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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

Primary Purpose

Diagnostic Imaging

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
F-18 DPA-714 (BAY85-8102)
F-18 DPA-714 (BAY85-8102)
F-18 DPA-714 (BAY85-8102)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnostic Imaging focused on measuring Alzheimers disease, Diagnostic imaging, PET/CT diagnosis, PET tracer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Electrocardiogram (ECG)
Blood pressure
Serum protein
Serum creatinine
Serum GOT (Glutamat-Oxalacetate-Transaminase)
Adverse events collection

Full Information

First Posted
November 5, 2009
Last Updated
July 30, 2013
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01009359
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnostic Imaging
Keywords
Alzheimers disease, Diagnostic imaging, PET/CT diagnosis, PET tracer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
F-18 DPA-714 (BAY85-8102)
Intervention Description
Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
Intervention Type
Drug
Intervention Name(s)
F-18 DPA-714 (BAY85-8102)
Intervention Description
Healthy volunteers for brain imaging: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
Intervention Type
Drug
Intervention Name(s)
F-18 DPA-714 (BAY85-8102)
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Electrocardiogram (ECG)
Time Frame
At least once within 8 days after treatment
Title
Blood pressure
Time Frame
At least 2 times within 8 days after treatment
Title
Serum protein
Time Frame
At least once within 8 days after treatment
Title
Serum creatinine
Time Frame
At least once within 8 days after treatment
Title
Serum GOT (Glutamat-Oxalacetate-Transaminase)
Time Frame
At least once within 8 days after treatment
Title
Adverse events collection
Time Frame
Continuously and for a maximum of 28 days after end of observation phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Turku
ZIP/Postal Code
20520
Country
Finland
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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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