An open-label, non-randomized study to evaluate the efficacy and safety of BAY 94-9172 (ZK 6013443) positron emission tomography (PET) imaging for detection/exclusion of cerebral ß-amyloid when compared to postmortem histopathology - Safety and efficacy of positron emission tomography imaging with BAY 94-9172 (ZK 6013443)

Bayer HealthCare AG0 sites218 target enrollmentOctober 9, 2009

ConditionsDetection/Exclusion of cerebral ß-amyloid.To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth.MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Detection/Exclusion of cerebral ß-amyloid.To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth.
Sponsor: Bayer HealthCare AG
Enrollment: 218
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 9, 2009

End Date

December 24, 2013

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bayer HealthCare AG

Eligibility Criteria

Inclusion Criteria

•Subjects with a low probability of cerebral ß\-amyloid deposition, e.g. non\-demented volunteers and subjects with a high probability of ß\-amyloid deposition, e.g.patients diagnosed with AD or Dementia with Lewy Bodies (DLB), 10 cognitively normal and young healthy volunteers between 21 and 40 years of age.
•Each study participant has to meet the following criteria:
•\- is at least 21 years of age
•\- females, no child\-bearing potential of negative urine pregnancy test on day of BAY 94\-9172 injection
•\- exhibits visual, auditory, and communicative capabilities adequate to provide informed consent or assent and comply with study procedures
•\- is willing and able to lie down in MRI and PET scanners
•\- is willing to donate their brain for postmortem examination in case of death (not required of the healthy volunteers)
•\- the subject or the subject and/or legally acceptable representative will be compliant and have a high probability of completing the study in the opinion of the investigator
•\- has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability, as applicable, and informed consent or assent has been signed and dated by the subject and/or the subject's legally acceptable representative
•Are the trial subjects under 18? no

Exclusion Criteria

•Each subject who meets any of the following criteria must not participate in this study:
•\- has signs of major cerebrovascular disease as verified by medical history, e.g. fulfills the operational definitions of imaging guidelines of the NINDS\-AIREN criteria for vascular dementia and by magnetic resonance brain imaging, e.g. an ARWMC score of \> 2
•\- has any contraindication to magnetic resonance imaging examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
•\- is scheduled for surgery and/or another invasive procedure within the time period of up to 7 days following study drug administration
•\- is allergic to the study drug or any of its constituents
•\- has received any contrast material (X\-ray, MRI) or radiopharmaceutical within 48 hours prior to or a therapeutic radiopharmaceutical (e.g. 131I) within 10 days prior to the administration of the study drug or for whom administration of such substances is planned within 7 days following study drug administration
•\- has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half\-lives to study drug administration in this study
•\- is medically unstable and whose clinical course during the observation period is unpredicatable as determined by the onsite investigator, e.g. patients/volunteers with acute myocardial infarction, stroke or renal failure.