Alzheimer's Clinical Trial Protocol - Pico-Tesla Magnetic Therapies, LLC

		Alzheimer's Clinical Study Information The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease. Overview Device User Interface Safety and Risks FDA Clearance Overview The Resonator™ Device Compared to Other Magnetic Devices and Parkinson’s Disease Therapies The Device Versus MRI (Magnetic Resonance Imaging) The Device Versus TMS and rTMS The Device Versus Other Parkinson’s Disease Therapies Overview Jacobson Resonance™

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Study Contact Information
Sponsor
Monitor
Principal Investigator
Study Consultant
Test Sites
Treatment Site
Institutional Review Board (IRB)

Device Information
Device Description
Signal Generator
Helmholtz Coils
Regulatory Status
Determination of Device Safety
IRB Determination of Device Safety

Study Information
Study Indication & Rationale
Study Treatment Modality: EM Stimulation
Theory of Mechanism of Operation (Part 1)
Theory of Mechanism of Operation (Part 2)
Theory of Mechanism of Operation (Part 3)

Study Design
Purpose
Study Objectives
Procedure Groups
Single-Blind Design
Randomization Procedure
Subjects
Inclusion Criteria
Exclusion Criteria
Measurements & Procedures

Study Procedures
Screening Visit
Treatment Administration Phase (Part 1)
Treatment Administration Phase (Part 2)
Titration Description
Group A Sample Approach
Group 2 Sample Approach
Post-Treatment Phase (Week 12)
Post-Treatment Phase (Months 1 & 2)
Safety Evaluation
Privacy and Confidentiality
Monitoring of the Clinical Study
Statistical Analysis Plan
Informed Consent
Case Report Forms
Research Personnel Training & Certification

Subjects

This study will include up to 30 individuals who satisfy the study qualification criteria. Subjects will be randomized into one of the three study procedure groups. All Resonator procedure administrations will be done at a single treatment site location under one Principal Investigator.

Recruitment
Subjects will be recruited through physician referrals, Alzheimer’s disease support groups, and advertising in local publications or at health events. Additionally, the study will be listed on the USF Clinical Trials website. Flyers and brochures have been created as a recruitment tools. A copy of these materials will be submitted to the IRB for approval. Additional recruitment wording (which may be used for publications in local newsletters or newspaper) can be found in the Appendix B.

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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.