Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, 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,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months. Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2 Ages: 50-85 Genders: both

Official Title
-----------------
Phase 2 Study of Trans Cranial Magnetic Stimulation as Additional Therapy Patients With Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Device: TMS, H coil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 50-85. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria). Scored below 24 on the MMSE. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire. Gave their oral and written consent to participate in the trial. Exclusion criteria: An additional neurological or psychiatric disorder. Severe personality disorder. Uncontrolled hypertension. History of epilepsy, seizure, or heat convulsion. History of epilepsy or seizure in first degree relatives. History of head injury or stroke. History of metal implants in the head (except dental fillings). History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps. History of migraines in the last six months. History of drug or alcohol abuse. Inadequate communication with examiner. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it. Inability to sign a consent form.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TMS, High Frequency<br>High Frequency TMS with H coil to prefrontal cortex | Device: TMS, H coil<br>* TMS, H Coil, High/ Low Frequency<br>* Other names: TransCranial Magnetic Stimulation;|
| Active Comparator: TMS, Low Frequency<br>Low Frequency TMS to Prefrontal cortex | Device: TMS, H coil<br>* TMS, H Coil, High/ Low Frequency<br>* Other names: TransCranial Magnetic Stimulation;|
| Placebo Comparator: Sham Stimulation<br>Sham TMS with H Coil on Prefrontal Cortex | Device: TMS, H coil<br>* TMS, H Coil, High/ Low Frequency<br>* Other names: TransCranial Magnetic Stimulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive functioning score by ADAS-COG |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global advancement score by CGI-C |  | 4 months | 
| Frontal lobe functioning score by FAB |  | 4 months | 
| Daily activity score by ADL |  | 4 months |