Clinical trial NCT05295615: Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease
Official title: Effects of PEMF Treatment on Patients With Mild to Moderate Alzheimer's Disease in a Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Herrick Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: Hackensack Meridian Health
First posted: 2022-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Active treatment
Primary purpose: TREATMENT

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

Primary outcomes:
measure: The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
timeFrame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
measure: Mini-Mental Status Exam (MMSE)
timeFrame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
measure: Global Deterioration questionnaire
timeFrame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
measure: Quality of Life Scale
timeFrame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
Study officials:
References: