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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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01009359
First received: November 5, 2009
Last updated: July 30, 2013
Last verified: July 2013

November 5, 2009
July 30, 2013
October 2009
July 2010   (final data collection date for primary outcome 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 [ Time Frame: Day of Study tracer administration ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01009359 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: At least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum protein [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum creatinine [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum GOT (Glutamat-Oxalacetate-Transaminase) [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: Continuously and for a maximum of 28 days after end of observation phase ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: At least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum protein [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum creatinine [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Serum GOT (Glutamate-Oxalacetate-Transaminase) [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: Continuously and for a maximum of 28 days after end of observation phase ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diagnostic Imaging
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
October 2010
July 2010   (final data collection date for primary outcome measure)

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)
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Finland,   Netherlands
 
NCT01009359
13150, 2009-009358-26
No
Head Clinical Pharmacology, Bayer HealthCare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2013

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