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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01035164
First received: December 17, 2009
Last updated: November 25, 2013
Last verified: November 2013
  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:


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: 25
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 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Amsterdam, Netherlands, 1081 HV
Sweden
Stockholm, Sweden, 171 76
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
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: November 25, 2013
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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014