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NCT03556280 Clinical Trial

Multi-Center Study of Sensory Stimulation to Improve Brain Function

Alzheimer Disease Clinical Trial

— Overture  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03556280
Other study ID # CA-0005
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 24, 2018
Est. completion date September 2021

Study information
Verified date August 2021
Source Cognito Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date September 2021
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria: - >= 55 Years old - MMSE 14-26 - Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD - Participation of a caregiver Exclusion Criteria: - Profound hearing or visual impairment - Seizure Disorder - Use of memantine (Namenda or Namzaric) - Implantable devices (non-MR compatible)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• GammaSense Stimulation System (Active Settings)
Proprietary auditory and visual sensory stimulation device.
• GammaSense Stimulation System (Sham Settings)
Proprietary auditory and visual sensory stimulation device.

Locations
Country Name City State
United States Brain Matters Research Delray Beach Florida
United States ActivMed Practices & Research, Inc Methuen Massachusetts
United States Boston Center for Memory Newton Massachusetts
United States The Cognitive and Research Center of New Jersey Springfield New Jersey
United States Brain Matters Research Stuart Florida

Sponsors (1)
Lead Sponsor Collaborator
Cognito Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) A widely accepted, validated measure of cognitive function in Alzheimer's Disease consisting of 14 questions that result in a score ranging from 0 to 90 with higher scores representing greater cognitive impairment Quarterly over 6 months
Secondary Amyloid PET/CT Quarterly over 6 months
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