If the individual remains interested in participating in the study and has voluntarily signed the informed consent form, he or she will undergo the study inclusion/exclusion criteria evaluation as follows. The inclusion/exclusion criteria evaluation will be conducted by one of the study physicians (including the Principal Investigator) and/or study LPN.
Inclusion Criteria
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
The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the
Magneceutical®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.