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

Phase 3

Completed

• Conditions: Mild Cognitive Impairment; Alzheimer's Disease
• Interventions: Drug: Flutemetamol (18F) Injection

• Registration Number: NCT01028053
• Lead Sponsor: GE Healthcare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2014-07-30
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-03
• Last Update Submitted: 2014-09-03
• Results First Posted: 2014-09-11
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flutemetamol (18F) Injection	Flutemetamol (18F) Injection	Flutemetamol (18F) Injection

Primary Outcome Measures

Name	Time	Method
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation.	Up to 36 months post flutemetamol administration	Visual Interpretation of the PET scan by independent readers.; Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.; As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases.; Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included).

Secondary Outcome Measures

Name	Time	Method
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period.	Up to 36 months post flutemetamol administration.	Numbers of subjects with normal and abnormal patterns of \[18F\]flutemetamol uptake who converted to pAD.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States