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

Phase 1

Completed

• Conditions: Diagnostic Imaging
• Interventions: Drug: BAY1006578

• Registration Number: NCT01153607
• Lead Sponsor: Life Molecular Imaging SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-23
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY1006578	-
Arm 2	BAY1006578	-
Arm 3	BAY1006578	-

Primary Outcome Measures

Name	Time	Method
Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches	Day 1 - day of study tracer administration

Secondary Outcome Measures

Name	Time	Method
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)	Day 1 - day of study tracer administration
Electrocardiogram (ECG)	At least once within 8 days after treatment
Blood pressure	At least 2 times within 8 days after treatment
Adverse events collection	Continuously and for a maximum of 28 days after end of observation phase