Pilot Trial Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases (NCT07049341) | Clinical Trial Compass
By InvitationNot Applicable
Pilot Trial Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases
United States100 participantsStarted 2025-07-31
Plain-language summary
Primary Objective:
The primary objective of this pilot study is to gain voluntary feedback from patients with neurological diseases and their caregivers regarding their experiences using the MemorEM head device. This information may help in new designs of the MemorEM and suggest ways to increase compliance for future clinical trials and eventual commercialization.
Secondary Objectives:
The secondary objective is to note areas of potential improvement in the progression of the subject's neurological disease and identify the potential for the MemorEM to treat neurological diseases other than Alzheimer's disease. We are also interested in Alzheimer's variants like those with ApoE4 alleles (none of the participants in the 8-person pilot were Apo-E4 positive), known mutations causing early onset Alzheimer's, and Posterior Cortical Atrophy.
Study Duration:
The study will be open-ended with patients continuing use of the MemorEM as they wish or when NeuroEM Therapeutics recalls the device. It is expected but optional that patients will use the devices for approximately two years.
Study Design:
This study will focus on the "patient experience" of using the MemorEM device over an extended time period. Patients will remain under the care of their physicians and will provide brief descriptions of their device experiences and any suggestions for improvements. This study will not require any interventions other than using the MemorEM device, which was rated as Non-Significant Risk by the Western IRB for the previous pilot trial including two extensions that raised no safety concerns over the two and a half years of treatment.
Study Population:
The study population will consist of various patients suffering from diagnosed neurological diseases. Patients may be selected from those diagnosed with Alzheimer's disease, Frontotemporal dementia, Posterior cortical atrophy, Corticobasal dementia, Parkinson's disease, and other neurological diseases.
Who can participate
Age range
45 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient diagnosed with a neurological disease involving aggregated proteins such as Alzheimer's and its variants, Parkinson's, Frontotemporal dementia, Amyotrophic lateral sclerosis, Tauopathies, and other related neurological diseases.
* Presence of a caregiver(s) responsible for ensuring treatment compliance and potentially with authority to make medical decisions for the patient if the patient is not competent to make those decisions
* Willing to sign NeuroEM's patient consent form
Exclusion Criteria:
* Patient has uncontrolled: Seizures, Epilepsy, Depression, Bipolar disorder, psychotic disorders, alcoholism or drug addiction
* Presence of metal implants in the head, except for metal dental implants
* Patient has hypertension that is unresponsive to anti-hypertensive medications
* Patient has implanted medication pumps unless cleared by physician
* Patient has significant heart disease, as determined by a physician
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is enrolling by invitation only, can you tell me whether you think I or my loved one might be considered a candidate, and how that invitation process works?
2This study is measuring what patients and caregivers think about the MemorEM device's design and how easy it is to use — not whether the device treats symptoms — so what do we actually know so far about whether this device has any clinical benefit for Alzheimer's, Parkinson's, or the other conditions listed?
3Because this is labeled as a pilot trial with no assigned phase, does that mean it's focused more on gathering feedback about the device experience rather than testing safety or effectiveness, and what does that mean for my expectations if we participate?
4The trial covers several different neurological conditions, including Alzheimer's disease, Parkinson's disease, and Posterior Cortical Atrophy — given my specific diagnosis, do you think the findings from this kind of study would be relevant to my situation?
5What would participating actually involve day-to-day for me or my caregiver, and is there a standard treatment option we should consider first before looking at a pilot study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient and caregiver reports on device design and use
Timeframe: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.