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

NCT01195389 | Unknown DMC

• 1 other identifier: USF #6178-P67865
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

dementia; memory loss; cognitive decline

Outcome Measures

Primary Outcomes (1)

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

  end of treatment at 12 weeks

Study Arms (2)

Resonator

ACTIVE COMPARATOR

Treatment with active Resonator device using low level magnetic fields

Device: Resonator

Placebo treatment

PLACEBO COMPARATOR

Device: Resonator

Interventions

Resonator DEVICE

Treatment group vs. Placebo group

Placebo treatment; Resonator

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• pico-tesla Magnetic Therapies, LLC: lead

Study Sites (1)

USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Memory Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Study Officials

• Amanda Smith, MD

  University South Florida Health Byrd Alzheimer's Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Smith, MD

CONTACT

813-974-4355

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 6, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 8, 2011

Record last verified: 2011-06

Locations

US (1)