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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 100
Healthy Volunteers: f
View:

• Age ≥ 50 years

• Patients diagnosed with mild to moderate Alzheimer's Dementia defi

• At least an eighth grade of educational achievement

• If female, post-menopausal.

• MMSE score between 16 and 26

• Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity

• Able and willing to comply with the protocol

• 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)

• 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)

⁃ Physical clearance for study participation as evaluated by the clinician

Locations
United States
New Jersey
Hackensack Medical Center
RECRUITING
Hackensack
Contact Information
Primary
Manisha Parulekar, MD
manisha.parulekar@hmhn.org
551-996-1140
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 40
Treatments
Experimental: Active ECHS AD device
Experimental intervention arm
Related Therapeutic Areas
Sponsors
Leads: Herrick Medical LLC
Collaborators: Hackensack Meridian Health

This content was sourced from clinicaltrials.gov