Pulsed electromagnetic field treatment for Alzheimer's disease
Effects of PEMF Treatment on Patients With Mild to Moderate Alzheimer's Disease in a Controlled Pilot Study
NA · Herrick Medical LLC · NCT05295615
This study is testing a new device that uses pulsed electromagnetic fields to see if it can help people with mild to moderate Alzheimer's disease improve their thinking skills over 120 days.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | Herrick Medical LLC (industry) |
| Locations | 1 site (Hackensack, New Jersey) |
| Trial ID | NCT05295615 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effects of a pulsed electromagnetic field treatment device on patients with mild to moderate Alzheimer's disease. Participants will use the device at home for 15 minutes, three times a day, over a period of 120 days. The study aims to assess changes in cognitive function using standardized assessments, with follow-up evaluations occurring for nine months post-treatment. The approach focuses on understanding how this non-invasive treatment may influence disease progression.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older diagnosed with mild to moderate Alzheimer's disease.
Not a fit: Patients with severe Alzheimer's disease or those not meeting the eligibility criteria will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could slow the progression of cognitive decline in Alzheimer's patients.
How similar studies have performed: While this approach is relatively novel, similar studies exploring electromagnetic therapies have shown promise, though results are varied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hackensack, New Jersey
- Hackensack Medical Center — Hackensack, New Jersey, United States (RECRUITING)
Study contacts
- Study coordinator: Manisha Parulekar, MD
- Email: manisha.parulekar@hmhn.org
- Phone: 551-996-1140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease