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Alzheimer's DiseasePhase 1/2NCT04271163

Transcranial Electromagnetic Treatment (TEMT) Against Alzheimer's Disease

A Phase 1/2 study testing MemorEM in people with Alzheimer's Disease, run by NeuroEM Therapeutics, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 63 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
MemorEM
Type of treatment
Medical device
How many people
6 participants
Where
1 siteUnited States
Study dates
10 Feb 2020to 31 Mar 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 63 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
MemorEM
Keywords
Alzheimer's, electromagnetic, cognition, A-beta, tau
Medical subject headings
Alzheimer Disease, Pick Disease of the Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MemorEMDevice

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (9)

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

    Blood will be analyzed for beta-amyloid and tau species via specific monoclonal antibody kits

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

  2. Adverse Event Assessment (Adverse Event Assessment)

    AEA will be the primary safety outcome measure

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

  3. Rey AVLT (Auditory Verbal Learning) score

    This is a secondary cognitive outcome to assess effects of treatment on cognition

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

  4. Digit span score

    This is a secondary cognitive outcome to assess effects of treatment on cognition

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

  5. (Mini Mental State Examination (MMSE) score

    This is a secondary cognitive outcome to assess effects of treatment on cognition; maximum (best) score is 30 and minimum (worse) score is zero

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

  6. Global Deterioration score (GDS)

    This is a secondary cognitive outcome to assess effects of treatment on cognition

    Measured: Changes from baseline GDS score at two, five, eight, and 12 months into treatment

  7. Trails A & B score

    This is a secondary cognitive outcome to assess effects of treatment on cognition

    Measured: Changes from baseline in Trails A & B scores at two, five, eight, and 12 months into treatment

  8. Clock draw score

    This is a secondary cognitive outcome to assess effects of treatment on cognition

    Measured: Changes from baseline in clock draw score at two, five, eight, and 12 months into treatment

  9. MRI Scan (acquisition only)

    This is a safety outcome to assess any brain consequences of treatment

    Measured: Change from baseline at 12 months into treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start10 Feb 2020
  3. Primary completion28 Feb 2021 (estimated)
  4. Study completion31 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-Label Pilot Study
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04271163
Sponsor's protocol ID
EM1000-2
Status last verified
Feb 2020
First submitted
11 Feb 2020
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not anticipated that Individual Participant Data (IPD) will be shared with other researchers

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MemorEM in people with Alzheimer's Disease, run by NeuroEM Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale (ADAS)-cog13 score (time frame: Changes from baseline ADAS-cog at two, five, eight, and 12 months into treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04271163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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