Study of Magnetic Fields to Treat Alzheimer's Disease

NCT01313806 | Withdrawn DMC

• 1 other identifier: WIRB 1123661
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Alzheimer's Disease

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

Secondary Outcomes (1)

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

  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

PLACEBO COMPARATOR

Device: Placebo

Interventions

Resonator DEVICE

Treatment group vs. Placebo group

Resonator

Placebo DEVICE

Inactive Resonator Device

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

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 (2)

Mile High Research Center

Denver, Colorado, 80218, United States

Location

Innovative Research of West Florida

Clearwater, Florida, 33756, United States

Location

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

• Jack A Klapper, MD

  Mile High Research Center

  PRINCIPAL INVESTIGATOR

• Miguel Trevino, MD

  Innovative Research of West Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 14, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 30, 2011

Record last verified: 2011-05

Locations

US (2)