Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01138111
First received: April 1, 2010
Last updated: January 18, 2013
Last verified: January 2013
  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.


Condition Intervention Phase
Alzheimer Disease
Amyloid Beta-Protein
Drug: Florbetaben (BAY94-9172)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ß-amyloid Imaging With BAY94-9172 Positron Emission Tomography for Early Detection of Alzheimer's Disease in Patients With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Quantitative assessment of neocortical SUVRs (Standard Uptake Value Ratios) as a measure of BAY94-9172 binding [ Time Frame: 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of normal and abnormal scans in patients with MCI progressing to AD and those who do not progress [ Time Frame: 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months ] [ Designated as safety issue: No ]
  • Brain ß-amyloid plaque load (BAPL) based on visual assessment [ Time Frame: 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months ] [ Designated as safety issue: No ]
  • Regional cortical tracer binding score (RCTB) in patients with MC [ Time Frame: 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months ] [ Designated as 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 [ Time Frame: 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months ] [ Designated as 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 [ Time Frame: 2 scanning periods post injection to be evaluated at baseline ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: June 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Florbetaben (BAY94-9172)
single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138111

Locations
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Piramal Imaging SA
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01138111     History of Changes
Other Study ID Numbers: 91783
Study First Received: April 1, 2010
Last Updated: January 18, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Piramal Imaging SA:
Florbetaben
Amyloid beta-protein
MCI
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014