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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01035164
Other study ID # 91683
Secondary ID 2006-006045-1431
Status Completed
Phase Phase 1
First received December 17, 2009
Last updated January 7, 2015
Start date June 2007
Est. completion date January 2010

Study information

Verified date January 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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
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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Netherlands,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analysis/description of the uptake and description of brain PET scans Day of study tracer administration No
Primary 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 No
Secondary Standard quantification variables derived from 3D PET imaging and brain modeling Day of study tracer administration No
Secondary Standard Safety Measurement:adverse event collection Maximum time from Screening to Follow up are 37 days Yes
Secondary Standard Safety Measurement:electrocardiogram Maximum time from Screening to Follow up are 37 days Yes
Secondary Standard Safety Measurement:safety laboratory Maximum time from Screening to Follow up are 37 days Yes
Secondary Standard Safety Measurement: vital signs Maximum time from Screening to Follow up are 37 days Yes
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