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

Post Treatment

Week 12 – Immediate Post Treatment Evaluation
At treatment phase endpoint (12 weeks), subjects will return to the testing site (USF) for an evaluation visit immediately post-treatment. This visit does not have to be done on the same day as the last treatment, but will ideally be done within one week. The following procedures and assessments will be conducted by the Principal Investigator, psychometrician and/or cognitive rater:

Medical Measurements

Height
Weight
Blood pressure

Cognitive Assessments and Subject/Study Partner Interviews

Alzheimer’s Disease Assessment Scale-Cog (ADAS-cog)
Mini-Mental state examination (MMSE)
Neuropsychiatric Inventory Questionnaire (NPI)
Clinical Dementia Rating Scale (CDR)
Modified Activities of Daily Living (ADL) Inventory

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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.