Effect of NeuroAD on Alzheimer Patients

Study Overview
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Brief Summary
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Non-invasive stimulation of the brain using magnetic and cognitive stimulation by computer for the treatment of Alzheimer patients.

Detailed Description
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Synchronized TMS and cognitive training for the treatment of mild to moderate Alzheimer's patients. Treatment is delivered 5 days a week, for 6 weeks, visit is about an hour long. Evaluation is by neuropsychological evaluation at 6 weeks.

Official Title
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Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Device: NeuroAD
* Device: Sham device


Participation Criteria
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Eligibility Criteria
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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 Adas-cog above 17 Physically acceptable for the study as confirmed by medical history and exam. Spouse, family member or professional caregiver agree and capable of taking care and be responsible for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication) Agreement to participate in approximately 14 weeks during the study. Normal or corrected to normal ability to see and to hear. Korean as primary language 8th grade education minimum Exclusion Criteria: CDR 0 or 3 Severe agitation; Mental retardation; Patient lacking capacity to consent to study participation Unstable medical condition; Use of benzodiazepines or barbiturates 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; History of Epileptic Seizures or Epilepsy; Contraindication for performing MRI scanning; Contraindication for receiving TMS treatment according to a TMS questionnaire; Pregnant women, and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study. Patients with personal history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, or multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness. Patients with depression, bipolar disorder or psychotic disorders or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study Alcoholism or drug addiction as defined by DSM-IV within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation Patients treated with cholinesterase inhibitors, or memantine or Ginko-biloba will be allowed to participate, if the treatment has started at least 6 months previous to recruitment. The patients should keep their dose of medication during the whole trial as prior to study begin. Patients with metal in the head, except the mouth (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) Patients with increased intracranial pressure Cardiac pacemakers Implanted neurostimulators Implanted medication pumps Intracardiac lines Significant heart disease Currently taking medication that lower the seizure threshold Significant sleep deprivation and alcoholism

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NeuroAD<br>Treatment by the NeuroAD device, real treatment by synchronized TMS+cognitive training | Device: NeuroAD<br>* synchronized TMS+COGNITIVE TRAINING<br>* Other names: NICE;|
| Sham Comparator: Sham NeuroAD<br>Sham TMS+cog, has the same sound and appearance, patients come for the same number of treatments and are exposed to the same procedure. | Device: Sham device<br>* Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.<br>* Other names: Control device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-Cog | Alzheimer's disease assessment scale - cognitive test | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, TMS, NeuroAd, cognitive training, ADAS-Cog