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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroAD | Active Comparator | NeuroAD treatment, synchronized TMS and cognitive training stimulation |
|
| Sham TMS+Cog | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS and cognitive stimulation | Device | Synchronized TMS and cognitive stimulation to 6 brain areas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Change from Baseline to week 7 in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Change from baseline to week 7 in CGI-C score. CGI-C: Clinical Global Impression of Change | 7 weeks |
| Efficacy | Change from baseline to week 12 in ADAS-Cog score. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse events, including Serious Adverse Events occurring at any time during the trial and follow-up. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlie Bernick, MD | Lou Ruvo Brain Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States | ||
| ATP Clinical Research, Inc. |
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| Label | URL |
|---|---|
| Sponsor's website | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| sham | Device |
|
| 12 weeks |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| Roskamp Institute Clinic | Sarasota | Florida | 34243 | United States |
| Palm Beach Neurology and Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Cleveland Clinic Lou Ruvo Brain Center | Las Vegas | Nevada | 89106 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Cleveland Clinic Center for Brain Health Lakewood Hospital | Cleveland | Ohio | 44107 | United States |
| Assaf Harofe Medical Center | Beer Yaakov | Israel |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |