Transcranial Electromagnetic Treatment (TEMT) Against Alzheimer's Disease

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID: NCT04271163
Run by: NeuroEM Therapeutics, Inc.
People needed: 6
Starts: 2020-02-10
Expected to finish: 2021-03-31
Last updated by the study team: 2020-02-17

Who can join

Age: 63 and older. Sex: any. Healthy volunteers: not accepted.

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
Patients with hypertension that is unresponsive to anti-hypertensive medications
Patients with a history of migraine headaches occurring more than once a month
Patients with a history of cancer within last 3 years (basal cell and squamous cell carcinomas will be considered on a case by case basis by investigator)
Patients chronically taking anticoagulants or anti-platelets (at discretion of PI)
Pregnant women and women who have the ability to become pregnant
Patients with compressed hair thickness of more than 5mm (which could increase distance between head antennas and the scalp).
Cardiac pacemakers
Implanted medication pumps
Intracardiac lines
Significant heart disease

Where it is running

Axiom Clinical Research of Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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