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Completed

NCT Number: NCT01009359

Evaluation of the Neuroinflammation Pattern of BAY85-8102 F-18, DPA-714 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of F 18, DPA-714 in Healthy Volunteers

PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer.

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Key information

Conditions

Diagnostic Imaging Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

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

  • Able to give fully informed consent in writing
  • Males or females aged >/= 50 years
  • No significant disease or drug use
  • Absence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging:
  • Patient and designee capable of giving fully informed consent in writing
  • Patient fulfils DSM-IV and NINCDS-ADRA criteria for probable Alzheimers disease
  • Patient has undergone physical and neurological examination, ECG and test of routine hematological and biochemical parameters prior to radiotracer administration Exclusion Criteria:- Pregnancy or lactation
  • Current unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection)

Treatment and study plan

F-18 DPA-714 (BAY85-8102)

Drug

Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT

Primary outcomes

  1. Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approaches

    Time frame: Day of Study tracer administration

Secondary outcomes

  1. Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by visual analysis and standard parameters(e.g. Standardized Uptake Values = SUV)

    Time frame: 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. Serum protein

    Time frame: At least once within 8 days after treatment

  5. Serum creatinine

    Time frame: At least once within 8 days after treatment

  6. Serum GOT (Glutamat-Oxalacetate-Transaminase)

    Time frame: At least once within 8 days after treatment

  7. Adverse events collection

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open-label, Non-randomized, Multicenter Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq BAY85-8102 F-18, DPA-714 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 150 MBq BAY858102 F-18, DPA-714 in Healthy Volunteers.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2009
Registry last updated
Jul 31, 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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