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New treatment option for Alzheimer's Disease
Official title Pulsed Electromagnetic Field Treatment With Dementia Patients
ClinicalTrials.gov ID: NCT06862557
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 100
You may be able to join if
- 1\. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia -...
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
- 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)...
- 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).
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boca Raton, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boca Raton, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.