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

Launched by COGNITO THERAPEUTICS, INC. · Feb 4, 2024

Keywords

ClinConnect 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.

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

Gender

ALL

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