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AH110690

Phase 2

Alzheimer's Disease | Small molecule | Neurology |GE HealthCare Technologies Inc.|Last Updated: Dec 7, 2009

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00785759Brain Uptake and Safety With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy VolunteersPHASE2 COMPLETED 78Sep 1, 2008Dec 1, 2009Dec 7, 20091 Norway
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Study Endpoints
Primary Endpoints
Examine the efficacy and determine visual assessment of raised [18F] brain uptake for separating subjects with probable Alzheimer's Disease from healthy volunteers and assigning amnestic mild cognitive impairment cases to an AD or HV category.
September 2008 - February 2009
Secondary Endpoints
Examine the efficacy and parameters of brain [18F] uptake for separating 25 subjects with probable AD from 25 HV, assigning 20 amnestic MCI cases to an AD or HV category by measuring ranges of regional cerebral to cerebellum tracer uptake ratios.
September 2008 - February 2009
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
AH110690 (18F) InjectionDRUGAll subjects will receive an I.V. dose of \[18F\]AH110690 (less than 10 mg of total AH110690). The target activity of a single administration of \[18F\]AH110690 will be 185 MBq (equivalent to a dose of approximately 6 mSv).
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Eligibility Criteria
Age Range25 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The subject meets National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for clinically probable AD and Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)...

Countries:Norway
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