Skip to main content
OpenTrials
Completed

NCT Number: NCT01035164

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

F-18 FEDAA1106 (BAY85-8101)

Drug

Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET

Primary outcomes

  1. Visual analysis/description of the uptake and description of brain PET scans

    Time frame: Day of study tracer administration

  2. 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

Secondary outcomes

  1. Standard quantification variables derived from 3D PET imaging and brain modeling

    Time frame: Day of study tracer administration

  2. Standard Safety Measurement:adverse event collection

    Time frame: Maximum time from Screening to Follow up are 37 days

  3. Standard Safety Measurement:electrocardiogram

    Time frame: Maximum time from Screening to Follow up are 37 days

  4. Standard Safety Measurement:safety laboratory

    Time frame: Maximum time from Screening to Follow up are 37 days

  5. Standard Safety Measurement: vital signs

    Time frame: Maximum time from Screening to Follow up are 37 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 18, 2009
Registry last updated
Jan 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.