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Transcranial Electromagnetic Treatment (TEMT) Against Alzheimer's Disease

NCT04271163 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-02-17

No results posted yet for this study

Summary

This is a second extension of EM 1000-1 wherein mild/moderate AD subjects who participated in the original study have completed participation in a first extension of 4-months. Most of the eight subjects in the original EM 1000-1 and first extension agreed to participate in this second extension study. The time between completion of the first extension and the second extension is 4 months. This second extension study;'s primary objective is to determine the long-term safety and efficacy of 12 months of daily treatment on performance of these AD subjects in the same comprehensive array of cognitive tasks as they performed in the initial 2-month study and 4-month first extension.Secondary objectives include analysis of blood for AD markers and evaluation of safety throughout the treatment period. Upon completion of this 12-month extension, the period between initial treatment and final treatment will be 2-3 years.

Conditions

Interventions

DEVICE

MemorEM

The MemorEM device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range to the entire forebrain, 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. Everyday for the 12M treatment period, the subject's caregiver will administer one or two 1-hour treatments (two daily treatments during the first 2M period).

Sponsors & Collaborators

  • Axiom Clinical Research of Florida

    collaborator UNKNOWN

  • MegaNano Biotech

    collaborator UNKNOWN

  • Invicro, Boston

    collaborator UNKNOWN

  • Left Coast Engineering

    collaborator UNKNOWN

  • NeuroEM Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
63 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2021-02-28
Completion
2021-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04271163 on ClinicalTrials.gov