TMS Stimulation and Cognitive Training in Alzheimer Patients

Study Overview
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Brief Summary
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The aim of this study is to examine if combined treatment with TMS and cognitive training (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral symptomatology of mild to moderate Alzheimer's disease (AD) patients.

Detailed Description
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The current available pharmaceutical treatment for Alzheimer Disease (AD) is only partially and temporary effective. Therefore, new approaches are needed. rTMS is a non-invasive technique which generates a small electric current that induces a modulation in cortical excitability. In addition, cognitive training was suggested to improve cognitive functions in Alzheimer patients. In this study we intend to treat mild to moderate AD patients with rTMS interlaced with cognitive training (rTMS- COG). Patients with probable AD will be treated with rTMS-COG daily for 6 weeks followed by maintenance sessions for additional 3 months.

Official Title
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Effects of a Combined TMS Stimulation and Cognitive Training in Alzheimer Patients: a Single-center, Randomized, Double-blind, Placebo-controlled Study

Conditions
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Alzheimer Disease, Mild to Moderate

Intervention / Treatment
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* Device: Sham-NICE-System
* Device: NICE-System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 55-85 years Patients diagnosed with early or moderate stage of Alzheimer's disease, according to the DSM-IV criteria. MMSE score 18 to 24 Global Dementia rating 1 or 2 Physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and EKG Spouse, family member or professional caregiver agree and capable of taking care and responsibility for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication) Written informed consent by both patient and legally responsible caregiver. Able to undergo MRI scan and EEG recordings prior to the onset of the study. Agreement to participate in up to 9 months the study. Right handed Hebrew or Russian as mother tongue and/or ability to read and understand the inform consent form (ICF), and the Patient Information document in Hebrew or Russian. Exclusion Criteria: Severe agitation; Mental retardation; Unstable medical condition; Use of benzodiazepines or other hypnotics during the study and preceding two weeks; Pharmacological immunosuppression; Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment; Alcoholism; History of Epileptic Seizures or Epilepsy; Contraindication for performing MRI scanning; Contraindication for receiving TMS treatment according to a TMS questionnaire; Clinically significant abnormal laboratory findings which have not been approved by the Principle Investigator; Patients treated with cholinesterase inhibitors, or memantine or ginko-biloba will be allowed to participate, if the treatment has started at least 2 months previous to recruited.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: NICE-System NeuroAD<br>Treatment Group | Device: NICE-System<br>* TMS combined with cognitive training<br>|
| Sham Comparator: Sham-TMS<br>Control Group | Device: Sham-NICE-System<br>* sham TMS and sham cognitive training<br>* Other names: NICE-System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A significant improvement and/or improvement of at least 2 points on ADAS-COG of the Treatment Group in comparison with the Placebo Group after 6 weeks of treatment. |  | pre-treatment, 6, and 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile: rate of device and/or procedure related adverse events. |  | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Disease, Cognitive Training, Cortical Reorganization, Brain Plasticity