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: August 13, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 5, 2009

Last Updated Date

August 13, 2012

Start Date ^ICMJE

October 2009

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01009359 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

October 2010

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)

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01009359

Other Study ID Numbers ^ICMJE

13150, 2009-009358-26

Has Data Monitoring Committee

Responsible Party

Head Clinical Pharmacology, Bayer HealthCare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

August 2012

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

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