NCT01009359CompletedPhase 1
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 22
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Arm 1
Experimental
Intervention: F-18 DPA-714 (BAY85-8102) (Drug)
Arm 2
Experimental
Intervention: F-18 DPA-714 (BAY85-8102) (Drug)
Arm 3
Experimental
Intervention: F-18 DPA-714 (BAY85-8102) (Drug)
Outcomes
Primary Outcomes
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
Time Frame: Day of Study tracer administration
Secondary Outcomes
- 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)(Day of Study tracer administration)
- Electrocardiogram (ECG)(At least once within 8 days after treatment)
- Blood pressure(At least 2 times within 8 days after treatment)
- Serum protein(At least once within 8 days after treatment)
- Serum creatinine(At least once within 8 days after treatment)
- Serum GOT (Glutamat-Oxalacetate-Transaminase)(At least once within 8 days after treatment)
- Adverse events collection(Continuously and for a maximum of 28 days after end of observation phase)
Investigators
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