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

Life Molecular Imaging

Status and phase: Completed; Phase 1

Conditions: Diagnostic Imaging

Treatments: Drug: BAY1006578

Study type: Interventional

Funder types: Industry

Identifiers

NCT01153607

14708

2009-017166-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Arm 1

Experimental group

Treatment:

Drug: BAY1006578

Drug: BAY1006578

Drug: BAY1006578

Arm 2

Experimental group

Treatment:

Drug: BAY1006578

Drug: BAY1006578

Drug: BAY1006578

Arm 3

Experimental group

Treatment:

Drug: BAY1006578

Drug: BAY1006578

Drug: BAY1006578