/a

Research Site West Palm Beach Florida 33407 n/a

Research Site Shreveport Louisiana 71130 n/a

Research Site Boston Massachusetts 02115 n/a

Research Site Chestnut Hill Massachusetts 02467 n/a

Research Site Quincy Massachusetts 02169 n/a

Research Site Las Vegas Nevada 89106 n/a

Research Site Las Vegas Nevada 89128 n/a

Research Site Patchogue New York 11772 n/a

Research Site Durham North Carolina 27710 n/a

Research Site Greensboro North Carolina 27405 n/a

Research Site Providence Rhode Island 02903 n/a

Research Site Providence Rhode Island 02906 n/a

Research Site Salt Lake City Utah 84108 n/a

Research Site Bennington Vermont 05201 n/a

Avid Radiopharmaceuticals

  • Eli Lilly and Company - Industry

Name Role Affiliation
Chief Medical Officer Study Director Avid Radiopharmaceuticals

Name Phone Extension Email
Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

A Randomized, Multicenter, Multicountry Study to Evaluate the Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and to Evaluate the Relationship Between Florbetapir (18F) PET Scan Status and Cognitive Decline