Clinical trial · Interventional
Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)
Open-Label Extension to a Randomized, Double-blind, Sham-controlled, Adaptive-Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (OLE Hope Study, CA-0015)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AD | — | UNRESOLVED | — |
| Alzheimer Disease | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Dementia Alzheimers | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
| Dementia Moderate | — | UNRESOLVED | — |
| Dementia of Alzheimer Type | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sensory Stimulation System (GS120) - Active | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Active
- description
- All subjects will receive a device with Active settings for use daily at home for 60-minutes for 12 months.
- interventionNames
- Device: Sensory Stimulation System (GS120) - Active
Primary outcomes (2)
- measure
- Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
- timeFrame
- Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
- description
- Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease)
- measure
- Change from Baseline in a Combined Statistical Test (CST) that creates a composite measure (combining Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) scales into one measure) at 12-Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 92 Years
Show eligibility criteria text
Inclusion Criteria: * Randomized and completed 12-months of participation in the Hope Study (CA-0011) * Non-childbearing potential or using adequate birth control * Available/consenting Study Partner Exclusion Criteria: * Insufficient adherence to treatment in the Hope Study (CA-0011) * Living in continuous care nursing home (assisted living permitted) * Initiating or ongoing treatment with any of the following during study participation: * Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies) * Memantine (Namenda or Namzaric) * Nootropic drugs except stable acetylcholinesterase inhibitors For more information about the Hope Study (CA-0011) that participants in this study complete first, please see: https://www.hopestudyforad.com/ or the Hope Study ClinicalTrials.gov posting here: https://clinicaltrials.gov/study/NCT05637801
References
Publications (0)
Data not yet available