Clinical trial NCT01703702: Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2012-10-10
Enrollment: 641
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.


Eligibility criteria: Inclusion Criteria:

Patients may be enrolled in the mild impairment (not demented) group if the following criteria are met:

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:

Patients will be excluded from enrollment if they:

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.

Primary outcomes:
measure: Clinical and Diagnostic Change in Patient Management
timeFrame: Baseline and 3 months
measure: Change in ADAS-Cog 11 Total Score
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Patient's Clinical Diagnosis
timeFrame: Baseline and 3 months
measure: Change in Diagnostic Confidence
timeFrame: Baseline and 3 months
measure: Change in Patient Management: Advice/Counseling
timeFrame: Baseline and 3 months
measure: Change in Caregiver Self-efficacy
timeFrame: Baseline and 3 months
measure: Change in Patient Management: Individual Categories
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Sun City
country: United States
facility: Research Site
state: Arizona
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Miami Beach
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Research Site
state: Massachusetts
city: Quincy
country: United States
facility: Research Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Patchogue
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Bennington
country: United States
facility: Research Site
state: Vermont
city: Amiens
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Bron
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Villeurbanne
country: France
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Florence
country: Italy
facility: Research Site
city: Genoa
country: Italy
facility: Research Site
city: Genoa
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Monza
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: