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Flutemetamol

Phase 3

Brain Fibrillarab Levels | Small molecule | Other |GE HealthCare Technologies Inc.|Last Updated: Dec 4, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment203
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01165554Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem LevelsPHASE3 COMPLETED 203 — — May 1, 2010Nov 1, 2011Dec 4, 20131 United States
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Study Endpoints
Primary Endpoints
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.
Post flutemetamol administration.

A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of \[18F\]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.

Secondary Endpoints
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.
Post Flutemetamol administrations
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.
Post flutemetamol administration.
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.
Post flutemetamol administration.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
[18F] FlutemetamolEXPERIMENTAL -
Interventions
NameTypeDescription
[18F] FlutemetamolDRUGFlutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.
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Eligibility Criteria
Age Range55 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator. * The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia. * The subject's general health is adequate to ...

Countries:United States
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