Alzheimer's DiseaseNCT06862557
Pulsed Electromagnetic Field Treatment With Dementia Patients
A study testing ECHS AD Device in people with Alzheimer's Disease and Lewy Body Dementia, run by Herrick Medical LLC at 1 site in United States.
Trial summary
An open label pilot study in mild to moderate AD/ADRD patients to assess the effects of treatment with ECHS AD/ADRD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Alzheimer's Disease, Lewy Body Dementia, Vascular Dementia
- What is being tested?
- ECHS AD Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Sep 2027
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline.
- 3. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity 7. Able and willing to comply with the protocol 8. If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) 10. Physical clearance for study participation as evaluated by the clinician
Who cannot join
- The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
- The patient does not have a study partner who would be available for interview
- History of epileptic seizures or epilepsy
- Has Frontotemporal Dementia
- Currently taking medication that lowers the seizure threshold, excluding blood thinners
- Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed if termination of treatment occurred at least 3 months prior to the baseline visit).
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- Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study
- Severe agitation that would interfere with study procedures
- Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
- Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of >1 week hospitalization) within 4 weeks
- Head anatomy that interferes with the fit of the treatment device
- Participation in another clinical trial within the previous 30 days
- Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
- Criteria to exclude participants from the blood draw study:
- Any condition that may significantly increase risks associated with blood draws
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Boca Raton, Florida, 334233
Magdalena Tolea, PhD, 561-869-6810, mit38@med.miami.edu
Magdelena Tolea, PhD
About this study
Official title: Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study
An open label pilot study in mild to moderate AD/ADRD patients to assess the effects of treatment with ECHS AD/ADRD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end point is the The Alzheimer's Disease Assessment Scale-Cognitive Subscale. Participants will be followed-up for 9 months post-treatment.
- Conditions
- Alzheimer's Disease, Lewy Body Dementia, Vascular Dementia
- Being tested
- ECHS AD Device
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHS AD DeviceDevice
Pulsed electromagnetic therapy device
| Study group | Role | What they receive |
|---|---|---|
| Active ECHS AD device | Experimental | Experimental intervention arm Receives: Device: ECHS AD Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.
Measured: Change between day 0, and 45, 90, 135, 180 days
Secondary outcomes (5)
Mini-Mental Status Exam (MMSE)
Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity
Measured: Change between day 0, and 45, 90, 135, 180 days
Quality of Life Scale
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Measured: Change between day 0, and 45, 90, 135, 180 days
Global Deterioration questionnaire
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Measured: Change between day 0, and 45, 90, 135, 180 days
Side-Effects Questionnaire
Self-report of side-effects
Measured: Change between day 0, and 45, 90, 135, 180 days
Clinical Dementia Rating (CDR) sum of boxes (CDR-SB)
CDR-SB assesses the severity and progression of dementia
Measured: Change between day 0, and 90, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Active treatment
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herrick Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862557
- Sponsor's protocol ID
- HM004
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06862557
- Acronym / sponsor ID
- HM004
- Conditions
- Alzheimer's Disease, Lewy Body Dementia, Vascular Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Herrick Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Mar 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.
An open label pilot study in mild to moderate AD/ADRD patients to assess the effects of treatment with ECHS AD/ADRD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end point is the The Alzheimer's Disease Assessment Scale-Cognitive Subscale. Participants will be followed-up for 9 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Active treatment
| Arm | Type | Receives |
|---|---|---|
| Active ECHS AD device | Experimental | Device: ECHS AD DeviceExperimental intervention arm |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline.
- 3. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity 7. Able and willing to comply with the protocol 8. If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) 10. Physical clearance for study participation as evaluated by the clinician
Key exclusion criteria (15 listed)
- The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
- The patient does not have a study partner who would be available for interview
- History of epileptic seizures or epilepsy
- Has Frontotemporal Dementia
- Currently taking medication that lowers the seizure threshold, excluding blood thinners
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 |
|---|---|---|
| ECHS AD DevicePulsed electromagnetic therapy device | Device | Active ECHS AD device |
Primary outcome
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: Change between day 0, and 45, 90, 135, 180 days
Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.
5 secondary outcomes
Mini-Mental Status Exam (MMSE)
Time frame: Change between day 0, and 45, 90, 135, 180 days
Quality of Life Scale
Time frame: Change between day 0, and 45, 90, 135, 180 days
Global Deterioration questionnaire
Time frame: Change between day 0, and 45, 90, 135, 180 days
Side-Effects Questionnaire
Time frame: Change between day 0, and 45, 90, 135, 180 days
Clinical Dementia Rating (CDR) sum of boxes (CDR-SB)
Time frame: Change between day 0, and 90, 180 days
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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECHS AD Device in people with Alzheimer's Disease and Lewy Body Dementia, run by Herrick Medical LLC 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 2 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?
Contact Magdalena Tolea, PhD (561-869-6810, mit38@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) (time frame: Change between day 0, and 45, 90, 135, 180 days). 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 17 Sep 2026.