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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: July 30, 2013
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 August 28, 2014