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
|ClinicalTrials.gov Identifier: NCT01028053|
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
|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.
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|