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IGC AD1

Phase 1

Dementia of Alzheimer Type | Small molecule | Neurology |IGC Pharma, Inc.|Last Updated: Sep 16, 2022

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04749563Study of IGC-AD1 in Subjects With Dementia Due to Alzheimer's DiseasePHASE1 COMPLETED 12Jan 11, 2021Jun 20, 2021Sep 16, 20221 Puerto Rico
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events in IGC-AD1 as compared to placebo [Safety and Tolerability]
3 weeks

Evaluate safety and tolerability of IGC AD1 10 participants will be administered the investigational drug and two will be administered placebo. Incidence of treatment emergent adverse events will be assessed to determine safety and tolerability of IGC-AD1.

Secondary Endpoints
Measurement of efficacy using Neuropsychiatric Inventory (NPI) scale
3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveACTIVE_COMPARATORIGC AD1
PlaceboPLACEBO_COMPARATORIGC AD1 Placebo
Interventions
NameTypeDescription
IGC AD1DRUGIGC AD1 oral Solution
PlaceboDRUGPlacebo of IGC AD1 oral Solution
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Eligibility Criteria
Age Range60 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patient and/or study partner (relative) must provide a signed and dated Informed Consent form prior to any study procedures which will be discussed with the Study Coordinator. 2. Provision of a letter from the Neurologist/Psychiatrist/Internal Medicine Physician certifying th...

Countries:Puerto Rico
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