NCT03661034

Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)

Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cognito Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.

Detailed description

Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.

Conditions

• Alzheimer Disease, Early Onset
• Alzheimer Disease
• Alzheimer Dementia
• Mild Cognitive Impairment
• Memory Disorders
• Memory Loss
• Memory Impairment
• Memory Disorders, Age Related
• Alzheimer Disease, Late Onset
• Cognitive Impairment
• Dementia, Mild
• Dementia, Alzheimer Type
• Cognitive Decline

Interventions

Type	Name	Description
DEVICE	GammaSense Stimulation System (non-invasive, non-significant risk)	Non-invasive, non-significant risk audio-visual sensory stimulation device

Timeline

• Start date: 2018-05-31
• Primary completion: 2021-05-01
• Completion: 2022-03-01
• First posted: 2018-09-07
• Last updated: 2021-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study