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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01703702
First received: October 5, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: florbetapir (18F)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Patient Management [ Time Frame: baseline, 3 months and 12 months ] [ Designated as safety issue: No ]
    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).

  • Patient Prognosis [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Association between scan status and cognitive decline.


Secondary Outcome Measures:
  • Change in clinical diagnosis in patients for whom the scan results was not predicted by the initial diagnosis. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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

  • Change in treating physician's confidence in clinical diagnosis. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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.

  • Change in patient and caregiver advice and counseling [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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.

  • Caregiver self-efficacy for managing dementia score. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
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
Other Names:
  • 18F-AV-45
  • florbetapir F 18
  • AV-45
  • Amyvid
Experimental: Control
Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
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
Other Names:
  • 18F-AV-45
  • florbetapir F 18
  • AV-45
  • Amyvid

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703702

  Show 52 Study Locations
Sponsors and Collaborators
Avid Radiopharmaceuticals
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01703702     History of Changes
Other Study ID Numbers: 18F-AV-45-A18
Study First Received: October 5, 2012
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014