Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease

General Electric (GE)

Status and phase

Completed

Phase 3

Conditions

Alzheimer's Disease

Mild Cognitive Impairment

Treatments

Drug: Flutemetamol (18F) Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01028053

GE-067-005

Details and patient eligibility

About

This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.

Enrollment

365 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The subject is 60 years old or older.
The subject meets the Petersen criteria for amnestic MCI.
The subject has a score of less than or equal to 4 on the Modified Hachinski Ischemic Scale.
The subject has a MMSE score of 24-30.
The subject has a non-contrast MRI examination as part of the screening visit that excludes aMCI arising from structural causes.
The subject and/or the subject's legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent.

Exclusion criteria

The subject has any significant neurologic disease other than suspected aMCI; such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
The subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments or pacemakers that would pose a risk during an MRI.
The subject has major depression, bipolar disorder, as described in the DSM-IV within the past year.
The subject has history of schizophrenia (DSM-IV criteria).
The subject has had, within the prior 3 months, psychotic features, agitation or behavioral problems that could lead to protocol compliance issues.