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

Phase 1

Completed

• Conditions: Diagnostic Imaging
• Interventions: Drug: F-18 DPA-714 (BAY85-8102)

• Registration Number: NCT01009359
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Primary Completion: 2010-07
• Study Completion: 2010-10
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	F-18 DPA-714 (BAY85-8102)	-
Arm 2	F-18 DPA-714 (BAY85-8102)	-
Arm 3	F-18 DPA-714 (BAY85-8102)	-

Primary Outcome Measures

Name	Time	Method
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	Day of Study tracer administration

Secondary Outcome Measures

Name	Time	Method
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
Blood pressure	At least 2 times within 8 days after treatment
Serum protein	At least once within 8 days after treatment
Electrocardiogram (ECG)	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