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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01028053|
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Alzheimer's Disease||Drug: Flutemetamol (18F) Injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||365 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||60 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Chair:||Paul Sherwin, M.D.||GE Healthcare|
|Responsible Party:||GE Healthcare|
|Other Study ID Numbers:||
|First Posted:||December 9, 2009 Key Record Dates|
|Results First Posted:||September 11, 2014|
|Last Update Posted:||September 11, 2014|
|Last Verified:||September 2014|
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
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action