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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028053
• Other study ID #: GE-067-005
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2009
• Last updated: September 3, 2014
• Start date: December 2009
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencySweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• Flutemetamol (18F) Injection
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.

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (5)

Lead Sponsor	Collaborator
GE Healthcare	i3 Research, i3 Statprobe, Medpace, Inc., Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation.	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).	Up to 36 months post flutemetamol administration	No
Secondary	The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period.	Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.	Up to 36 months post flutemetamol administration.	No