Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Effects of PEMF Treatment on Patients With Mild to Moderate Alzheimer's Disease in a Randomized, Controlled Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05295615
• Other study ID #: HM003
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Herrick Medical LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Double-blind, randomized, placebo-controlled 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 be randomized to active or sham device group. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: September 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age = 50 to 85 years

2. Patients diagnosed with mild to moderate Alzheimer's Dementia defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria (McKhann et al, 2011)

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• ECHS AD Device
Pulsed electromagnetic therapy device
• ECHS Sham AD Device
Non-functioning electromagnetic therapy device

Locations

Country	Name	City	State
United States	Hackensack Medical Center	Hackensack	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Herrick Medical LLC	Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Primary	Mini-Mental Status Exam (MMSE)	Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity	Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Primary	Global Deterioration questionnaire	Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity	Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Primary	Quality of Life Scale	Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity	Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days