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The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.
The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older.
Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Will use the Active GammaSense Stimulation System. |
|
| Control Group | Sham Comparator | Will use the Sham GammaSense Stimulation System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaSense Stimulation System (Active Settings) | Device | Proprietary auditory and visual sensory stimulation device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | A widely accepted, validated measure of cognitive function in Alzheimer's Disease consisting of 14 questions that result in a score ranging from 0 to 90 with higher scores representing greater cognitive impairment | Quarterly over 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Amyloid PET/CT | Quarterly over 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Matters Research | Delray Beach | Florida | 33445 | United States | ||
| Brain Matters Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40082316 | Derived | Carbonell F, Zijdenbos AP, Hempel E, Hajos M, Bedell BJ. A novel method for harmonization of PET image spatial resolution without phantoms. EJNMMI Phys. 2025 Mar 14;12(1):23. doi: 10.1186/s40658-025-00740-9. | |
| 38515445 | Derived | Hajos M, Boasso A, Hempel E, Shpokayte M, Konisky A, Seshagiri CV, Fomenko V, Kwan K, Nicodemus-Johnson J, Hendrix S, Vaughan B, Kern R, Megerian JT, Malchano Z. Safety, tolerability, and efficacy estimate of evoked gamma oscillation in mild to moderate Alzheimer's disease. Front Neurol. 2024 Mar 6;15:1343588. doi: 10.3389/fneur.2024.1343588. eCollection 2024. |
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| GammaSense Stimulation System (Sham Settings) | Device | Proprietary auditory and visual sensory stimulation device. |
|
| Stuart |
| Florida |
| 34994 |
| United States |
| ActivMed Practices & Research, Inc | Methuen | Massachusetts | 01844 | United States |
| Boston Center for Memory | Newton | Massachusetts | 02459 | United States |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| 34630050 | Derived | Cimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2024 | May 22, 2024 | 7 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| 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 |
| 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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