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The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.
Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Arm A | Experimental | Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk) |
|
| Cohort 1, Arm B | Experimental | Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk) |
|
| Cohort 2, Arm C | Experimental | Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk) |
|
| Cohort 2, Arm D | Experimental | Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaSense Stimulation System (non-invasive, non-significant risk) | Device | Non-invasive, non-significant risk audio-visual sensory stimulation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Amyloid Positron Emission Tomography (PET) Scan | Movement of amyloid, as measured qualitatively and quantitatively in Amyloid PET Imaging at 0, 1.5, 3, 6, 9 and 12 months following assigned regimen of sensory stimulation treatment sessions | PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month) |
| Adverse Events | Composite adverse events to be assessed at Interim Analysis (at any point in partial study completion), and final analysis (at 6 and 12 months time points). | Over 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | A scale used to assess cognition; This scale consists of 14 questions assessed resulting in a score from 0 to 90, where a higher score indicates more cognitive disruption. | Baseline, 3, 6, 9 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan R Hempel | Cognito Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Center for Memory | Newton | Massachusetts | 02459 | United States |
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Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)
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|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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