check_circleStudy Completed

Diagnostic Imaging

Bayer Identifier:

13150

ClinicalTrials.gov Identifier:

NCT01009359

EudraCT Number:

2009-009358-26

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

50 Years

  • - 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
  • - 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 summary

Enrollment Goal
22
Trial Dates
October 2009 - October 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
F18 DPA-714 (BAY85-8102)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Vrije Universiteit Medisch CentrumAmsterdam, 1081 HV, Netherlands
Completed
Clinical Research Services TurkuTurku, 20520, Finland

Primary Outcome

  • 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
    date_rangeTime Frame:
    Day of Study tracer administration
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    Day of Study tracer administration
    enhanced_encryption
    Safety Issue:
    no
  • Electrocardiogram (ECG)
    date_rangeTime Frame:
    At least once within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Blood pressure
    date_rangeTime Frame:
    At least 2 times within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Serum protein
    date_rangeTime Frame:
    At least once within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Serum creatinine
    date_rangeTime Frame:
    At least once within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Serum GOT (Glutamat-Oxalacetate-Transaminase)
    date_rangeTime Frame:
    At least once within 8 days after treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse events collection
    date_rangeTime Frame:
    Continuously and for a maximum of 28 days after end of observation phase
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
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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