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TMS, H coil

Phase 2

Alzheimer's Disease | Unknown | Neurology |BrainsWay Ltd.|Last Updated: Jan 25, 2018

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01179373Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's DiseasePHASE2 COMPLETED 45Aug 1, 2010Jun 1, 2015Jan 25, 20181 Israel
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Study Endpoints
Primary Endpoints
cognitive functioning score by ADAS-COG
4 months
Secondary Endpoints
Global advancement score by CGI-C
4 months
Frontal lobe functioning score by FAB
4 months
Daily activity score by ADL
4 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TMS, High FrequencyACTIVE_COMPARATORHigh Frequency TMS with H coil to prefrontal cortex
TMS, Low FrequencyACTIVE_COMPARATORLow Frequency TMS to Prefrontal cortex
Sham StimulationPLACEBO_COMPARATORSham TMS with H Coil on Prefrontal Cortex
Interventions
NameTypeDescription
TMS, H coilDEVICETMS, H Coil, High/ Low Frequency
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Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Men and women aged 50-85. 2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria). 3. Scored below 24 on the MMSE. 4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 week...

Countries:Israel
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