Trial Outcomes & Findings for 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 (NCT NCT01028053)

Last Updated: 2014-09-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

365 participants

Primary outcome timeframe

Up to 36 months post flutemetamol administration

Results posted on

2014-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Flutemetamol (18F) Injection 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 Study STARTED	365
Overall Study COMPLETED	232
Overall Study NOT COMPLETED	133

Reasons for withdrawal

Reasons for withdrawal
Measure	Flutemetamol (18F) Injection 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 Study Screen Failure	113
Overall Study Patient Request	11
Overall Study Protocol Violation	1
Overall Study Physician Decision	2
Overall Study Technical Problem	1
Overall Study Terminated by Sponsor	1
Overall Study Various reasons	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flutemetamol (18F) Injection n=232 Participants 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.
Age, Continuous	71.1 years STANDARD_DEVIATION 8.62 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants
Age, Categorical >=65 years	169 Participants n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants
Region of Enrollment Belgium	13 participants n=5 Participants
Region of Enrollment Denmark	8 participants n=5 Participants
Region of Enrollment Finland	15 participants n=5 Participants
Region of Enrollment Sweden	7 participants n=5 Participants
Region of Enrollment United Kingdom	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months post flutemetamol administration

Population: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included).

Outcome measures

Outcome measures
Measure	Hazard Ratio n=224 Participants 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.	Clinically Probable Alzheimer's Disease 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).
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. Reader 1 - Visual Interpretation	3.418 Ratio of visual interpretations	—
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. Reader 2 - Visual Interpretation	1.962 Ratio of visual interpretations	—
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. Reader 3 - Visual Interpretation	2.561 Ratio of visual interpretations	—
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. Reader 4 - Visual Interpretation	2.633 Ratio of visual interpretations	—
Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer's Disease Based on Visual Image Interpretation. Reader 5 - Visual Interpretation	2.580 Ratio of visual interpretations	—

SECONDARY outcome

Timeframe: Up to 36 months post flutemetamol administration.

Population: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 - 8 = 224 Subjects included).

Numbers of subjects with normal and abnormal patterns of \[18F\]flutemetamol uptake who converted to pAD.

Outcome measures

Outcome measures
Measure	Hazard Ratio n=143 Participants 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.	Clinically Probable Alzheimer's Disease n=81 Participants 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).
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 1 - Normal	111 Number of subjects	31 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 1 - Abnormal	32 Number of subjects	50 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 2 - Normal	72 Number of subjects	21 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 2 - Abnormal	71 Number of subjects	60 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 3 - Normal	108 Number of subjects	37 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 3 - Abnormal	35 Number of subjects	44 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 4 - Normal	98 Number of subjects	28 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 4 - Abnormal	45 Number of subjects	53 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 5 - Normal	98 Number of subjects	29 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Reader 5 - Abnormal	45 Number of subjects	52 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Majority Reads - Normal	98 Number of subjects	29 Number of subjects
The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer's Disease (pAD) Within the Follow up Period. Majority Reads - Abnormal	45 Number of subjects	52 Number of subjects

Adverse Events

Flutemetamol (18F) Injection

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flutemetamol (18F) Injection n=232 participants at risk 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.
Immune system disorders Anaphylactoid Reaction	0.43% 1/232 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Paul Sherwin M.D.

GE Healthcare

Phone: 16095146820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place