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MABT5102A

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Last Updated: Jul 12, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment539

FDA Designations

No designations recorded

Clinical trial landscape

MABT5102A · 3 trials · 2 indications

Phase 2 2Phase 1 1
NCT01397578A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED91 Analytics
NCT01343966A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)Alzheimer's Disease
COMPLETED448 Analytics
PHASE2COMPLETED
A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in brain amyloid load as assessed by amyloid PET imaging
Baseline to Week 69
Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score
From baseline to Week 73
Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score
From baseline to Week 73
Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results)
Until study discontinuation

Secondary Endpoints

Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease
Baseline to Week 69
Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging
Baseline to Week 69
Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score
Baseline to Week 73
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Subcutaneous cohort expEXPERIMENTAL -
Part 2: Intravenous cohort expEXPERIMENTAL -
Part 1: Subcutaneous cohortPLACEBO_COMPARATORRepeating subcutaneous injection
Part 2: Intravenous cohortPLACEBO_COMPARATORRepeating intravenous injection
AEXPERIMENTAL -
BEXPERIMENTAL -

Interventions

NameTypeDescription
MABT5102ADRUGRepeating subcutaneous injection
placeboDRUGRepeating subcutaneous injection
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Eligibility Criteria

Age Range50 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria * Mini-Mental State Examination (MMSE) score of 18-26 points at screening * ...

Countries:United StatesFranceSpainCanadaGermanyUnited Kingdom
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Frequently asked questions about MABT5102A

What is MABT5102A used for?

MABT5102A is an investigational small molecule being studied for Alzheimer's disease and in healthy volunteers. It has been evaluated in clinical trials for mild to moderate Alzheimer's disease and in healthy volunteer studies to assess safety, tolerability, pharmacokinetics, and bioavailability.

Who makes MABT5102A?

MABT5102A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of this investigational drug in healthy volunteers and in patients with Alzheimer's disease.

What phase is MABT5102A in?

MABT5102A has completed Phase 2 clinical trials for Alzheimer's disease. It is an investigational drug that has not been approved by regulatory authorities, and its development status reflects completed studies rather than an ongoing clinical program.

What clinical trials is MABT5102A in?

MABT5102A has been studied in three completed trials: NCT00997919, a Phase 1 study in healthy volunteers; NCT01343966, a Phase 2 efficacy and safety study in Alzheimer's disease; and NCT01397578, a Phase 2 study on brain amyloid load and biomarkers in Alzheimer's disease.

Is MABT5102A the same as crenezumab?

MABT5102A is an investigational drug being developed by Roche. It has been studied under this name in clinical trials for Alzheimer's disease. No alternative names have been established for this compound in the available clinical trial information.