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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Drug Development.

Lisa Fosdick1, Giacomo Koch1,2

  • 1Sinaptica Therapeutics, Cambridge, MA, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 26, 2025
PubMed
Summary

This study investigates neuromodulation of the default mode network (nDMN) for Alzheimer's disease (AD). The RETAIN trial aims to assess if nDMN is a safe and effective treatment for mild to moderate AD patients.

Area of Science:

  • Neuroscience
  • Neurology
  • Clinical Trials

Background:

  • Altered cortical plasticity is a hallmark of Alzheimer's disease (AD).
  • Non-invasive brain stimulation offers a potential therapeutic approach to restore cortical plasticity and synaptic activity.
  • Previous trials established the safety and feasibility of neuromodulation of the default mode network (nDMN) for mild to moderate AD.

Purpose of the Study:

  • To evaluate the efficacy and safety of nDMN in patients with mild to moderate AD.
  • To explore the mechanism of action of nDMN as a treatment modality for AD.
  • To serve as a pivotal trial supporting a De Novo classification request to the FDA.

Main Methods:

  • Prospective, multi-center, double-blind, randomized controlled trial (RETAIN trial).

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  • Inclusion of patients with mild to moderate AD (stage 4-5, CDR 0.5-2.0) with positive biomarkers and recent memory decline.
  • Treatment involves a 10-day initiation and 22 weekly sessions of nDMN via the Sinaptistim system with personalized target/intensity selection using TMS-EEG; active treatment (2/3) vs. sham (1/3).

    • Main Results:

    • Efficacy will be assessed using cognitive and functional measures (ADAS-Cog13, ADCS-ADL, CDR).
    • Neuroimaging (MRI, fMRI) and plasma biomarkers of neurodegeneration and synaptic activity will be analyzed.
    • The study is designed with a seamless adaptive P2/P3 design with interim analyses for sample size adjustment (minimum 120 participants).

    Conclusions:

    • The RETAIN trial is designed to determine the efficacy and safety of nDMN for mild to moderate AD.
    • Sub-studies and exploratory analyses will further investigate the treatment's mechanism of action.
    • The trial's results are intended to support a FDA De Novo classification request.