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Drug Development.

Audrey Gabelle1, Marwan N Sabbagh2, Timo Grimmer3

  • 1Montpellier Excellence University, Montpellier, France.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 26, 2025
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Summary
This summary is machine-generated.

A new digital platform enables continuous monitoring of Alzheimer's disease drug efficacy and side effects using patient-reported outcomes, clinical assessments, and MRI imaging. This approach enhances personalized medicine and drug safety surveillance post-approval.

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Digital Health

Background:

  • Establishing robust Real-World Evidence (RWE) for Alzheimer's disease (AD) drug monitoring is crucial for personalized medicine.
  • Current standards for digital post-market drug safety and efficacy monitoring are lacking.
  • Oral blarcamesine, a novel precision medicine, is under review for marketing authorization.

Purpose of the Study:

  • To innovate the post-market monitoring of blarcamesine by developing a patient-centric, digital multimodal platform.
  • To enable continuous, real-time data collection for precise tracking of drug efficacy and side effects.
  • To enhance personalized medicine approaches in Alzheimer's disease treatment.

Main Methods:

  • The platform integrates digital Patient Reported Outcomes (PRO) via wearable devices.
  • It incorporates interactive digital applications for clinical and cognitive assessments.
  • Automated MRI brain imaging analysis using the QyScore® platform monitors brain volume changes.

Main Results:

  • The platform facilitates continuous, real-time data collection from patients.
  • Enables precise tracking of drug efficacy and individual patient responses.
  • Allows for early detection of potential adverse effects.

Conclusions:

  • The developed digital platform offers continuous post-market surveillance for Alzheimer's disease drugs.
  • It benefits all stakeholders, including patients, clinicians, regulators, and payors.
  • The modular design allows customization for monitoring other post-market treatments.