Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

Detailed Description
-----------------
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17). Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm. Ages: 50-80 Genders: both

Official Title
-----------------
Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Device: 1Hz TMS with H2 coil
* Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex
* Device: SHAM TMS with H2 coil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent will be obtained diagnostic evidence of probable AD consistent with DSM IV stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening stable dose treatment with other drugs MMSE <25 Exclusion Criteria: Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD Patients who are unwilling or unable to fulfill the requirements of the study Severe personality disorder Malignant or untreated Hypertension History of Epilepsy History of Head trauma Metal implant in head, cardiac pacemaker, medical pump Drug or alcohol addiction Involvement in any other clinical trial during the preceding 3 month Patient who are unwilling or unable to give Informed Consent

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>15 patients in group 1 will be treated with 1Hz frequency | Device: 1Hz TMS with H2 coil<br>* 1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex<br>|
| Active Comparator: 2<br>15 patients in group 2 will be treated with 1Hz frequency 10Hz | Device: 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex<br>* 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex<br>* Other names: 10Hz TMS with H2 coil;|
| Sham Comparator: 3<br>15 patients in group 3 will be treated with SHAM (1Hz/10Hz) | Device: SHAM TMS with H2 coil<br>* SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-COG |  | Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory. |  | Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TMS AD H2 coil