Trial Condition(s):

Diagnostic Imaging

Evaluation of the neuroinflammation pattern of BAY85-8102 F-18, DPA-714 in probable Alzheimers disease patients versus healthy volunteers and radiation dosimetry of F 18, DPA-714 in healthy volunteers

Bayer Identifier:

13150

ClinicalTrials.gov Identifier:

NCT01009359

EudraCT Number:

2009-009358-26

Study Completed

Trial Purpose

PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer.

Inclusion Criteria
- Able to give fully informed consent in writing
 - Males or females aged >/= 50 years  
 - No significant disease or drug use 
 - Absence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging: 
 - Patient and designee capable of giving fully informed consent in writing 
 - Patient fulfils DSM-IV and NINCDS-ADRA criteria for probable Alzheimers disease 
  - Patient has undergone physical and neurological examination, ECG and test of routine hematological and biochemical parameters prior to radiotracer administration
Exclusion Criteria
- Pregnancy or lactation
 - Current unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection)

Trial Summary

Enrollment Goal
22
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
F18 DPA-714 (BAY85-8102)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands, 1081 HV

Status
Completed
 
Locations

Clinical Research Services Turku

Turku, Finland, 20520

Status
Completed
 

Trial Design