Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of NeuroAD, Combined TMS Stimulation and Cognitive Training, on the Cognitive Function of Mild to Moderate Alzheimer Patients|
- Efficacy [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
- Efficacy [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change
- Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change from baseline to week 12 in ADAS-Cog score.
- Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.
|Study Start Date:||October 2013|
|Study Completion Date:||March 2016|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: NeuroAD
NeuroAD treatment, synchronized TMS and cognitive training stimulation
Device: TMS and cognitive stimulation
Synchronized TMS and cognitive stimulation to 6 brain areas.
Sham Comparator: Sham TMS+Cog
Sham device, has the same appearance and sound as the real device, combined with sham cognitive exercises. Patients come for the same number of sessions, delivers no real stimulation or 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01825330
|United States, Arizona|
|Banner Sun Health Research Institute|
|Sun City, Arizona, United States, 85351|
|United States, California|
|ATP Clinical Research, Inc.|
|Costa Mesa, California, United States, 92626|
|United States, Florida|
|Miami Jewish Health Systems|
|Miami, Florida, United States, 33137|
|Roskamp Institute Clinic|
|Sarasota, Florida, United States, 34243|
|Palm Beach Neurology and Premiere Research Institute|
|West Palm Beach, Florida, United States, 33407|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Nevada|
|Cleveland Clinic Lou Ruvo Brain Center|
|Las Vegas, Nevada, United States, 89106|
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|United States, Ohio|
|Cleveland Clinic Center for Brain Health Lakewood Hospital|
|Cleveland, Ohio, United States, 44107|
|Assaf Harofe Medical Center|
|Beer Yaakov, Israel|
|Principal Investigator:||Charlie Bernick, MD||Lou Ruvo Brain Center|