Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703702
• Other study ID #: 18F-AV-45-A18
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2012
• Last updated: April 30, 2015
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Agence Nationale de Sécurité du Médicament et des produits de santéItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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, ? -secretase or ß -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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• florbetapir (18F)
Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Locations

Country	Name	City	State
France	Research Site	Amiens
France	Research Site	Bordeaux
France	Research Site	Bron
France	Research Site	Dijon
France	Research Site	Lille
France	Research Site	Marseille
France	Research Site	Montpellier
France	Research Site	Nancy
France	Research Site	Nantes
France	Research Site	Nice
France	Research Site	Paris
France	Research Site	Pessac
France	Research Site	Reims
France	Research Site	Rouen
France	Research Site	Strasbourg
France	Research Site	Toulouse
France	Research Site	Tours
France	Research Site	Villeurbanne
Italy	Research Site	Bergamo
Italy	Research Site	Brescia
Italy	Research Site	Brescia
Italy	Research Site	Florence
Italy	Research Site	Genoa
Italy	Research Site	Genoa
Italy	Research Site	Milan
Italy	Research Site	Milan
Italy	Research Site	Milan
Italy	Research Site	Milan
Italy	Research Site	Modena
Italy	Research Site	Monza
Italy	Research Site	Padova
Italy	Research Site	Parma
Italy	Research Site	Perugia
Italy	Research Site	Pisa
Italy	Research Site	Rome
Italy	Research Site	Rome
United States	Research Site	Bennington	Vermont
United States	Research Site	Boston	Massachusetts
United States	Research Site	Chestnut Hill	Massachusetts
United States	Research Site	Clearwater	Florida
United States	Research Site	Durham	North Carolina
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Miami Beach	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Patchogue	New York
United States	Research Site	Phoenix	Arizona
United States	Research Site	Phoenix	Arizona
United States	Research Site	Providence	Rhode Island
United States	Research Site	Providence	Rhode Island
United States	Research Site	Quincy	Massachusetts
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Sun City	Arizona
United States	Research Site	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Management	Comparison of the proportion of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).	baseline, 3 months and 12 months	No
Primary	Patient Prognosis	Association between scan status and cognitive decline.	baseline and 12 months	No
Secondary	Change in clinical diagnosis in patients for whom the scan results was not predicted by the initial diagnosis.	This objective will be to determine whether, at the 3 month time point, the scan information leads to (in the interventional arm compared to the control arm) a change in the clinical diagnosis in patients for whom the scan result was not predicted by the initial diagnosis. This measurement will compare the proportion of patients with scan results that were not predicted by the initial diagnosis and have a change in clinical diagnosis between the intervention and control arms	baseline and 3 months	No
Secondary	Change in treating physician's confidence in clinical diagnosis.	This objective will be to determine whether, at the 3 month time point, the scan information leads to (in the interventional arm compared to the control arm) a difference in the treating physician's confidence in clinical diagnosis. This will be measured by comparing the pre-scan confidence to the post-scan confidence among those patients with a scan result predicted by their baseline clinical diagnosis.	baseline and 3 months	No
Secondary	Change in patient and caregiver advice and counseling	This objective will be to determine whether, at the 3 month time point, the scan information leads to (in the interventional arm compared to the control arm) a difference in the percentage of patients who have a change in management relating to patient and caregiver advice and counseling.	baseline and 3 months	No
Secondary	Caregiver self-efficacy for managing dementia score.	This objective will be to determine whether, at the 3 month time point, the scan information leads to (in the interventional arm compared to the control arm) a difference in caregiver self-efficacy for managing dementia score (on the Fortinsky scale), adjusted for baseline self-efficacy.	baseline and 3 months	No