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DatSCAN

Phase 3

Lewy Body Dementia | Small molecule | Neurology |GE HealthCare Technologies Inc.|Last Updated: May 16, 2007

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
UNCONTROLLED
Total Trials1
Total Enrollment326
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00209456Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body DementiaPHASE3 COMPLETED 326Nov 1, 2003 -May 16, 20071 Germany
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Study Endpoints
Primary Endpoints
Sensitivity and specificity of DaTSCAN SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects.
Secondary Endpoints
Accuracy, positive predictive value and negative predictive value of DaTSCAN SPECT
Semi-quantitative analysis of the striatal uptake ratios of DaTSCAN SPECT images.
Impact of DaTSCAN SPECT analysis on the confidence of diagnosis.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
DatSCANDRUG -
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Eligibility Criteria
Age Range55 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects must be adults between 55 to 90 years of age with an established diagnosis for dementia in accordance with DSM-IV criteria and have to fulfil at least one of the following: The ICC criteria for probable and possible DLB, the National Institute of Neurological and Comm...

Countries:Germany
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