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BMS-241027

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: Jul 24, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

BMS-241027 · 1 trial · 1 indication

Phase 1 1
NCT01492374Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's DiseaseAlzheimer's Disease
COMPLETED40 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction
Within the first 70 day after first dose
Biomarker Measures: CSF levels of Tau N-terminal domain fragments
Within the first 70 day after first dose

Secondary Endpoints

Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment
Within the first 70 days after first dose
Effects of BMS-241027 on cognitive performance using computerized cognitive tests
Weeks 3, 6 and 9
Effects of BMS-241027 on connectivity MRI
Within the first 70 days after first dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: BMS-241027 (0.003 mg/kg)EXPERIMENTAL -
Arm 2: BMS-241027 (0.01 mg/kg)EXPERIMENTAL -
Arm 3: BMS-241027 (0.03 mg/kg)EXPERIMENTAL -
Arm 4: Placebo matching BMS-241027EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-241027DRUGIntravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
Placebo matching BMS-241027DRUGIntravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks
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Eligibility Criteria

Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke - Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR) criteria * Mini-Mental State Ex...

Countries:United StatesCanadaFranceGermanySweden
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Frequently asked questions about BMS-241027

What is BMS-241027 used for in Alzheimer's Disease?

BMS-241027 is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It is intended for patients with mild Alzheimer's Disease, as evaluated in a clinical trial assessing its safety, tolerability, and effects on cerebrospinal fluid biomarkers. The drug is not approved and remains in clinical development.

What does BMS-241027 target?

The molecular target of BMS-241027 has not been disclosed in available information. The drug is a small molecule being investigated for its effects on cerebrospinal fluid biomarkers in patients with mild Alzheimer's Disease, but its specific mechanism of action is not publicly detailed.

Who makes BMS-241027?

BMS-241027 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company sponsored a Phase 1 clinical trial of the drug in patients with mild Alzheimer's Disease.

What phase is BMS-241027 in?

BMS-241027 is in Phase 1 clinical development. A Phase 1 trial evaluating the drug has been completed, but the drug remains investigational and has not received regulatory approval. Its safety and efficacy are still being studied in clinical trials.

What clinical trials is BMS-241027 in?

BMS-241027 has one completed clinical trial, identified as NCT01492374, titled "Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease." The trial enrolled 40 participants across the United States, Canada, France, Germany, and Sweden.