Study of Magnetic Fields to Treat Alzheimer's Disease
This study has been withdrawn prior to enrollment.
Information provided by:
pico-tesla Magnetic Therapies, LLC
First received: March 10, 2011
Last updated: May 27, 2011
Last verified: May 2011
To determine if low level magnetic fields can help to improve memory in patients diagnosed with Alzheimer's disease.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy of the Application of Magnetic Fields Using the Resonator for the Treatment of Alzheimer‟s Disease in Addition to Standard of Care
Primary Outcome Measures:
- Alzheimer's Disease Assessment Scale-Cog (ADAS-cog) [ Time Frame: end of treatment at 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mini-Mental Status Exam (MMSE), Neuropsychiatric Inventory Questionnaire (NPI-Q), Clinical Dementia Scale [ Time Frame: end of treatment at 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
Active Comparator: Resonator
Treatment with active Resonator device using low level magnetic fields
Treatment group vs. Placebo group
Placebo Comparator: Placebo
Inactive Resonator Device
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.
|Ages Eligible for Study:
||55 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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: NCT01313806
|Mile High Research Center
|Denver, Colorado, United States, 80218 |
|Innovative Research of West Florida
|Clearwater, Florida, United States, 33756 |
pico-tesla Magnetic Therapies, LLC
||Jack A Klapper, MD
||Mile High Research Center
||Miguel Trevino, MD
||Innovative Research of West Florida
No publications provided
||Allen S. Braswell CEO, pico-tesla Magnetic Therapies, LLC, Pico-Tesla Magnetic Therapies, LLC
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 10, 2011
||May 27, 2011
||United States: Institutional Review Board
Keywords provided by pico-tesla Magnetic Therapies, LLC:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Nervous System Diseases