Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)

Condition(s) studied

Investigational drug(s) / intervention(s)

Sensory Stimulation System (GS120) - Active: Sensory Stimulation System (GS120) - Active settings

Study 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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months — Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
  Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease)
• 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 — Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
  Function and Cognition as measured by CST of ADCS-ADL and MMSE (ADCS-ADL total score possible from 0-78, where a lower score is more affected by Alzheimer's disease) (MMSE total score possible from 0-30, where a lower score is more affected by Alzheimer's disease)

Trial sites (53)

+ 13 more sites — see the full list on the official registry below.

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