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Completed

NCT Number: NCT01153607

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Turku, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1006578

Drug

Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Electrocardiogram (ECG)

    Time frame: At least once within 8 days after treatment

  3. Blood pressure

    Time frame: At least 2 times within 8 days after treatment

  4. Adverse events collection

    Time frame: Continuously and for a maximum of 28 days after end of observation phase

Sponsors and collaborators

Lead sponsor

Lantheus Biosciences Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2010
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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