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(3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6- YL)(PIPERIDIN-1-YL)METHANONE

This article discusses clinical trials investigating (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE, also known as NTRX-07, for patients with cognitive disorders. The research evaluates the safety, tolerability, and effects of this experimental treatment in individuals with mild cognitive impairment and Alzheimer’s disease through controlled clinical studies.

Table of Contents

Overview of Clinical Research

(3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE, designated as NTRX-07 in clinical development, is being investigated as an experimental treatment for cognitive disorders[1]. The clinical research program focuses on evaluating this compound in patients suffering from mild cognitive impairment (MCI) and Alzheimer’s disease (AD), two conditions that significantly impact memory, thinking abilities, and daily functioning[1].

The research is currently in Phase 2 of clinical development, which represents an important stage where investigators assess the safety profile and determine optimal dosing strategies in the target patient population[1]. This phase builds upon earlier research and aims to provide critical data about how the substance performs in individuals with cognitive impairment.

The clinical trial program for (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE addresses a significant unmet medical need in the treatment of Alzheimer’s disease and related cognitive disorders. These conditions affect millions of people worldwide and currently have limited treatment options that can slow disease progression or significantly improve symptoms.

Trial Design and Methodology

The clinical trial investigating (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE employs a rigorous multicenter, randomized, double-masked, placebo-controlled design[1]. This study design is considered the gold standard in clinical research because it minimizes bias and provides reliable evidence about treatment effects.

Key features of the trial design include:

  • Multicenter approach: The study is conducted at multiple research sites simultaneously, which helps ensure that results are applicable to diverse patient populations and different clinical settings[1].
  • Randomization: Participants are randomly assigned to receive either (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE or placebo, ensuring that treatment groups are comparable and reducing selection bias.
  • Double-masking: Neither the participants nor the researchers evaluating outcomes know who receives the active treatment versus placebo, preventing expectations from influencing the assessment of results[1].
  • Placebo control: Some participants receive an inactive substance that looks identical to the active treatment, allowing researchers to distinguish true drug effects from psychological or natural changes in the condition[1].

This methodological approach ensures that any observed benefits or side effects can be attributed specifically to (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE rather than other factors such as natural disease progression, patient expectations, or researcher bias.

Patient Population and Eligibility

The clinical trial enrolls a total of 48 participants who meet specific diagnostic criteria for cognitive impairment[1]. The study targets two distinct but related patient populations:

Mild Cognitive Impairment (MCI)

Patients with mild cognitive impairment represent an important group for early intervention research[1]. MCI is characterized by noticeable problems with memory or thinking that are greater than expected for a person’s age but do not significantly interfere with daily activities. People with MCI have an increased risk of developing Alzheimer’s disease, making them an important population for preventive treatment strategies.

Mild to Moderate Alzheimer’s Disease

The trial also includes patients diagnosed with mild to moderate Alzheimer’s disease[1]. These individuals experience more significant cognitive decline that affects their ability to perform daily tasks independently. In mild Alzheimer’s disease, patients may have trouble with complex tasks and show changes in personality or behavior. Moderate Alzheimer’s disease involves more pronounced memory loss, confusion, and difficulty with routine activities.

By including both MCI and Alzheimer’s disease patients, the research can evaluate whether (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE has potential benefits across different stages of cognitive decline. This broad patient population helps researchers understand whether the treatment might be useful for early intervention, symptom management, or both.

Study Objectives and Endpoints

The clinical trial has clearly defined objectives that guide the research and determine what information will be collected. The primary objective is to investigate the safety and tolerability of (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE when administered to patients with cognitive impairment[1].

Safety Assessment

Safety is evaluated primarily by monitoring and documenting adverse events that occur during the treatment period[1]. An adverse event is any unwanted medical occurrence in a patient, whether or not it appears related to the treatment. Researchers carefully track all adverse events to understand the safety profile of (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE and identify any potential risks.

The number and severity of adverse events provide critical information about whether the treatment can be safely administered to patients with cognitive disorders. This data helps determine whether the potential benefits of the treatment outweigh any risks.

Pharmacokinetic Evaluation

The trial includes pharmacokinetic (PK) assessments to understand how the body processes (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE[1]. Pharmacokinetic studies examine:

  • Absorption: How the substance enters the bloodstream after administration.
  • Distribution: How the compound spreads throughout the body tissues, including whether it reaches the brain effectively.
  • Metabolism: How the body chemically modifies the substance.
  • Elimination: How quickly the body removes the compound through urine, feces, or other routes.

Understanding these pharmacokinetic properties helps researchers determine appropriate dosing schedules and predict how the treatment might perform in different patient populations.

Pharmacodynamic Evaluation

The study also measures pharmacodynamic (PD) effects, which describe what (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE does to the body[1]. Pharmacodynamic assessments examine biological markers and physiological changes that may indicate the treatment is having its intended effect on brain function or disease processes.

These measurements help researchers understand the mechanism by which the compound might benefit patients with cognitive impairment and provide early signals about potential therapeutic effects.

Treatment Protocol and Duration

Participants in the clinical trial receive (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE for a period of 28 days[1]. This treatment duration represents a carefully selected timeframe that balances several important considerations:

The 28-day treatment period is sufficient to allow the substance to reach steady-state levels in the body, meaning that the amount absorbed with each dose equals the amount eliminated. This steady state is important for accurately assessing both safety and pharmacokinetic properties. The duration also allows time for potential therapeutic effects to emerge while being short enough to minimize patient burden in this Phase 2 trial.

During the 28-day treatment period, participants undergo regular monitoring to track their response to (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE. This includes scheduled visits to the research site where medical staff conduct examinations, collect blood samples for pharmacokinetic analysis, assess cognitive function, and record any adverse events.

The relatively short treatment duration in this Phase 2 trial is typical for early-stage research focused primarily on safety and tolerability. If the results demonstrate acceptable safety and promising signals of benefit, future Phase 3 trials would likely evaluate longer treatment periods to assess sustained efficacy and long-term safety.

Safety and Tolerability Monitoring

Safety monitoring represents the cornerstone of this Phase 2 clinical trial. The research team employs comprehensive methods to detect and evaluate any potential risks associated with (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE administration in patients with cognitive impairment.

Adverse Event Documentation

All adverse events occurring during the study are systematically documented and analyzed[1]. The research team classifies adverse events by severity (mild, moderate, or severe) and determines whether they are likely related to the study treatment. This careful assessment helps distinguish treatment-related side effects from symptoms of the underlying disease or unrelated medical problems.

Common categories of adverse events monitored in trials of cognitive disorders include changes in mood or behavior, gastrointestinal symptoms, sleep disturbances, and effects on cardiovascular or metabolic function. The research team pays particular attention to any adverse events that could pose serious risks to patient safety.

Tolerability Assessment

Tolerability refers to how well patients can manage the side effects of treatment[1]. Even if a treatment is medically safe, poor tolerability can lead patients to discontinue therapy, limiting its real-world effectiveness. The trial evaluates tolerability by tracking:

  • The proportion of patients who complete the full 28-day treatment course.
  • The frequency and severity of side effects that cause discomfort or concern.
  • Patient-reported outcomes regarding their experience with the treatment.
  • Any dose adjustments or treatment interruptions needed due to side effects.

Good tolerability is essential for any treatment intended for long-term use in chronic conditions like Alzheimer’s disease. If patients cannot tolerate the side effects, they are unlikely to continue treatment even if it provides cognitive benefits.

Trial Status and Regulatory Oversight

The clinical trial has received authorization from regulatory authorities to proceed[1]. This authorization indicates that the study protocol has been reviewed and approved by ethics committees and regulatory agencies who determined that the research design is scientifically sound and includes appropriate safeguards for participant safety.

Throughout the trial, an independent data safety monitoring board typically reviews accumulating safety data at regular intervals. This board can recommend modifications to the study protocol or even halt the trial if safety concerns emerge. This oversight provides an additional layer of protection for trial participants.

The multicenter nature of the trial also means that multiple institutional review boards have reviewed and approved the research, ensuring that ethical standards are maintained across all participating sites. These regulatory and ethical safeguards are fundamental to protecting the rights and welfare of patients who volunteer to participate in clinical research.

Trial ID Phase Condition Studied Status Enrollment Study Design Treatment Duration
2024-517957-29-00 Phase 2 Mild Cognitive Impairment and Mild to Moderate Alzheimer’s Disease Authorised 48 participants Multicenter, Randomized, Double-masked, Placebo-controlled 28 days

FAQ

  • What is being studied in clinical trials with (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE? Clinical trials are investigating (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE, known as NTRX-07, in patients with mild cognitive impairment and mild to moderate Alzheimer's disease. The studies evaluate safety, tolerability, and how the body processes the substance.
  • Who can participate in these clinical trials? The trials enroll patients diagnosed with mild cognitive impairment or mild to moderate Alzheimer's disease. Specific eligibility criteria are determined by the research team conducting the study.
  • What phase are the clinical trials in? The current clinical trial investigating (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE is in Phase 2. This phase focuses on evaluating safety and determining optimal dosing in the target patient population.
  • How long does the treatment last in these studies? In the clinical trial, patients receive (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE for 28 days. This duration allows researchers to assess short-term safety and effects of the treatment.
  • What is the main goal of these clinical trials? The primary objective is to investigate the safety and tolerability of (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6-YL)(PIPERIDIN-1-YL)METHANONE by monitoring adverse events. The trials also examine how the drug moves through the body and its effects on disease markers.

Ongoing Clinical Trials on (3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6- YL)(PIPERIDIN-1-YL)METHANONE

  • Study on the Safety and Effects of NTRX-07 for Patients with Mild Cognitive Impairment or Mild to Moderate Alzheimer’s Disease

    Recruiting

    1
    Investigated drugs:
    Czechia Hungary Poland

Glossary

  • Mild Cognitive Impairment (MCI): A condition where a person experiences noticeable decline in memory or thinking skills that is greater than expected for their age, but does not significantly interfere with daily activities. It can be a precursor to Alzheimer's disease.
  • Alzheimer's Disease (AD): A progressive brain disorder that gradually destroys memory, thinking skills, and the ability to perform simple tasks. It is the most common cause of dementia in older adults.
  • Phase 2 Clinical Trial: A stage of research that evaluates the safety and effectiveness of a treatment in a larger group of people, typically focusing on determining the optimal dose and monitoring side effects.
  • Pharmacokinetics (PK): The study of how the body absorbs, distributes, breaks down, and eliminates a drug over time. This helps researchers understand how long the drug stays in the body.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its therapeutic effects and mechanism of action. This examines what the drug does to the body at a biological level.
  • Double-masked Study: A research design where neither the participants nor the researchers know who is receiving the actual treatment versus placebo. This helps prevent bias in evaluating results.
  • Placebo-controlled: A study design where some participants receive an inactive substance (placebo) instead of the active treatment, allowing researchers to compare the true effects of the experimental drug.
  • Adverse Events: Any unwanted or harmful medical occurrence in a patient during a clinical trial, which may or may not be related to the treatment being studied.
  • Tolerability: The degree to which side effects of a treatment can be accepted or managed by patients. A well-tolerated drug causes minimal discomfort or adverse reactions.
  • Multicenter Study: A clinical trial conducted at multiple hospitals or research facilities simultaneously, which helps ensure diverse patient populations and more reliable results.

References

  1. https://clinicaltrials.gov/study/2024-517957-29-00