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Effect of NeuroAD on Cognitive Function in Alzheimer's Disease

Completed

This clinical trial will test the effect of NeuroAD, a noninvasive device that delivers magnetic stimulation to the brain, on cognition in people with mild to moderate Alzheimer's disease. 

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 90 Years Both No
October 2013
December 2015
120

  • Diagnosis of mild to moderate Alzheimer's disease, according to DSM-IV criteria
  • Mini-Mental State Examination score of 18-26; ADAS-Cog score above 17
  • Physical clearance for study participation as evaluated by the clinician
  • Spouse, family member, or professional caregiver who can be responsible for the participant during the study (answering questions regarding the person's condition and assuming responsibility for medication)
  • Normal to near-normal vision and hearing with correction as needed (corrective lenses, hearing aid)
  • Fluent in English or Hebrew
  • Minimum 8th grade education
  • Alzheimer's medications allowed if taken for at least 3 months and on stable dose for at least 60 days (cholinesterase inhibitors, memantine or ginkgo biloba)

  • Clinical Dementia Rating of 0, 0.5, or 3
  • Severe agitation
  • Mental retardation; lack of capacity to consent to study participation
  • Unstable medical condition; significant heart disease; history of any medical disorder or neurological/psychiatric disorder (other than Alzheimer's), including epilepsy, stroke, brain lesions, vitamin B12 deficiency, abnormal thyroid function, cerebrovascular condition, other neurodegenerative disease, head trauma, multiple sclerosis
  • Previous neurosurgery or head trauma that resulted in loss of consciousness
  • Use of benzodiazepines or barbiturates 2 weeks prior to screening
  • Pharmacological immunosuppression
  • Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment
  • History of epileptic seizures or epilepsy
  • Contraindication for MRI scan or transcranial magnetic stimulation treatment
  • Pregnancy or the ability to become pregnant unless using an acceptable method of contraception during the study
  • Current or past depression, bipolar disorder, psychotic disorder, or any other neurological or psychiatric condition that could interfere with the study
  • Alcoholism or drug addiction within the last 5 years, as defined by DSM-IV (addicted more than 1 year and/or in remission less than 3 years) or severe sleep deprivation
  • Metal implants in the head, such as cochlear implants, implanted brain stimulators, or aneurism clips, with the exception of metal implants in the mouth
  • Signs or symptoms of increased intracranial pressure, as determined by neurological exam
  • Cardiac pacemaker; implanted medication pump; intracardiac line
  • Taking medication that could lower the seizure threshold
  • Previous treatment with transcranial magnetic stimulation (TMS)

This clinical trial will test NeuroAD, a noninvasive system of transcranial magnetic stimulation and cognitive training, as a way to improve cognitive function in people with mild to moderate Alzheimer's disease. Potential participants will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization to either the experimental treatment group or the placebo group, which will receive treatment with a sham device. Individuals will visit the clinic five times a week for 6 weeks, approximately an hour every day for treatment, then return for a follow-up visit.

Name City State Zip Status Primary Contact
Banner Sun Health Research Institute
Sun City Arizona 85351

ATP Clinical Research, Inc.
Costa Mesa California 92626

Miami Jewish Health Systems
Miami Florida 33137

Roskamp Institute Clinic
Sarasota Florida 34243

Palm Beach Neurology and Premiere Research Institute
West Palm Beach Florida 33407

Beth Israel Deaconess Medical Center
Boston Massachusetts 02215

Cleveland Clinic Lou Ruvo Brain Center
Las Vegas Nevada 89106

NYU Langone Medical Center
New York New York 10016

Cleveland Clinic Center for Brain Health Lakewood Hospital
Cleveland Ohio 44107

Neuronix Ltd.

Name Role Affiliation
Charlie Bernick, MD Principal Investigator Lou Ruvo Brain Center

Name Phone Email
Moran Ploznik +972-4-9038603 moran@neuronixmedical.com

NCT01825330

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