check_circleStudy Completed

Positron-Emission Tomography, Alzheimer's Disease

Bayer Identifier:

91683

ClinicalTrials.gov Identifier:

NCT01035164

EudraCT Number:

2006-006045-14

EU CT Number:

Not Available
Evaluation of ZK 6032924 in probable Alzheimer's disease patients versus healthy volunteers and the radiation dosimetry of ZK 6032924 in healthy volunteers

Trial purpose

PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.

Key Participants Requirements

Sex

Both

Age

50 Years
  • Patients for brain imaging:- patient and designee capable of giving fully informed consent in writing- patient fulfils DSM-IV and NINCDS-ADRDA criteria for probable Alzheimer's disease. Other forms of dementia excluded- males or postmenopausal females aged >/= 50 yearsHealthy volunteers for brain imaging: - able to give fully informed consent in writing- absence of any sign of dementia/cognitive impairment in neuropsychological examinations- males or postmenopausal females aged >/= 50 years Healthy volunteers for whole body imaging:- able to give fully informed consent in writing - males or postmenopausal females aged >/= 60 years - no significant disease or drug use
  • For all healthy volunteers and patients:- Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results

Trial summary

Enrollment Goal
25
Trial Dates
June 2007 - January 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
F18-FEDAA1106 (BAY85-8101)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, 171 76, Sweden
Completed
Karolinska Universitetssjukhuset HuddingeStockholm, 141 86, Sweden
Completed
Vrije Universiteit Medisch CentrumAmsterdam, 1081 HV, Netherlands

Primary Outcome

  • Visual analysis/description of the uptake and description of brain PET scans
    date_rangeTime Frame:
    Day of study tracer administration
    enhanced_encryption
    Safety Issue:
    no
  • Standardized uptake value (SUV) in various cerebral regions/volumes of interest (ROI/VOI) assumed and found to be involved in the pathophysiology of Alzheimer's disease.
    date_rangeTime Frame:
    Day of study tracer administration
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Standard quantification variables derived from 3D PET imaging and brain modeling
    date_rangeTime Frame:
    Day of study tracer administration
    enhanced_encryption
    Safety Issue:
    no
  • Standard Safety Measurement:adverse event collection
    date_rangeTime Frame:
    Maximum time from Screening to Follow up are 37 days
    enhanced_encryption
    Safety Issue:
    yes
  • Standard Safety Measurement:electrocardiogram
    date_rangeTime Frame:
    Maximum time from Screening to Follow up are 37 days
    enhanced_encryption
    Safety Issue:
    yes
  • Standard Safety Measurement:safety laboratory
    date_rangeTime Frame:
    Maximum time from Screening to Follow up are 37 days
    enhanced_encryption
    Safety Issue:
    yes
  • Standard Safety Measurement: vital signs
    date_rangeTime Frame:
    Maximum time from Screening to Follow up are 37 days
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Open-label, non-randomized, positron emission tomography (PET) imaging study to evaluate a single dose of 250 MBq (6.75 mCi) ZK 6032924 (18F-FEDAA1106) for its diagnostic potential in discriminating patients with probable Alzheimer's disease from healthy volunteers and to evaluate the radiation dosimetry of a single dose of 185 MBq (5 mCi) ZK 6032924 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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