check_circleStudy Completed

Diagnostic Imaging

Bayer Identifier:

14708

ClinicalTrials.gov Identifier:

NCT01153607

EudraCT Number:

2009-017166-24

EU CT Number:

Not Available
Evaluation of the diagnostic potential of BAY1006578 in probable Alzheimers disease patients versus healthy volunteers and radiation dosimetry of BAY1006578 in healthy volunteers

Trial 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.

Key Participants Requirements

Sex

Both

Age

50 - 100 Years
  • - 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)
  • - 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 summary

Enrollment Goal
24
Trial Dates
June 2010 - October 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
[18F]FEMPA (BAY1006578)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Karolinska Universitetssjukhuset HuddingeStockholm, 141 86, Sweden
Completed
Turun yliopistollinen keskussairaala, kantasairaalaTurku, FIN-20520, Finland

Primary Outcome

  • Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches
    date_rangeTime Frame:
    Day 1 - day of study tracer administration
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    Safety Issue:
    No

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    Day 1 - day of study tracer administration
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    Safety Issue:
    No
  • Electrocardiogram (ECG)
    date_rangeTime Frame:
    At least once within 8 days after treatment
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    Safety Issue:
    Yes
  • Blood pressure
    date_rangeTime Frame:
    At least 2 times within 8 days after treatment
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    Safety Issue:
    Yes
  • Adverse events collection
    date_rangeTime Frame:
    Continuously and for a maximum of 28 days after end of observation phase
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    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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