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

Primary Purpose

Alzheimer Disease, Amyloid Beta-Protein

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Florbetaben (BAY94-9172)
Sponsored by
Life Molecular Imaging SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Florbetaben, Amyloid beta-protein, MCI, Alzheimer's disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
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
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
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
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.

Full Information

First Posted
April 1, 2010
Last Updated
May 22, 2014
Sponsor
Life Molecular Imaging SA
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1. Study Identification

Unique Protocol Identification Number
NCT01138111
Brief Title
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients
Official Title
ß-amyloid Imaging With BAY94-9172 Positron Emission Tomography for Early Detection of Alzheimer's Disease in Patients With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life Molecular Imaging SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Amyloid Beta-Protein
Keywords
Florbetaben, Amyloid beta-protein, MCI, Alzheimer's disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Florbetaben (BAY94-9172)
Intervention Description
single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
Primary Outcome Measure Information:
Title
Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
Description
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)
Time Frame
1 scanning period post injection to be evaluated at baseline, 12 months and 24 months
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months
Title
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
Description
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.
Time Frame
2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months
Title
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
Description
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.
Time Frame
2 scanning periods post injection to be evaluated at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
33773598
Citation
Bullich S, Roe-Vellve N, Marquie M, Landau SM, Barthel H, Villemagne VL, Sanabria A, Tartari JP, Sotolongo-Grau O, Dore V, Koglin N, Muller A, Perrotin A, Jovalekic A, De Santi S, Tarraga L, Stephens AW, Rowe CC, Sabri O, Seibyl JP, Boada M. Early detection of amyloid load using 18F-florbetaben PET. Alzheimers Res Ther. 2021 Mar 27;13(1):67. doi: 10.1186/s13195-021-00807-6.
Results Reference
derived
PubMed Identifier
24970906
Citation
Ong KT, Villemagne VL, Bahar-Fuchs A, Lamb F, Langdon N, Catafau AM, Stephens AW, Seibyl J, Dinkelborg LM, Reininger CB, Putz B, Rohde B, Masters CL, Rowe CC. Abeta imaging with 18F-florbetaben in prodromal Alzheimer's disease: a prospective outcome study. J Neurol Neurosurg Psychiatry. 2015 Apr;86(4):431-6. doi: 10.1136/jnnp-2014-308094. Epub 2014 Jun 26.
Results Reference
derived

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

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