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

Life Molecular Imaging

Status and phase

Completed

Phase 1

Conditions

Alzheimer Disease

Amyloid Beta-Protein

Treatments

Drug: Florbetaben (BAY94-9172)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01138111

312043

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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