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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Mild Cognitive Impairment
Alzheimer's Disease
Intervention Drug: Flutemetamol (18F) Injection
Enrollment 365
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flutemetamol (18F) Injection
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 365
Completed 232
Not Completed 133
Reason Not Completed
Screen Failure             113
Patient Request             11
Protocol Violation             1
Physician Decision             2
Technical Problem             1
Terminated by Sponsor             1
Various reasons             4
Arm/Group Title Flutemetamol (18F) Injection
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 232
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 232 participants
71.1  (8.62)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants
<=18 years
0
   0.0%
Between 18 and 65 years
63
  27.2%
>=65 years
169
  72.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants
Female
118
  50.9%
Male
114
  49.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants
United States 109
Belgium 13
Denmark 8
Finland 15
Sweden 7
United Kingdom 80
1.Primary Outcome
Title Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer’s Disease Based on Visual Image Interpretation.
Hide Description

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).

Time Frame Up to 36 months post flutemetamol administration
Hide Outcome Measure Data
Hide Analysis Population Description
Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).
Arm/Group Title Hazard Ratio
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 224
Measure Type: Number
Unit of Measure: Ratio of visual interpretations
Reader 1 - Visual Interpretation 3.418
Reader 2 - Visual Interpretation 1.962
Reader 3 - Visual Interpretation 2.561
Reader 4 - Visual Interpretation 2.633
Reader 5 - Visual Interpretation 2.580
2.Secondary Outcome
Title The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer’s Disease (pAD) Within the Follow up Period.
Hide Description Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.
Time Frame Up to 36 months post flutemetamol administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).
Arm/Group Title Not Clinically Probable Alzheimer’s Disease Clinically Probable Alzheimer’s Disease
Hide Arm/Group Description:
A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to not clinically probable Alzheimer’s Disease (pAD).
A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to clinically probable Alzheimer’s Disease (pAD).
Overall Number of Participants Analyzed 143 81
Measure Type: Number
Unit of Measure: Number of subjects
Reader 1 - Normal 111 31
Reader 1 - Abnormal 32 50
Reader 2 - Normal 72 21
Reader 2 - Abnormal 71 60
Reader 3 - Normal 108 37
Reader 3 - Abnormal 35 44
Reader 4 - Normal 98 28
Reader 4 - Abnormal 45 53
Reader 5 - Normal 98 29
Reader 5 - Abnormal 45 52
Majority Reads - Normal 98 29
Majority Reads - Abnormal 45 52
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flutemetamol (18F) Injection
Hide Arm/Group Description Flutemetamol (18F) Injection: All subjects will receive an intravenous dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
All-Cause Mortality
Flutemetamol (18F) Injection
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Flutemetamol (18F) Injection
Affected / at Risk (%) # Events
Total   1/232 (0.43%)    
Immune system disorders   
Anaphylactoid Reaction  1  1/232 (0.43%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flutemetamol (18F) Injection
Affected / at Risk (%) # Events
Total   0/232 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Paul Sherwin M.D.
Organization: GE Healthcare
Phone: 16095146820
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01028053     History of Changes
Other Study ID Numbers: GE-067-005
First Submitted: December 7, 2009
First Posted: December 9, 2009
Results First Submitted: July 30, 2014
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014