Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01153607
First received: April 23, 2010
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic potential in probable Alzheimer Disease patients versus healthy volunteers and radiation dosimetry in healthy volunteers.


Condition Intervention Phase
Diagnostic Imaging
Drug: BAY1006578
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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 BAY1006578 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 BAY1006578 in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches [ Time Frame: Day 1 - day of study tracer administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by visual analysis and by standard parameters (e.g. Standardized Uptake Values=SUV) [ Time Frame: Day 1 - 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 ]
  • Adverse events collection [ Time Frame: Continuously and for a maximum of 28 days after end of observation phase ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY1006578
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
Experimental: Arm 2 Drug: BAY1006578
Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
Experimental: Arm 3 Drug: BAY1006578
Healthy volunteers for whole body imaging: Single intravenous bolus injection of 190 MBq BAY1006578, whole body PET for evaluation of effective dose, kinetics of BAY1006578 in blood

  Eligibility

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

Inclusion Criteria:

  • All:

    • Males or females aged >/- 50 years
    • Participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
  • Healthy volunteers for brain imaging:

    • Mini-Mental State Examination (MMSE) score of >/= 28
    • CDR score of zero (0)
  • Patients for brain imaging:

    • Patient fulfills Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's Disease (AD), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
    • Patient has mild to moderate dementia with a dementia score of >/= 20 on the Mini Mental State Examination (MMSE) / with a Clinical Dementia Rating score of 1 or 2 (CDR)

Exclusion Criteria:

  • All:

    • No significant disease or drug use
  • Patients for brain imaging:

    • Evidence for any other neurological or psychiatric disease
  • Healthy volunteers for brain imaging:

    • Family history of Alzheimer's Disease in a 1st or 2nd degree relative under 75 years of age
  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: NCT01153607

Locations
Finland
Turku, Finland, FIN-20520
Sweden
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Piramal Imaging SA
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01153607     History of Changes
Other Study ID Numbers: 14708, 2009-017166-24
Study First Received: April 23, 2010
Last Updated: January 18, 2013
Health Authority: Finland: Finish Medicine Agency
Sweden: Medicine Product Agency

Keywords provided by Piramal Imaging SA:
Alzheimer's disease
Diagnostic imaging
PET 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 July 29, 2014