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WithdrawnNCT01313806Updated May 30, 2011

Study of Magnetic Fields to Treat Alzheimer's Disease

An interventional study of Resonator and Placebo in Alzheimer's Disease, sponsored by pico-tesla Magnetic Therapies, LLC. Withdrawn at 2 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2011-05-30.

Sponsored by pico-tesla Magnetic Therapies, LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study summary

To determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's disease.

Read the detailed description

The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator may improve cognitive functioning and memory in individuals with a diagnosis of Alzheimer"s dementia, as an adjunctive therapy to standard of care.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • dementia
  • memory loss
  • cognitive decline
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

pico-tesla Magnetic Therapies, LLC is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

To be considered eligible for participation in this clinical study, a subject must satisfy each of the following "Inclusive Conditions" criteria.

  • Current diagnosis of Alzheimer's Disease appropriately documented by the patients physician and/or neurologist
  • Documentation verifying that other generally recognized causes of dementia have been ruled out by prior physician evaluations
  • Mild to Moderate Dementia, as evidenced by a score of not less than 12 nor greater than 26 on the Mini Mental Status Exam (MMSE).
  • Subject is ambulatory
  • A Study Partner who can attend all study visits with the subject. Study Partner being defined as an adult who has at least 10 hours/week of contact with the subject, and can accompany the subject to all testing and treatment study visits.
  • Stable "anti-dementia" medication regimen without significant side effects for at least 3 months, and on stable medication (unrelated to anti-dementia) without significant side effects for at least 1 month; willingness and ability to maintain the stable medication regimen throughout the course of the study.
  • Willingness and ability to present to the testing center for all study evaluations
  • Willingness and ability to present to the treatment center for all study treatments (exposure to the Resonator™)
  • Willingness to maintain stable diet and activity regimen for the duration of the study.
  • Willing and able to abstain from partaking in any non-essential (not physician ordered) existing or new treatments to improve cognition and mental functioning
  • Willing and able to abstain from any medications that could affect cognition and mental functioning during the course of the study
  • Male or female.
  • Any ethnic background.
  • Age 55 and older.

Exclusion Criteria A subject will be considered ineligible for participation in this clinical study if he or she satisfies any one or more of the following exclusive conditions criteria.

  • Change in anti-dementia medical regimen within 3 months prior to initiation of study.
  • Confirmed diagnosis other non-Alzheimer's type of dementia
  • Significant neurologic or psychiatric illness other than Alzheimer's disease
  • Unstable cardiac disease, such as any history of cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation, or irregular atrial-ventricular conduction time), or any incidences of congestive heart failure, or myocardial infarction, within the last six months.
  • Previous surgical interventions involving prosthetics or implants comprised of ferrous metals, or pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
  • Reported consumption of more than 14 alcoholic drinks per week.
  • Uncontrolled hypertension.
  • Uncontrolled atrial fibrillation or other uncontrolled arrhythmias, e.g. tachycardia, bradycardia.
  • Uncontrolled seizure disorder.
  • History of seizures or usage of anti-seizure medications that, in the opinion of the investigator, participation in this trial would represent a risk to the subject.
  • Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subject's health or ability to complete the entire study, in the opinion of the investigator.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Resonator

    Treatment with active Resonator device using low level magnetic fields

    Device: Resonator

  • Placebo comparator
    Placebo

    Device: Placebo

Interventions

  • DeviceResonator

    Treatment group vs. Placebo group

  • DevicePlacebo

    Inactive Resonator Device

06

What researchers measure

Primary outcomes

  1. Alzheimer's Disease Assessment Scale-Cog (ADAS-cog)

    Time frame: end of treatment at 12 weeks

Secondary outcomes

  1. Mini-Mental Status Exam (MMSE), Neuropsychiatric Inventory Questionnaire (NPI-Q), Clinical Dementia Scale

    Time frame: end of treatment at 12 weeks

07

Study locations

2 sites
  • Mile High Research Center
    Denver, Colorado 80218, United States
  • Innovative Research of West Florida
    Clearwater, Florida 33756, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01313806
Lead sponsor
pico-tesla Magnetic Therapies, LLC
First posted
Mar 14, 2011
Start date
Sep 2011
Primary completion
Sep 2012 (estimated)
Completion
Sep 2012 (estimated)
Last update
May 30, 2011

Study contacts

Jack A Klapper, MD
principal investigator · Mile High Research Center
Miguel Trevino, MD
principal investigator · Innovative Research of West Florida

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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