Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers

Study Overview
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Brief Summary
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PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.

Official Title
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Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq (6.75 mCi) ZK 6032924 (18F-FEDAA1106) for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimer's Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of 185 MBq (5 mCi) ZK 6032924 in Healthy Volunteers.

Conditions
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Positron-Emission Tomography, Alzheimer's Disease

Intervention / Treatment
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* Drug: F-18 FEDAA1106 (BAY85-8101)
* Drug: F-18 FEDAA1106 (BAY85-8101)
* Drug: F-18 FEDAA1106 (BAY85-8101)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Patients for brain imaging:- patient and designee capable of giving fully informed consent in writing- patient fulfils DSM-IV and NINCDS-ADRDA criteria for probable Alzheimer's disease. Other forms of dementia excluded- males or postmenopausal females aged >/= 50 yearsHealthy volunteers for brain imaging: - able to give fully informed consent in writing- absence of any sign of dementia/cognitive impairment in neuropsychological examinations- males or postmenopausal females aged >/= 50 years Healthy volunteers for whole body imaging:- able to give fully informed consent in writing - males or postmenopausal females aged >/= 60 years - no significant disease or drug use Exclusion Criteria:For all healthy volunteers and patients:- Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: F-18 FEDAA1106 (BAY85-8101)<br>* Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET<br>|
| Experimental: Arm 2<br> | Drug: F-18 FEDAA1106 (BAY85-8101)<br>* Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET<br>|
| Experimental: Arm 3<br> | Drug: F-18 FEDAA1106 (BAY85-8101)<br>* Healthy volunteers for whole body imaging: Single intravenous bolus injection of 185 MBq BAY85-8101, whole body PET for evaluation of effective dose, kinetics of BAY85-8101 in blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analysis/description of the uptake and description of brain PET scans |  | Day of study tracer administration | 
| Standardized uptake value (SUV) in various cerebral regions/volumes of interest (ROI/VOI) assumed and found to be involved in the pathophysiology of Alzheimer's disease. |  | Day of study tracer administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard quantification variables derived from 3D PET imaging and brain modeling |  | Day of study tracer administration | 
| Standard Safety Measurement:adverse event collection |  | Maximum time from Screening to Follow up are 37 days | 
| Standard Safety Measurement:electrocardiogram |  | Maximum time from Screening to Follow up are 37 days | 
| Standard Safety Measurement:safety laboratory |  | Maximum time from Screening to Follow up are 37 days | 
| Standard Safety Measurement: vital signs |  | Maximum time from Screening to Follow up are 37 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, Diagnostic Imaging, Neuroinflammation, PET Diagnosis, PET Tracer