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Enrolling by Invitation

NCT Number: NCT06245031

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

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.

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Key information

Conditions

Alzheimer Disease AD Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Dementia Alzheimers Dementia Moderate Dementia of Alzheimer Type Dementia, Mild Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Mild Cognitive Impairment Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–92 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barrow Neurological Institute, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensory Stimulation System (GS120) - Active

Device

Sensory Stimulation System (GS120) - Active settings

Primary outcomes

  1. 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

    Function as measured by the ADCS-ADL (total score possible from 0-78, where a lower score is more affected by Alzheimer's disease)

  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

    Time frame: 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)

Secondary outcomes

  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

    Cognition as measured by MMSE (total score possible from 0-30, where a lower score is more affected by Alzheimer's disease)

Sponsors and collaborators

Lead sponsor

Cognito Therapeutics, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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