Safety and Efficacy Study of Magnetic Fields to Treat Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by pico-tesla Magnetic Therapies, LLC.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
pico-tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier:
NCT01195389
First received: September 1, 2010
Last updated: July 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Alzheimer's Dementia
Device: Resonator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Efficacy of the Application of Magnetic Fields Using the Resonator for the Treatment of Alzheimer's Disease in Addition to Standard of Care

Resource links provided by NLM:


Further study details as provided by pico-tesla Magnetic Therapies, LLC:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-Cog (ADAS-cog) [ Time Frame: end of treatment at 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Resonator
Treatment with active Resonator device using low level magnetic fields
Device: Resonator
Treatment group vs. Placebo group
Placebo Comparator: Placebo treatment Device: Resonator
Treatment group vs. Placebo group

Detailed Description:

The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator result in statistically significant improvements in cognitive functioning and memory in patients with a diagnosis of Alzheimer's dementia.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195389

Contacts
Contact: Amanda Smith, MD 813-974-4355

Locations
United States, Florida
USF Health Byrd Alzheimer's Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Amanda Smith, MD    813-974-4355      
Principal Investigator: Amanda Smith, MD         
Sponsors and Collaborators
pico-tesla Magnetic Therapies, LLC
Investigators
Principal Investigator: Amanda Smith, MD University South Florida Health Byrd Alzheimer's Institute
  More Information

No publications provided

Responsible Party: Allen S. Braswell Jr. CEO, Pico-Tesla Magnetic Therapies, LLC
ClinicalTrials.gov Identifier: NCT01195389     History of Changes
Other Study ID Numbers: USF #6178-P67865
Study First Received: September 1, 2010
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by pico-tesla Magnetic Therapies, LLC:
dementia
memory loss
cognitive decline

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014