Trial Condition(s):

Alzheimer Disease, Amyloid beta-protein

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

Bayer Identifier:

91783

ClinicalTrials.gov Identifier:

NCT01138111

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
45
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
NEURACEQ (Florbetaben F-18, BAY94-9172)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Department of Nuclear Medicine and Centre for PET

Heidelberg, Australia, 3084

Status
Completed
 

Trial Design