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

Phase 1

Completed

• Conditions: Positron-Emission Tomography; Alzheimer's Disease
• Interventions: Drug: F-18 FEDAA1106 (BAY85-8101)

• Registration Number: NCT01035164
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	F-18 FEDAA1106 (BAY85-8101)	-
Arm 2	F-18 FEDAA1106 (BAY85-8101)	-
Arm 3	F-18 FEDAA1106 (BAY85-8101)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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: vital signs	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