Alzheimer's Disease Education and Referral Center

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

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

Overall Status: 
Active, not recruiting
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
90 Years
Both
No
Inclusion Criteria: 

    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
Exclusion Criteria: 
    • 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
Detailed Description: 

None provided.

Central Contact Information: 

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

 

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Name:
Phone:

Geolocation is 33.6923299, -111.9403254

Site
Phoenix
Arizona
85054
Name:
Phone:

Geolocation is 33.5669912, -111.8985922

Site
Scottsdale
Arizona
85258
Name:
Phone:

Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Name:
Phone:

Geolocation is 27.9413341, -82.7940297

Site
Clearwater
Florida
33756
Name:
Phone:

Geolocation is 25.8176795, -80.1372757

Site
Miami Beach
Florida
33140
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Name:
Phone:

Geolocation is 32.49, -93.77

Site
Shreveport
Louisiana
71130
Name:
Phone:

Geolocation is 42.339904, -71.0898892

Site
Boston
Massachusetts
02115
Name:
Phone:

Geolocation is 42.3303798, -71.166187

Site
Chestnut Hill
Massachusetts
02467
Name:
Phone:

Geolocation is 42.2513682, -70.9962875

Site
Quincy
Massachusetts
02169
Name:
Phone:

Geolocation is 36.1988542, -115.2659777

Site
Las Vegas
Nevada
89128
Name:
Phone:

Geolocation is 36.1922841, -115.1592718

Site
Las Vegas
Nevada
89106
Name:
Phone:

Geolocation is 40.7656538, -73.0151084

Site
Patchogue
New York
11772
Name:
Phone:

Geolocation is 36.0038131, -78.9387241

Site
Durham
North Carolina
27710
Name:
Phone:

Geolocation is 36.1155274, -79.7512033

Site
Greensboro
North Carolina
27405
Name:
Phone:

Geolocation is 41.8396817, -71.3883751

Site
Providence
Rhode Island
02906
Name:
Phone:

Geolocation is 41.816736, -71.4091563

Site
Providence
Rhode Island
02903
Name:
Phone:

Geolocation is 40.7834328, -111.7376178

Site
Salt Lake City
Utah
84108
Name:
Phone:

Geolocation is 42.878094, -73.1968001

Site
Bennington
Vermont
05201
Name:
Phone:
Lead Sponsor: 
Agency
Avid Radiopharmaceuticals
Collaborator Sponsor: 
Agency
Eli Lilly and Company
Facility Investigators: 
NameRoleAffiliation
Chief Medical Officer
Study Director
Avid Radiopharmaceuticals
Study Contact: 
NamePhoneEmail
Avid Clinical Operations
215-298-0700
Locations
 
 
ClinicalTrials.gov ID 
NCT01703702 (follow link to view full record on ct.gov in new window)
Official Title: 
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
Study Start Date: 
October 2012
Study End Date: 
December 2014
Disease Stage: 
Pre-clinical
Early
Middle
Enrollment: 
600