CompletedNot Applicable

Transcranial Electromagnetic Treatment Against Alzheimer's Disease

United States7 participantsStarted 2019-04-15

Plain-language 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.

Who can participate

Age range63 Years – 84 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. * MMSE score 16 to 26 * Physical clearance for study participation as evaluated by the clinician. * Caregiver (spouse, family member, etc.) who agrees to and is capable of taking care and being responsible for the participation of the patient in the study (keeping a diary of health measures they collect on the patient at home, logging the patient's condition daily, and assuming responsibility for administering daily in-home treatment). Caregiver to have non-impaired mental abilities and normal motor skills, as determined by the investigators at screening. The definition of caregivers for this study is adults providing unpaid care to relatives or friends to help them take care of themselves in such activities as managing finances, shopping, preparing meals, and going to doctor appointments. * Agreement to participate in approximately 18 weeks during the study. * Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid). * Fluent in English * Minimum of 8th grade education * Head circumference between 53 - 60 cm (to minimize variability in head antenna locations) * If medicated for AD, then use of cholinesterase inhibitors and/or memantine for at least 3 months, on stable …

What they're measuring

ADAS-cog score

Timeframe: Change from baseline ADAS-cog at two and four months into treatment

Trial details

NCT IDNCT03927040

SponsorNeuroEM Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-05