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

NCT01703702 | Completed Phase 4 Results

• 1 other identifier: 18F-AV-45-A18
• Study Type: interventional
• Target: 641
• Locations: 3 countries
• Sites: 57

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Clinical and Diagnostic Change in Patient Management

  Comparison of the percentage 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 and 3 months

• Change in ADAS-Cog 11 Total Score

  Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.

  Baseline and 12 months

Secondary Outcomes (5)

• Change in Patient's Clinical Diagnosis

  Baseline and 3 months

• Change in Diagnostic Confidence

  Baseline and 3 months

• Change in Patient Management: Advice/Counseling

  Baseline and 3 months

• Change in Caregiver Self-efficacy

  Baseline and 3 months

• Change in Patient Management: Individual Categories

  Baseline and 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.

Drug: florbetapir (18F)

Control

EXPERIMENTAL

Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

Drug: florbetapir (18F)

Interventions

florbetapir (18F) DRUG

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

Also known as: 18F-AV-45, florbetapir F 18, AV-45, Amyvid

Control; Intervention

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be enrolled in the mild impairment (not demented) group if the following criteria are met:
• Males or females ≥ 50 to \<= 90 years of age.
• Have cognitive decline verified by a study partner or cognitive impairment verified by the study physician.
• Have a study partner who provides separate consent and is willing to accompany the patient on all of the study visits.
• Have an MMSE score of 24 to 30 inclusive.
• Can tolerate a 10-minute PET scan.
• Have the ability to cooperate and comply with all study procedures.
• 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.
• Ability to provide informed consent for study procedures.
• Patients may be enrolled in the dementia group if the following criteria are met:
• Are males or females ≥ 50 to \<= 90 years of age.
• Meet clinical criteria for dementia.
• Have a caregiver who provides separate consent and is willing to accompany the patient on all of the study visits.
• Have an MMSE score of 16 to 24 inclusive.
• Have not received a clinical examination and/or laboratory test results that strongly indicates a non-neurodegenerative cause for the patients cognitive impairment.

You may not qualify if:

• Patients will be excluded from enrollment if they:
• Have a current serious or unstable illness;
• The patient or enrolling physician knows the result of a previous amyloid imaging scan;
• The patient has a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation;
• 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 (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;
• 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.
• Patients will also be excluded from enrollment if their 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 the management of their cognitive impairment.
• 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.
• 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.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead
• Eli Lilly and Company: collaborator

Study Sites (57)

Research Site

Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85054, United States

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Scottsdale, Arizona, 85258, United States

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Sun City, Arizona, 85351, United States

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Clearwater, Florida, 33756, United States

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Miami Beach, Florida, 33140, United States

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Orlando, Florida, 32806, United States

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West Palm Beach, Florida, 33407, United States

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Shreveport, Louisiana, 71130, United States

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Boston, Massachusetts, 02115, United States

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Chestnut Hill, Massachusetts, 02467, United States

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Quincy, Massachusetts, 02169, United States

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Las Vegas, Nevada, 89106, United States

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Las Vegas, Nevada, 89128, United States

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Patchogue, New York, 11772, United States

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Durham, North Carolina, 27710, United States

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Greensboro, North Carolina, 27405, United States

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Providence, Rhode Island, 02903, United States

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Providence, Rhode Island, 02906, United States

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Salt Lake City, Utah, 84108, United States

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Bennington, Vermont, 05201, United States

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Amiens, 80054, France

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Bordeaux, 33076, France

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Bron, 69500, France

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Dijon, 21033, France

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Lille, 59037, France

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Marseille, 13385, France

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Montpellier, 34000, France

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Nancy, 54035, France

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Nantes, 44093, France

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Nice, 06003, France

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Paris, 75651, France

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Pessac, 33604, France

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Reims, 51092, France

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Rouen, 76031, France

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Strasbourg, 67098, France

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Toulouse, 31059, France

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Tours, 37044, France

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Villeurbanne, 69100, France

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Bergamo, 24127, Italy

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Brescia, 20125, Italy

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Brescia, 25123, Italy

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Florence, 50139, Italy

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Genoa, 16128, Italy

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Genoa, 16132, Italy

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Milan, 20122, Italy

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Milan, 20132, Italy

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Milan, 20133, Italy

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Milan, 20162, Italy

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Modena, 41126, Italy

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Monza, 20900, Italy

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Padua, 35128, Italy

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Parma, 43100, Italy

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Perugia, 06132, Italy

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Pisa, 56126, Italy

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Rome, 00133, Italy

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Rome, 00179, Italy

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MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avid Radiopharmaceuticals

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 17, 2016
• Results First Posted: August 17, 2016

Record last verified: 2016-07

Locations

US (21); FR (18); IT (18)