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Enrolling by invitation NCT06245031

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

No phase Interventional Alzheimer Disease Cognitive Impairment Mild Cognitive Impairment Dementia, Mild

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sensory Stimulation System (GS120) - Active.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment, Dementia, Mild. Basic parameters: 50 years — 92 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Detailed description

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.

Up to approximately 402 participants will complete the Hope Study and be offered participation in the OLE Hope Study at up to approximately 70 clinical sites.

The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression in the Active-Active group versus Active-Sham group for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE).

Participants will be treated with the Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months with Active device settings. Each participant will be involved in the study for up to 13 months: approximately 12 months of treatment and 1 month of safety follow-up.The visits in the study include: a Screening/Enrollment visit (Day 0), followed by telephone training on device receipt, a clinic visit at 12 months and a telephone visit at 6 and 13 months.

Interventions

  • Device Sensory Stimulation System (GS120) - Active
    Sensory Stimulation System (GS120) - Active settings

Primary outcome measures

  • Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months [Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits]
  • 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 [Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits]
Secondary outcome measures (1)
  • Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months [Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 53 centers
  • Barrow Neurological Institute — Phoenix
  • CCT Research - Foothills Research Center — Phoenix
  • Banner Sun Health Research Institute — Sun City
  • Advanced Research Center, Inc — Anaheim
  • ATP Clinical Research, Inc. — Costa Mesa
  • Neurology Center of North Orange County — Fullerton
  • Syrentis Clinical Research — Santa Ana
  • Office of Elizabeth Zarate-Rowell, MD — Seal Beach
  • … and 45 more centers

Identifiers

NCT: NCT06245031 · CA-0015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗