Clinical trial NCT01009359: 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
Official title: Open-label, Non-randomized, Multicenter Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq BAY85-8102 F-18, DPA-714 for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimers Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of 150 MBq BAY858102 F-18, DPA-714 in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diagnostic Imaging
Keywords: Alzheimers disease
Diagnostic imaging
PET/CT diagnosis
PET tracer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approaches
timeFrame: Day of Study tracer administration
Secondary outcomes:
measure: Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by visual analysis and standard parameters(e.g. Standardized Uptake Values = SUV)
timeFrame: Day of Study tracer administration
measure: Electrocardiogram (ECG)
timeFrame: At least once within 8 days after treatment
measure: Blood pressure
timeFrame: At least 2 times within 8 days after treatment
measure: Serum protein
timeFrame: At least once within 8 days after treatment
measure: Serum creatinine
timeFrame: At least once within 8 days after treatment
measure: Serum GOT (Glutamat-Oxalacetate-Transaminase)
timeFrame: At least once within 8 days after treatment
measure: Adverse events collection
timeFrame: Continuously and for a maximum of 28 days after end of observation phase
Other outcomes:
Locations:
city: Turku
country: Finland
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: