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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05295615
Other study ID # HM003
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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