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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diagnostic Imaging	Drug: F-18 DPA-714 (BAY85-8102)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
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.

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Bayer:

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 [ Time Frame: Day of Study tracer administration ] [ Designated as safety issue: No ]

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) [ 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 ]

Enrollment:	22
Study Start Date:	October 2009
Study Completion Date:	October 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	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
Experimental: Arm 2	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
Experimental: Arm 3	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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009359

Locations

Finland

Turku, Finland, 20520
Netherlands

Amsterdam, Netherlands, 1081 HV

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT01009359 History of Changes
Other Study ID Numbers:	13150, 2009-009358-26
Study First Received:	November 5, 2009
Last Updated:	August 13, 2012
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Finland: Finnish Medicines Agency

Keywords provided by Bayer:

Alzheimers disease
Diagnostic imaging
PET/CT diagnosis
PET tracer

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013