Effects of a NeuroAD System, for the Treatment of Alzheimer Disease

Study Overview
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Brief Summary
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To evaluate the long-term efficacy of the NeuroAD system

Detailed Description
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To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function

Official Title
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Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Device: NeuroAD
* Device: Sham TMS+Cog


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male or female age 60-90 years Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria MMSE score 18 to 26 Physical clearance for study participation as evaluated by the clinician Spouse, family member or professional caregiver agree and capable of taking care for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication) Informed consent by the patient or by legally authorized person if appointed Main Exclusion Criteria: CDR 0, 0.5 or 3 Severe agitation Mental retardation History of Epileptic Seizures or Epilepsy Contraindication for performing MRI scanning Contraindication for receiving TMS treatment according to a TMS questionnaire Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth Cardiac pacemakers Implanted medication pumps Intracardiac lines Significant heart disease Currently taking medication that lower the seizure threshold

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NeuroAD<br>NeuroAd Treatment, synchronized TMS and cognitive training stimulation | Device: NeuroAD<br>* Synchronized TMS and cognitive stimulation to 6 brain areas.<br>* Other names: NICE;|
| Sham Comparator: Sham TMS+Cog<br>Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises. Patients come for the same number of sessions, delivers no real stimulation or cognitive training. | Device: Sham TMS+Cog<br>* Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Change from Baseline to 3 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Change from Baseline to week 7 in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change | 7 weeks | 
| Efficacy | Change from Baseline to 6 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change | 6 Months | 
| Efficacy | Change from Baseline to 9 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change | 9 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, Cognitive Stimulation, NeuroAD