ß-amyloid Imaging With BAY94-9172 Positron Emission Tomography for Early Detection of Alzheimer's Disease in Patients With Mild Cognitive Impairment

Life Molecular Imaging SA0 sites45 target enrollmentJune 2008

ConditionsAlzheimer Disease Amyloid Beta-Protein

InterventionsFlorbetaben (BAY94-9172)

DrugsFlorbetaben (BAY94-9172)

Overview

Phase: Phase 1
Intervention: Florbetaben (BAY94-9172)
Conditions: Alzheimer Disease
Sponsor: Life Molecular Imaging SA
Enrollment: 45
Primary Endpoint: Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

December 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Life Molecular Imaging SA

Responsible Party

Sponsor

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

Arms & Interventions

Arm 1

Intervention: Florbetaben (BAY94-9172)

Outcomes

Primary Outcomes

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

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 Outcomes

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(2 scanning periods post injection to be evaluated at baseline)
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(1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months)
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(2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months)