NCT03556280

Multi-Center Study of Sensory Stimulation to Improve Brain Function

Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cognito Therapeutics, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.

Detailed description

The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older. Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.

Conditions

• Alzheimer Disease
• Cognitive Impairment
• Mild Cognitive Impairment
• Dementia Alzheimers
• Dementia, Mild
• Dementia, Alzheimer Type
• Dementia of Alzheimer Type
• Dementia
• Cognitive Impairment, Mild
• Cognitive Decline

Interventions

Type	Name	Description
DEVICE	GammaSense Stimulation System (Active Settings)	Proprietary auditory and visual sensory stimulation device.
DEVICE	GammaSense Stimulation System (Sham Settings)	Proprietary auditory and visual sensory stimulation device.

Timeline

• Start date: 2018-04-24
• Primary completion: 2020-08-01
• Completion: 2021-09-01
• First posted: 2018-06-14
• Last updated: 2021-08-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study