Alzheimer's DiseaseNCT07049341
Pilot Trial Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases
A study testing MemorEM in people with Alzheimer's Disease and Fronto-temporal Dementia, run by NeuroEM Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Alzheimer's Disease, Fronto-temporal Dementia, Parkinson Disease (PD)
- What is being tested?
- MemorEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Alzheimer's Disease, Fronto-temporal Dementia, Parkinson Disease (PD), Cortico Basal Degeneration, Posterior Cortical Atrophy (PCA), Neurological Diseases or Conditions
- Being tested
- MemorEM
- Medical subject headings
- Parkinson Disease, Corticobasal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemorEMDevice
The MemorEM device delivers 915MHz electromagnetic waves to the head via 8 emitters in a cap worn on the head and powered by a control box and battery worn on the arm.
| Study group | Role | What they receive |
|---|---|---|
| Patient Experience Arm | Active comparator | Not described Receives: Device: MemorEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and caregiver reports on device design and use
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 will be gathered via a monthly survey. This information may help in new designs of the MemorEM and suggest ways to increase compliance for future clinical trials and eventual commercialization.
Measured: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.
Secondary outcomes (1)
Reports of efficacy in treating a patient's neurological condition
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, known mutations causing early onset Alzheimer's, and Posterior Cortical Atrophy. The monthly survey contains questions designed to identify changes in cognition, mood, physical symptoms, activities of daily living, and capture any narrative information provided by patient or caregiver.
Measured: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start31 Jul 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroEM Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049341
- Sponsor's protocol ID
- NEM-004
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The results from this study will be used to improve the design and useage of the MemorEM device and secondarily to identify neurological disorders that may respond to NeuroEM's electromagnetic treatment encouraging future sham-controlled pilot trials for those conditions. The results will be used internally by the company and patient information will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Evaluating Patient Experience With the MemorEM for Patients With Neurological Diseases
- ClinicalTrials.gov ID
- NCT07049341
- Acronym / sponsor ID
- NEM-004
- Conditions
- Alzheimer's Disease, Fronto-temporal Dementia, Parkinson Disease (PD), Cortico Basal Degeneration, Posterior Cortical Atrophy (PCA), Neurological Diseases or Conditions
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NeuroEM Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Experience Arm | Active comparator | Device: MemorEM |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemorEMThe MemorEM device delivers 915MHz electromagnetic waves to the head via 8 emitters in a cap worn on the head and powered by a control box and battery worn on the arm. | Device | Patient Experience Arm |
Primary outcome
Patient and caregiver reports on device design and use
Time frame: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.
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 will be gathered via a monthly survey. This information may help in new designs of the MemorEM and suggest ways to increase compliance for future clinical trials and eventual commercialization.
1 secondary outcome
Reports of efficacy in treating a patient's neurological condition
Time frame: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No. The results from this study will be used to improve the design and useage of the MemorEM device and secondarily to identify neurological disorders that may respond to NeuroEM's electromagnetic treatment encouraging future sham-controlled pilot trials for those conditions. The results will be used internally by the company and patient information will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MemorEM in people with Alzheimer's Disease and Fronto-temporal Dementia, run by NeuroEM Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and caregiver reports on device design and use (time frame: Surveys will be given starting a month after beginning treatment and monthly thereafter over the course of up to two years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.