NCT05295615 Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease
| NCT ID | NCT05295615 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Herrick Medical LLC |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-05-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
An open label pilot study in mild to moderate AD patients to assess the effects of treatment with ECHS AD 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 points are the The Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Mini-Mental State Exam. Participants will be followed-up for 9 months post-treatment.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 50 years 2. Patients diagnosed with mild to moderate Alzheimer's Dementia defi 3. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 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) 9. Spouse, family member or professional caregiver agree and are capable of taking care of the participation of the patient in the study (answering questions regarding the patient's condition, assuming responsibility for medication, and applying and supervising the daily PEMF treatments) 10. Physical clearance for study participation as evaluated by the clinician Exclusion Criteria: 1. The patient lacks capacity to consent to study participation and no surrogate is available to provide consent 2. History of epileptic seizures or epilepsy 3. Currently taking medication that lowers the seizure threshold 4. 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 5. Severe agitation that would interfere with study procedures 6. 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 7. 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 8. Head anatomy that interferes with the fit of the treatment device 9. Participation in another clinical trial within the previous 30 days 10. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05295615 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 100 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05295615 currently recruiting?
Yes, NCT05295615 is actively recruiting participants. Contact the research team at manisha.parulekar@hmhn.org for enrollment information.
Where is the NCT05295615 trial being conducted?
This trial is being conducted at Hackensack, United States.
Who is sponsoring the NCT05295615 clinical trial?
NCT05295615 is sponsored by Herrick Medical LLC. The trial plans to enroll 40 participants.
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