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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

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ClinicalTrials.gov Identifier: NCT01028053
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Collaborators:
Medpace, Inc.
i3 Statprobe
i3 Research
Quintiles, Inc.
Information provided by (Responsible Party):
GE Healthcare

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer's Disease Drug: Flutemetamol (18F) Injection Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : December 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Flutemetamol (18F) Injection
Flutemetamol (18F) Injection
 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.
Other Names:
  • Flutemetamol
  • 18F


Outcome Measures
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Primary Outcome Measures :
  1. Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. [ Time Frame: 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 :
  1. The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. [ Time Frame: Up to 36 months post flutemetamol administration. ]
    Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028053


Locations
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United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Medpace, Inc.
i3 Statprobe
i3 Research
Quintiles, Inc.
Investigators
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Study Chair: Paul Sherwin, M.D. GE Healthcare
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01028053    
Other Study ID Numbers: GE-067-005
First Posted: December 9, 2009    Key Record Dates
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014
Last Verified: September 2014
Keywords provided by GE Healthcare:
Mild Cognitive Impairment
Positron Emission Tomography
National Institute of Neurological and Communicative Disorders and Stroke
Alzheimer's Disease and Related Disorders Association
Assess Prognostic Usefulness of Flutemetamol Injection for Identifying Subjects who will Convert to Clinically Probable Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Flutemetamol
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action