check_circleStudy Completed

Alzheimer Disease, Amyloid beta-Protein

Florbetaben (BAY94-9172) PET (Positron Emission Tomography) imaging in MCI (mild cognitive impairment) patients

Trial purpose

The aim of the study is to investigate whether Florbetaben-BAY94-9172 positron emission tomography (PET) has any ability to distinguish patients with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.

Key Participants Requirements

Sex

Both

Age

60 - N/A
  • - Presence of MCI defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss.
    - Absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years.
    - Able to give written informed consent.
    - Age >/= 60 years of age.
  • - Mini mental state examination (MMSE) score < 24 at baseline
    - Clinical dementia rating (CDR) score > 0.5 at baseline
    - Patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics)
    - Existing or history of cancer
    - History of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion
    - Lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder
    - Contraindications to MRI (Magnetic resonance imaging)
    - Relevant history, physical or imaging findings of neurological disease other than MCI and mild depression
    - History of severe anaphylactic reaction or high risk of allergic reaction to drugs
    - Patient has received another investigational drug in the preceding 14 days

Trial summary

Enrollment Goal
45
Trial Dates
June 2008 - December 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
NEURACEQ (Florbetaben F-18, BAY94-9172)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Department of Nuclear Medicine and Centre for PETHeidelberg, 3084, Australia

Primary Outcome

  • Quantitative assessment of neocortical SUVRs (Standard Uptake Value Ratios) as a measure of BAY94-9172 binding
    date_rangeTime Frame:
    1 scanning period post injection to be evaluated at baseline, 12 months and 24 months
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Percentage of normal and abnormal scans in patients with MCI progressing to AD and those who do not progress
    date_rangeTime Frame:
    1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months
    enhanced_encryption
    Safety Issue:
    no
  • Brain ß-amyloid plaque load (BAPL) based on visual assessment
    date_rangeTime Frame:
    2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months
    enhanced_encryption
    Safety Issue:
    no
  • Regional cortical tracer binding score (RCTB) in patients with MC
    date_rangeTime Frame:
    2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months
    enhanced_encryption
    Safety Issue:
    no
  • Number and proportion of normal and abnormal scans based on Brain ß-amyloid plaque load (BAPL) in patients with MCI converting to AD and those who do not progress
    date_rangeTime Frame:
    2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months
    enhanced_encryption
    Safety Issue:
    no
  • Sensitivity and specificity of BAY94-9172 PET imaging at baseline in the detection of significant brain ß-amyloid plaque load in patients with MCI progressing to AD compared to those who do not progress
    date_rangeTime Frame:
    2 scanning periods post injection to be evaluated at baseline
    enhanced_encryption
    Safety Issue:
    no

Trial design

ß-amyloid imaging with BAY94-9172 positron emission tomography for early detection of Alzheimer's disease in patients with mild cognitive impairment
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1