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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Alzheimer Disease Amyloid Beta-Protein

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Florbetaben (BAY94-9172)

Intervention Type DRUG

single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months

Interventions

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Florbetaben (BAY94-9172)

single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months

Intervention Type DRUG

Eligibility Criteria

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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
* \>/= 7 years of education

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No