Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015) (NCT06245031) | Clinical Trial Compass
By InvitationNot Applicable
Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)
United States402 participantsStarted 2024-02-29
Plain-language summary
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.
Who can participate
Age range
50 Years – 92 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
Timeframe: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits