The study tests the effect of the NeuroAD on Alzheimer patients' cognitive function. The NeuroAD uses non-invasive stimulation of both magnetic and cognitive training.
The NeuroAD system is a combined system of Transcranial Magnetic Stimulation and cognitive training and is a non-invasive therapeutic system for the improvement of Alzheimer patients' cognitive function. A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment or sham (placebo) Patient will attend the clinic 5 times a week for 6 weeks, approximately an hour every day for treatment/sham. The patient will be required to return to the clinic for follow-up. Up to 150 patients will be enrolled in up to 10 clinical sites in the US and Israel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
131
Synchronized TMS and cognitive stimulation to 6 brain areas.
Banner Sun Health Research Institute
Sun City, Arizona, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Miami Jewish Health Systems
Miami, Florida, United States
Efficacy
Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Time frame: 7 weeks
Efficacy
Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change
Time frame: 7 weeks
Efficacy
Change from baseline to week 12 in ADAS-Cog score.
Time frame: 12 weeks
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Roskamp Institute Clinic
Sarasota, Florida, United States
Palm Beach Neurology and Premiere Research Institute
West Palm Beach, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cleveland Clinic Lou Ruvo Brain Center
Las Vegas, Nevada, United States
NYU Langone Medical Center
New York, New York, United States
Cleveland Clinic Center for Brain Health Lakewood Hospital
Cleveland, Ohio, United States
Assaf Harofe Medical Center
Beer Yaakov, Israel