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VX-745

Phase 2

Alzheimer's Disease | Small molecule | Neurology |CervoMed Inc.|Last Updated: Jun 14, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

VX-745 · 2 trials · 2 indications

Phase 2 2
NCT02423122A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)Alzheimer's Disease
COMPLETED16 Analytics
NCT02423200Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild ADAlzheimer's Disease
COMPLETED16 Analytics
PHASE2COMPLETED
A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)
Alzheimer's DiseaseUnlock trial analytics
PHASE2COMPLETED
Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET
Baseline compared to following 12 weeks' dosing with VX-745

Percent change in global cortical amyloid specific PET signal (BPND)

Number of 11C-PiB Responders
Day 84

Number of patients meeting protocol pre-specified definition of response: \> 7% reduction in global cortical BPND

Percent Change From Baseline to End of Treatment in Cerebrospinal Fluid Levels of Cytokines
Baseline and Day 42 of dosing with VX-745

Cytokines: Of nine cytokines assessed, only CSF IL-8 quantifiable at all time points. And so, only IL-8 levels are being reported herein. The analysis was exploratory and no statistical analysis was performed.

Secondary Endpoints

Wechsler Memory Scale (WMS) Immediate Recall Composite
Baseline to Day 84
Wechsler Memory Scale (WMS) Delayed Recall Composite
Change from baseline to Day 84
Severe or Serious Adverse Events
At baseline and at each study visit during (days 1, 7, 14, 21, 28, 35 and 42) and after (day 51) dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VX-745 dose 1EXPERIMENTALActive Group 1: VX-745 40 mg twice daily
VX-745 dose 2EXPERIMENTALActive Group 2: VX-745 125 mg twice daily
VX-745 dose level 1EXPERIMENTALActive Group 1: VX-745 dose level 1 twice daily
VX-745 dose level 2EXPERIMENTALActive Group 1: VX-745 dose level 2 twice daily

Interventions

NameTypeDescription
VX-745DRUGOrally-Active Selective P45 MAP Kinase inhibitor
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Eligibility Criteria

Age Range60 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Willing and able to provide informed consent * Diagnosis of mild cognitive impairment (MCI) due to probable AD or of mild AD * MMSE range: 20 to 28 * Evidence of amyloid pathology by amyloid PET scan * Participants may be taking medications for AD, provided that the dose of th...

Countries:NetherlandsUnited States
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Frequently asked questions about VX-745

What is VX-745 used for in Alzheimer's Disease?

VX-745 is an investigational small molecule being studied for Alzheimer's Disease. It is a p38 MAP kinase inhibitor that has been evaluated in Phase 2 clinical trials for patients with mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease. The drug is not approved and remains in clinical development.

What does VX-745 target?

VX-745 targets p38 MAP kinase, an enzyme involved in inflammatory signaling pathways. By inhibiting this kinase, the drug is being investigated for its potential effects on Alzheimer's Disease, including its impact on amyloid plaque load in the brain.

Who makes VX-745?

VX-745 is being developed by CervoMed Inc., a biopharmaceutical company. CervoMed's stock is traded under the ticker symbol CRVO. The company is conducting clinical research on this investigational drug for Alzheimer's Disease.

What phase is VX-745 in?

VX-745 is in Phase 2 clinical development. It has completed two Phase 2 trials, with a total of 32 participants enrolled. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is VX-745 in?

VX-745 has completed two Phase 2 trials. NCT02423122 studied its effects on amyloid plaque load in Alzheimer's Disease and mild cognitive impairment in the Netherlands. NCT02423200 evaluated its clinical pharmacology in mild cognitive impairment due to Alzheimer's Disease or mild AD in the United States.

Is VX-745 the same as other names?

VX-745 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information. It is identified solely as VX-745 in the studies conducted by CervoMed Inc.