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

Purpose

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

Condition	Intervention	Phase
Positron-Emission Tomography Alzheimer's Disease	Drug: F-18 FEDAA1106 (BAY85-8101)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Visual analysis/description of the uptake and description of brain PET scans [ Time Frame: Day of study tracer administration ] [ Designated as safety issue: No ]
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. [ Time Frame: Day of study tracer administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Standard quantification variables derived from 3D PET imaging and brain modeling [ Time Frame: Day of study tracer administration ] [ Designated as safety issue: No ]
Standard Safety Measurement:adverse event collection [ Time Frame: Maximum time from Screening to Follow up are 37 days ] [ Designated as safety issue: Yes ]
Standard Safety Measurement:electrocardiogram [ Time Frame: Maximum time from Screening to Follow up are 37 days ] [ Designated as safety issue: Yes ]
Standard Safety Measurement:safety laboratory [ Time Frame: Maximum time from Screening to Follow up are 37 days ] [ Designated as safety issue: Yes ]
Standard Safety Measurement: vital signs [ Time Frame: Maximum time from Screening to Follow up are 37 days ] [ Designated as safety issue: Yes ]

Enrollment:	54
Study Start Date:	June 2007
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: F-18 FEDAA1106 (BAY85-8101) Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
Experimental: Arm 2	Drug: F-18 FEDAA1106 (BAY85-8101) Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
Experimental: Arm 3	Drug: F-18 FEDAA1106 (BAY85-8101) 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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 years

Healthy 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035164

Locations

Netherlands

Amsterdam, Netherlands, 1081 HV
Sweden

Stockholm, Sweden, 171 76

Stockholm, Sweden, 14186

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT01035164 History of Changes
Other Study ID Numbers:	91683, EudraCT: 2006-006045-14, 311401
Study First Received:	December 17, 2009
Last Updated:	February 4, 2010
Health Authority:	Sweden: Medical Products Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bayer:

Alzheimer's Disease
Diagnostic Imaging
Neuroinflammation
PET Diagnosis
PET Tracer

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013