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Memantine

Phase 2

Radiation Disease | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Sep 19, 2024

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 Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06594172Early Application of Memantine and Pioglitazone to Protect Cognitive Function After RadiotherapyPHASE2 NOT YET_RECRUITING 67Sep 10, 2024Jun 30, 2027Sep 19, 2024 -
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Study Endpoints
Primary Endpoints
the cumulative incidence of cognitive failure
At weeks 4, 8, 16, 24, 36, and 48 after the completion of radiotherapy

the proportion of participants who experience cognitive impairments after radiation therapy

Secondary Endpoints
Cognitive Score Decline
At weeks 4, 8, 16, 24, 36, and 48 after the completion of radiotherapy
Progressive-free survival for Intracranial Tumors
At weeks 4, 8, 16, 24, 36, and 48 after the completion of radiotherapy
Overall Survival
At weeks 4, 8, 16, 24, 36, and 48 after the completion of radiotherapy
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MPREXPERIMENTALcombined Memantine and Pioglitazone with radiation therapy
Interventions
NameTypeDescription
Memantine Oral TabletDRUGOral administration of Memantine Tablets (10mg/tablet): Week 1: 5mg in the morning. Week 2: 5mg twice daily. Week 3: 10mg in the morning, 5mg in the evening. Weeks 4-24: 10mg twice daily.
Pioglitazone 15mgDRUGSimultaneous oral administration of Pioglitazone Tablets (15mg/tablet): Weeks 1-24: 30mg once daily.
Hippocampal avoidance whole-brain radiotherapy (HA-WBRT)RADIATIONBased on the RTOG 0933 protocol, hippocampal and perihippocampal regions are delineated, and hippocampal dose constraints are applied. The radiation dose to the perihippocampal region is determined based on the size, number, and volume of brain metastases (whole-brain radiation therapy: DT 30Gy/10F, weeks 1-2; with a simultaneous boost to the pathological local area if necessary, 10-20Gy).
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Recursive Partitioning Analysis (RPA), Class I \~ Class II * Karnofsky Performance Status of ≥70 * The primary tumor must be pathologically confirmed. For newly diagnosed brain metastases, the number of metastases is not limited, but the brain metastases could not have been wi...

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