Clinical trial NCT01153607: Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diagnostic Imaging
Keywords: Alzheimer's disease
Diagnostic imaging
PET diagnosis
PET tracer
Lead sponsor: Life Molecular Imaging SA
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches
timeFrame: Day 1 - day of study tracer administration
Secondary outcomes:
measure: 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)
timeFrame: Day 1 - day of study tracer administration
measure: Electrocardiogram (ECG)
timeFrame: At least once within 8 days after treatment
measure: Blood pressure
timeFrame: At least 2 times within 8 days after treatment
measure: Adverse events collection
timeFrame: Continuously and for a maximum of 28 days after end of observation phase
Other outcomes:
Locations:
city: Turku
country: Finland
city: Stockholm
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: