Trial Condition(s):

Positron-Emission Tomography, Alzheimer's Disease

Evaluation of ZK 6032924 in probable Alzheimer's disease patients versus healthy volunteers and the radiation dosimetry of ZK 6032924 in healthy volunteers

Bayer Identifier:

91683

ClinicalTrials.gov Identifier:

NCT01035164

EudraCT Number:

2006-006045-14

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
25
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
F18-FEDAA1106 (BAY85-8101)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden, 141 86

Status
Completed
 
Locations

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands, 1081 HV

Status
Completed
 

Trial Design