Overview

This trial is active, not recruiting.

Conditions mild cognitive impairment, alzheimer's disease
Treatment flutemetamol (18f) injection
Phase phase 3
Sponsor GE Healthcare
Collaborator Medpace, Inc.
Start date December 2009
End date April 2014
Trial size 225 participants
Trial identifier NCT01028053, GE-067-005

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
flutemetamol (18f) injection Flutemetamol
All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.

Primary Outcomes

Measure
To compare the time to conversion to clinically probable AD in aMCI subjects with normal and abnormal patterns of (18F) flutemetamol uptake based on the visual assessment of a PET scan.
time frame: Time zero equals the date of PET imaging. All subjects will subsequently attend follow-up visits every 6 months for approximately 3 years after the Flutemetamol (18F) Injection administration

Secondary Outcomes

Measure
To compare the time to conversion to clinically probable AD in aMCI subjects below and above a threshold of brain levels of (18F) flutemetamol uptake based on semi-quantitative assessment of a Flutemetamol (18F) Injection PET scan.
time frame: Time zero equals the date of PET imaging. All subjects will subsequently attend follow-up visits every 6 months for approximately 3 years after the Flutemetamol (18F) Injection administration

Eligibility Criteria

Male or female participants at least 60 years old.

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.

Additional Information

Official title A Principal Open-label Study to 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by GE Healthcare.