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

This study has been completed.
Sponsor:
Collaborators:
Medpace, Inc.
i3 Statprobe
i3 Research
Quintiles
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01028053
First received: December 7, 2009
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Mild Cognitive Impairment
Alzheimer's Disease
Drug: Flutemetamol (18F) Injection
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • 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. ] [ Designated as safety issue: No ]
    Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.


Enrollment: 365
Study Start Date: December 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028053

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Medpace, Inc.
i3 Statprobe
i3 Research
Quintiles
Investigators
Study Chair: Paul Sherwin, M.D. GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01028053     History of Changes
Other Study ID Numbers: GE-067-005
Study First Received: December 7, 2009
Results First Received: July 30, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 21, 2014