Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01138111
First received: April 1, 2010
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.


Condition Intervention Phase
Alzheimer Disease
Amyloid Beta-Protein
Drug: Florbetaben (BAY94-9172)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ß-amyloid Imaging With BAY94-9172 Positron Emission Tomography for Early Detection of Alzheimer's Disease in Patients With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake [ Time Frame: 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months ] [ Designated as safety issue: No ]
    Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)


Secondary Outcome Measures:
  • Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4 [ Time Frame: 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months ] [ Designated as safety issue: No ]
    This outcome measure showed the number of abnormal scans in subjects with MCI progressing to AD and those who did not progress compared to subjects with normal scans that did not progress and those who did progress.

  • Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress [ Time Frame: 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months ] [ Designated as safety issue: No ]
    At each study time point (baseline, 12 months and 24 months) PET images were obtained at 45 min and again at 90 post injection. These images were assigned a BAPL score of 1, 2 or 3 based on the reader's evaluation of the scan. A BAPL scores of 1 was considered normal, and scores of 2 and 3 were considered abnormal. These scores were compared to subjects clinical diagnosis for AD at the end of the study follow up period.

  • Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress [ Time Frame: 2 scanning periods post injection to be evaluated at baseline ] [ Designated as safety issue: No ]

    Sensitivity, specificity, NPV and PPV were measured based on subject BAPL scores by time point and imaging window, compared to clinical diagnosis of AD during the study period. A BAPL score of 1 was considered negative for the presence of beta-amyloid, and scores of 2 and 3 were considered positive.

    For this study, sensitivity was defined as the percentage of subjects with a clinical diagnosis of AD who also had a positive PET scan (BAPL score of 2 or 3) at the respective time point.

    Specificity was defined as the percentage of subjects with a clinical diagnosis of non-AD who also had a negative PET scan (BAPL score of 0 or 1) at the respective time point.

    PPV was defined as the probability that a subject with a positive PET scan would have a clinical diagnosis of AD sometime during the 2 year follow up period.

    NPV was defined as the probability that a subject with a negative PET scan would not have a clinical diagnosis of AD at any point during the 2 year follow up period.



Enrollment: 45
Study Start Date: June 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Florbetaben (BAY94-9172)
single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of MCI defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss.
  • Absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years.
  • Able to give written informed consent.
  • Age >/= 60 years of age
  • >/= 7 years of education

Exclusion Criteria:

  • Mini mental state examination (MMSE) score < 24 at baseline
  • Clinical dementia rating (CDR) score > 0.5 at baseline
  • Patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics)
  • Existing or history of cancer
  • History of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion
  • Lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder
  • Contraindications to MRI (Magnetic resonance imaging)
  • Relevant history, physical or imaging findings of neurological disease other than MCI and mild depression
  • History of severe anaphylactic reaction or high risk of allergic reaction to drugs
  • Patient has received another investigational drug in the preceding 14 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138111

Locations
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Piramal Imaging SA
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01138111     History of Changes
Other Study ID Numbers: 312043
Study First Received: April 1, 2010
Results First Received: January 10, 2014
Last Updated: May 22, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Piramal Imaging SA:
Florbetaben
Amyloid beta-protein
MCI
Alzheimer's disease

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

ClinicalTrials.gov processed this record on October 20, 2014