Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers

Bayer

Status and phase

Completed

Phase 1

Conditions

Multiple Sclerosis

Positron-Emission Tomography

Treatments

Drug: F-18 FEDAA1106 (BAY85-8101)

Study type

Interventional

Funder types

Industry

Identifiers

13101

2008-000981-22 (EudraCT Number)

Details and patient eligibility

About

PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers

Enrollment

16 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteers for brain imaging:

males or females, age 20 - 55 years
assessment of the brain MRI as "normal (age-appropriate)"
absence of any sign of CNS disease, no co-medi cation Patients for brain imaging
males or females, age 20 - 55 years
patients with previously diagnosed MS, presenting with acute relapse, without any current immunomodulating therapy for MS ("drug-naïve"), or patients presenting with first clinical episode suggestive of demyelinating disease (Clinically Isolated Syndrome, CIS)
patients with previously diagnosed MS, presenting with acute relapse, receiving currently immunomodulatory therapy exclusively with interferon β
MRI: >/= 2 T2 lesions and >/= 1 Gadolinium- (Gd-) enhancing lesion

Exclusion criteria

Exclusion criteria for all healthy volunteers and patients:

Pregnancy or lactation
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
other forms of diseases with neuroinflammatory components