Transcranial Electromagnetic Treatment (TEMT) Against Alzheimer's Disease

NCT04271163 | Unknown Phase 1

• 1 other identifier: EM1000-2
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Alzheimer's Disease

Keywords

Alzheimer's, electromagnetic, cognition, A-beta, tau

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale (ADAS)-cog13 score

  ADAS-cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's treatment-based clinical trials. Upper limit is 85 (poor performance) and lower limit is zero (best performance)

  Changes from baseline ADAS-cog at two, five, eight, and 12 months into treatment

Secondary Outcomes (9)

• Blood (plasma) levels of beta-amyloid1-40 and 1-42, total tau (t-tau), and phospho-tau (p-tau)

  Changes from baseline at two, five, eight, and 12 months into treatment

• Adverse Event Assessment (Adverse Event Assessment)

  Change from baseline Adverse Event Assessment at two, five, eight, and 12 months into treatment.

• Rey AVLT (Auditory Verbal Learning) score

  Changes from baseline Rey AVLT score at two, five, eight, and 12 months into treatment

• Digit span score

  Changes from baseline Digit span score at two, five, eight, and 12 months into treatment

• (Mini Mental State Examination (MMSE) score

  Changes from baseline MMSE score at two, five, eight, and 12 months into treatment

Interventions

MemorEM DEVICE

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).

Eligibility Criteria

• Age: 63 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 63+ years
• Patients diagnosed with mild or moderate stage of Alzheimer's Disease at the beginning of the original treatment study, 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 : By the end of Extension Study I, all subjects except for one had MMSE scores above 16.
• 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 54 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 dose for at least 60 days prior to screening, and maintenance on that dose for the period of this study.
• All other non-AD medications must be stable for a period of 4 weeks prior to screening

You may not qualify if:

• Severe agitation
• Mental retardation
• Unstable medical condition
• Use of benzodiazepines or barbiturates 2 weeks prior to screening
• Pharmacological immunosuppression
• Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment and no history of immunotherapy research participation
• History of Epileptic Seizures or Epilepsy
• Patients with major depression (not controlled with medication), bipolar disorder or psychotic disorders or any other neurological or psychiatric condition (whether now or in the past). The investigator will obtain this information from available patient medical records, history provided by the patient and caregiver, interview, and neurological exam.
• Alcoholism or drug addiction as defined by (Diagnostic and Statistic Manual of Mental Disorders (DSM)-IV within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
• Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) with the exception of metal implants in mouth
• Patients with vitamin B12 deficiency, abnormal thyroid function, or personal history of either any clinically defined medical disorder or any clinically defined neurological/psychiatric disorder (other than AD), including (but not limited to):, stroke, brain lesions, , cerebrovascular condition, other neurodegenerative disease, significant head trauma (loss of consciousness greater than half an hour, or related anterograde amnesia), multiple sclerosis; or personal history of previous neurosurgery or brain radiation
• Patients with any signs or symptoms of increased intracranial pressure, as determined in a neurological exam.
• Patients with demonstrated brain micro-hemorrhages (more than 5) at screening
• Patients with a score of 4 or higher on the Hachinski Test
• Patients with a score of 2 or less on the Global Deterioration Scale

Sponsors & Collaborators

• NeuroEM Therapeutics, Inc.: lead
• Axiom Clinical Research of Florida: collaborator
• MegaNano Biotech: collaborator
• Invicro, Boston: collaborator
• Left Coast Engineering: collaborator

Study Sites (1)

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Pick Disease of the Brain

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label Pilot Study

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: February 10, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 31, 2021
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)