Recruiting

Magnetic Fields

Sponsor:

pico-tesla Magnetic Therapies, LLC

Code:

NCT01195389

Conditions

Alzheimer's Dementia

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Resonator

Study Details

Brief summary:

The purpose of this study is to determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's dementia.

Conditions

Alzheimer's Dementia

Study ID

NCT01195389

Start date

Dec, 2010

Status verified date

Jun, 2011

Completion date

Oct, 2011

Anticipated

Primary completion date

Oct, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion 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:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Resonator

Treatment with active Resonator device using low level magnetic fields

placebo comparator: Placebo treatment

Interventions

Resonator

Treatment group vs. Placebo group

Primary outcome measure

  • Alzheimer's Disease Assessment Scale-Cog (ADAS-cog) [ Time Frame: end of treatment at 12 weeks ]

Central Contacts and Locations

Central contacts

Amanda Smith, MD

813-974-4355

Locations

USF Health Byrd Alzheimer's Institute

Recruiting

Tampa, Florida, United States, 33613

Contacts

Amanda Smith, MD

813-974-4355

Principal Investigator:

Amanda Smith, MD

More Information

Sponsor

pico-tesla Magnetic Therapies, LLC

Last update posted

Jul 8, 2011

Last verified

Jun, 2011

Keywords

  • dementia
  • memory loss
  • cognitive decline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by pico-tesla Magnetic Therapies, LLC on 2011-07-08.