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Administrative decision
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To evaluate the long-term efficacy of the NeuroAD system
To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function
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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 |
|---|---|---|---|---|
| NeuroAD | Device | Synchronized TMS and cognitive stimulation to 6 brain areas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Change from Baseline to 3 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Change from Baseline to week 7 in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change | 7 weeks |
| Efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up | 9 Months |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek | Jerusalem | 9103102 | Israel |
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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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| Sham TMS+Cog | Device | Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises. |
|
Change from Baseline to 6 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
| 6 Months |
| Efficacy | Change from Baseline to 9 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change | 9 Months |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |