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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

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

December 7, 2009
September 3, 2014
December 2009
January 2014   (final data collection date for primary outcome measure)
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).

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 2 years after the Flutemetamol (18F) Injection administration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01028053 on ClinicalTrials.gov Archive Site
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.
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 2 years after the Flutemetamol (18F) Injection administration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Mild Cognitive Impairment
  • Alzheimer's Disease
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
Experimental: Flutemetamol (18F) Injection
Flutemetamol (18F) Injection
Intervention: Drug: Flutemetamol (18F) Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
365
January 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028053
GE-067-005
Yes
GE Healthcare
GE Healthcare
  • Medpace, Inc.
  • i3 Statprobe
  • i3 Research
  • Quintiles
Study Chair: Paul Sherwin, M.D. GE Healthcare
GE Healthcare
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP