Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for Alzheimer Patients

Study Overview
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Brief Summary
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Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features, such as atrophy, which is a late feature in the progression of the disease. Therefore, developing new approaches for early and specific recognition of Alzheimer disease at the prodromal stages is of crucial importance. In the present study the investigators would like 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 Alzheimer's disease (AD) patients. A number of in vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects of neuroanatomy, chemistry, physiology, and pathology, hold promise.

Official Title
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Testing the Effects of TMS Stimulation and Cognitive Training for Alzheimer Patients: A Pilot Study

Conditions
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Alzheimer Disease, Early Onset

Intervention / Treatment
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* Device: TMS stimulation
* Device: Sham comparator
* Behavioral: Cognitive training


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 15 to 26 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 (transportation for the patient to and from the investigator's clinic, answering questions regarding the patient's condition and assuming responsibility for medication) Written informed consent by patient or legally responsible caregiver. Able to undergo MRI scanning sessions (e.g., prior to the onset of the study, upon the attainment of the primary end-point and at the end of the study). Commitment to participation in six-to eighteen weeks of the trial regimen consisting of approximately1 hour TMS stimulation and cognitive training daily treatment of five days a week - six to eighteen weeks (and up to two treatments a day in case the Third TMS stimulation and cognitive training Treatment protocol if necessary). 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; Clinically significant abnormal laboratory findings which have not been approved by the Project Director;

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group (#1)<br> | Device: TMS stimulation<br>* TMS stimulation and cognitive training<br>Behavioral: Cognitive training<br>* TMS stimulation and cognitive training<br>|
| Sham Comparator: Control group (#2)<br> | Device: Sham comparator<br>* Sham comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be established by paucity of related adverse events. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer, TMS, cognitive training