Transcranial Electromagnetic Treatment (TEMT) Against Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title: A Phase I Study to Evaluate the Safety and Efficacy of Transcranial Electromagnetic Treatment (TEMT) for the Treatment of Alzheimer's Disease: Extension Study II

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The present study is an Open-Label within-patient (single arm) second extension study of the Open-Label 2-month initial study (EM1000-1) and 4M first extension study, wherein most of the original eight AD subjects agree to participate. This present second extension study is intended to continue evaluation of the safety and efficacy of daily Transcranial Electromagnetic Treatment (TEMT) in patients with mild-to-moderate AD for an additional 12 month period, such that the interval between the initial day of treatment and final day of treatment will be 2-3 years.There will be a total of six clinical visits: pre-baseline, baseline, 2-, 5-, 8-, and 12-months. This second extension study will utilize the same MemorEM devices (designated as NSR and not Food and Drug Administration-regulated) as in the first extension studies, but will involve twice daily treatment for the first two months, followed by once-daily treatment thereafter.

Expected Results: The investigators expect that the additional 12 months of daily TEMT will not present any significant side effects or safety issues, as was the case for the initial study and first extension study. The investigators further expect that cognitive measures will be stable and/or improve by the end of the 12M treatment period. In addition, changes in blood/cerebrospinal fluid levels of various beta-amyloid and tau species are anticipated to reflect the primary mechanism of TEMT action -- disaggregation of both A-beta and tau oligomers. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT04271163
• Study type: Interventional
• Source: NeuroEM Therapeutics, Inc.
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 10, 2020
• Completion date: March 31, 2021