Effect of NeuroAD on the Cognitive Function of Alzheimer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01825330|
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : March 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Device: TMS and cognitive stimulation Device: sham||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
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.
- Efficacy [ Time Frame: 7 weeks ]Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
- Efficacy [ Time Frame: 7 weeks ]Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change
- Efficacy [ Time Frame: 12 weeks ]Change from baseline to week 12 in ADAS-Cog score.
- Safety [ Time Frame: 12 weeks ]Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|