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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

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ClinicalTrials.gov Identifier: NCT01009359
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : July 31, 2013
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 6, 2009
Last Update Posted Date July 31, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
Discrimination of probable Alzheimer 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • 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) [ Time Frame: Day of Study tracer administration ]
  • Electrocardiogram (ECG) [ Time Frame: At least once within 8 days after treatment ]
  • Blood pressure [ Time Frame: At least 2 times within 8 days after treatment ]
  • Serum protein [ Time Frame: At least once within 8 days after treatment ]
  • Serum creatinine [ Time Frame: At least once within 8 days after treatment ]
  • Serum GOT (Glutamat-Oxalacetate-Transaminase) [ Time Frame: At least once within 8 days after treatment ]
  • Adverse events collection [ Time Frame: Continuously and for a maximum of 28 days after end of observation phase ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
  • Discrimination of probable Alzheimer 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) [ Time Frame: Day of Study tracer administration ]
  • Electrocardiogram (ECG) [ Time Frame: At least once within 8 days after treatment ]
  • Blood pressure [ Time Frame: At least 2 times within 8 days after treatment ]
  • Serum protein [ Time Frame: At least once within 8 days after treatment ]
  • Serum creatinine [ Time Frame: At least once within 8 days after treatment ]
  • Serum GOT (Glutamate-Oxalacetate-Transaminase) [ Time Frame: At least once within 8 days after treatment ]
  • Adverse events collection [ Time Frame: Continuously and for a maximum of 28 days after end of observation phase ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Diagnostic Imaging
Intervention  ICMJE
  • Drug: F-18 DPA-714 (BAY85-8102)
    Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
  • Drug: F-18 DPA-714 (BAY85-8102)
    Healthy volunteers for brain imaging: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
  • Drug: F-18 DPA-714 (BAY85-8102)
    Healthy volunteers for whole body imaging: Single intervenous bolus injection of 150 MBq BAY85-8102, whole body PET/CT for evaluation of effective dose, kinetics of BAY85-8102 in blood
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: F-18 DPA-714 (BAY85-8102)
  • Experimental: Arm 2
    Intervention: Drug: F-18 DPA-714 (BAY85-8102)
  • Experimental: Arm 3
    Intervention: Drug: F-18 DPA-714 (BAY85-8102)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2010)
22
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2009)
40
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01009359
Other Study ID Numbers  ICMJE 13150
2009-009358-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Head Clinical Pharmacology, Bayer HealthCare AG
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP