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Transcranial Electromagnetic Treatment Against Alzheimer's Disease

NCT03927040 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-05-22

No results posted yet for this study

Summary

This is an extension of EM 1000-1 wherein subjects who participated in the original study have been given the opportunity to participate in a 4-month extension of TEMT. Seven of the eight subjects in the original EM 1000-1 agreed to participate in this study extension. The time between completion of the initial study's 2-month treatment period and the beginning of this extension study's 4-month treatment period will range from 4 months to 13 months (due to staggered start of treatment in the initial study). This extension study's primary objective is to determine the effects of a follow-up treatment period of 4-months on performance of Alzheimer's Disease (AD) subjects in the same comprehensive array of cognitive tasks they performed in the initial 2-month treatment study. Baseline cognitive performance will be compared to performance at both 2-months into treatment and at the end of the 4-month treatment period. Secondary objectives include analysis of blood and CSF for AD markers and evaluation of safety throughout the treatment period.

Conditions

  • Alzheimer Disease
  • Alzheimer Disease, Late Onset

Interventions

DEVICE

MemorEM 1000

The MemorEM 1000 device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel/battery box is worn on the upper arm and wired to specialized emitters in the head cap worn by the subject. The device provides global treatment to forebrain. For each of the 120 days of in-home treatment, a single 1-hour treatment will be administered by the subject's caregiver, who will position the device on the patient's head and monitor treatment.

Sponsors & Collaborators

  • NeuroEM Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Amanda Smith, MD · University of South Florida Health / Byrd Alzheimer's Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
63 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2020-10-05
Completion
2020-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03927040 on ClinicalTrials.gov