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

NCT06245031 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2024-05-07

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Sensory Stimulation System (GS120) - Active

Sensory Stimulation System (GS120) - Active settings

Sponsors & Collaborators

  • Cognito Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ralph Kern · Cognito Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
92 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06245031 on ClinicalTrials.gov