Advancing Alzheimer’s Care Through Clinical Trials: How 1MED Supports Innovation in Medical Devices
Discover how 1MED advances Alzheimer’s care through clinical trials of innovative medical devices for diagnosis, sleep safety, and daily life support.
Alzheimer’s disease is one of the most pressing health challenges of our time. As a progressive neurodegenerative condition, it impacts memory, cognition, behavior, and overall quality of life—placing a heavy burden not only on those diagnosed but also on their families, caregivers, and healthcare systems worldwide. The pursuit of better care and, ultimately, a cure demands relentless innovation—and clinical trials are at the heart of that mission.
At 1MED, we are proud to support the development and clinical evaluation of medical devices that are reshaping how Alzheimer’s disease is diagnosed, monitored, and managed. With end-to-end support for clinical investigations, we help MedTech innovators bring transformative technologies to the patients who need them most.
The Role of Clinical Trials in Alzheimer’s Care
Clinical trials are essential to medical progress. They provide a structured, scientifically rigorous framework to evaluate new treatments, technologies, and care models. In Alzheimer’s research, clinical trials are indispensable for:
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Validating diagnostic tools, such as wearable sensors, neuroimaging systems, and AI-powered analysis tools that detect early signs of cognitive decline.
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Testing therapeutic interventions, including neuromodulation devices, implantables, and non-invasive systems like TMS and DBS.
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Ensuring safety and compliance for vulnerable populations such as elderly patients and those with cognitive impairments.
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Enhancing quality of life, by assessing technologies that support daily care, reduce risk, and help caregivers provide safer, more personalized assistance.
Through participation in clinical trials, patients and caregivers not only gain early access to promising solutions—they also help advance the global body of knowledge on Alzheimer’s disease.
Breakthroughs in Alzheimer’s Medical Devices
The past decade has seen a wave of innovation in medical devices designed to address key challenges in Alzheimer’s care. These devices aim to improve early diagnosis, enable more targeted treatment, and enhance daily life for patients.
1. Diagnostic Technologies
Neuroimaging tools, combined with wearable biosensors, are revolutionizing the early detection of Alzheimer’s by identifying subtle cognitive or physiological changes.
These technologies enable earlier intervention, which may delay the progression of the disease and help patients retain independence for longer.
2. Prognostic Tools
Devices that utilize biomarker analysis (such as amyloid or tau protein levels in cerebrospinal fluid) can now help predict disease progression and response to specific therapies.
This allows healthcare providers to personalize treatment plans, increasing the chances of positive outcomes and minimizing side effects.
3. Therapeutic Innovations
Advanced neurostimulation techniques like Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) are being evaluated for their ability to modulate neural activity and potentially improve memory, mood, and brain function.
While these approaches are still in investigational stages for Alzheimer’s, early clinical trials have shown encouraging results.
4. Daily Life Enhancements
Smart home systems, wearable safety devices, and mobile applications are being integrated into care routines. These tools help track mood, sleep patterns, cognitive function, and medication adherence—while giving caregivers alerts in real time.
Such innovations are especially valuable for monitoring at home and enabling remote care support.
Why Sleep Is Critical in Alzheimer’s Management
Sleep disturbances are a hallmark symptom of Alzheimer’s disease and often worsen as the disease progresses. Common issues include:
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Difficulty falling or staying asleep
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Frequent nighttime awakenings
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Early morning waking
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Sundowning (increased confusion and agitation in the evening)
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Nighttime wandering, which poses significant safety risks
It is estimated that up to 50% of individuals with moderate to severe Alzheimer’s experience significant sleep-related symptoms.
Beyond the immediate impact on rest and well-being, poor sleep can accelerate cognitive decline, increase the risk of falls, and place added strain on caregivers. That’s why securing healthy sleep patterns is becoming a growing focus of Alzheimer’s research.
Spotlight on Our Latest Clinical Investigation
At 1MED, we are currently managing a clinical investigation designed to address one of Alzheimer’s most challenging symptoms: sleep-related safety risks.
This interventional study evaluates a Class I medical device designed to secure patients during nighttime episodes of disorientation, agitation, and wandering—common behaviors that can lead to injuries or interfere with essential medical treatments.
Study Highlights:
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Type: Interventional, multicenter, prospective, non-comparative
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Sites: 11 clinical establishments across France
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Target Enrollment: 108 patients
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Primary Objective: To assess the safety of a novel bedding system for patients at risk of:
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Nighttime disorientation or behavioral disturbances
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Undressing or removing medical tubes/devices
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Falls from bed during sleep
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Cognitive crises (e.g., sundowning)
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1MED’s Contribution:
We offer comprehensive support across the entire clinical investigation lifecycle, including:
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Regulatory Strategy & Submissions (CE-marking and MDR compliance)
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Protocol Design & Clinical Operations
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Site & Investigator Coordination
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Monitoring & Data Quality Oversight (GCP compliance)
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Adverse Event Reporting & Safety Management
Ethical considerations are central to this project, with safeguards in place to protect the dignity and autonomy of participating patients.
Looking Ahead
The study results are expected by the end of 2025 and could pave the way for wider adoption of safety-enhancing devices in Alzheimer’s care settings, including hospitals, nursing homes, and home environments.
At 1MED, we believe that every innovation—no matter how small—brings us one step closer to better, more compassionate care for those living with Alzheimer’s disease.
From diagnosis and prognosis to treatment and daily life support, we are committed to advancing MedTech that truly makes a difference.
Learn more about how 1MED is supporting innovation in neurodegenerative disease care:
🌐 www.1med.ch