Alzheimer's Disease Education and Referral Center

Effect of NeuroAD on Cognitive Function in Alzheimer's Disease

Effect of NeuroAD on Cognitive Function in Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

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. 

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
60 Years
90 Years
Both
No
Inclusion Criteria: 
    • 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)
Exclusion Criteria: 
    • 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)
Detailed Description: 

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.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Recruiting
Name: Carolyn Liebsack
Phone: 623-832-6514
Email: Carolyn.liebsack@bannerhealth.com

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Recruiting
Name: Jose G. Macias
Phone:
Email: JMacias@mjhha.org

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Recruiting
Name: Teresa Villena, Dr.
Phone: 561-845-0500
Email: tvillena@aol.com

Geolocation is 42.3476181, -71.1002881

Site
Boston
Massachusetts
02215
Recruiting
Name: Avi Fuld
Phone: 617-667-0258
Email: afuld1@bidmc.harvard.edu

Geolocation is 36.1922841, -115.1592718

Site
Las Vegas
Nevada
89106
Recruiting
Name: Yolande Mucharbach
Phone: 702-685-7070
Email: muchary@ccf.org

Geolocation is 40.74727, -73.9800645

Site
New York
New York
10016
Recruiting
Name: Brittany Cerbone
Phone: 212-263-5845
Email: brittany.cerbone@nyumc.org

Geolocation is 41.4836446, -81.806039

Site
Cleveland
Ohio
44107
Recruiting
Name: Christine Whitman
Phone: 216-227-2438
Email: whitmac@ccf.rog
Lead Sponsor: 
Agency
Neuronix Ltd.
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Charlie Bernick, MD
Principal Investigator
Lou Ruvo Brain Center
Study Contact: 
NamePhoneEmail
Moran Ploznik
+972-4-9038603
Locations
 
 
ClinicalTrials.gov ID 
NCT01825330 (follow link to view full record on ct.gov in new window)
Official Title: 
Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients
Study Start Date: 
October 2013
Study End Date: 
December 2014
Disease Stage: 
Early
Middle
Enrollment: 
120