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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

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Bayer

Status and phase

Completed
Phase 1

Conditions

Diagnostic Imaging

Treatments

Drug: F-18 DPA-714 (BAY85-8102)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01009359
13150
2009-009358-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 3 patient groups

Arm 1
Experimental group
Treatment:
Drug: F-18 DPA-714 (BAY85-8102)
Drug: F-18 DPA-714 (BAY85-8102)
Drug: F-18 DPA-714 (BAY85-8102)
Arm 2
Experimental group
Treatment:
Drug: F-18 DPA-714 (BAY85-8102)
Drug: F-18 DPA-714 (BAY85-8102)
Drug: F-18 DPA-714 (BAY85-8102)
Arm 3
Experimental group
Treatment:
Drug: F-18 DPA-714 (BAY85-8102)
Drug: F-18 DPA-714 (BAY85-8102)
Drug: F-18 DPA-714 (BAY85-8102)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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