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

August 23, 2021 updated by: Cognito Therapeutics, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Stuart, Florida, United States, 34994
        • Brain Matters Research
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research, Inc
      • Newton, Massachusetts, United States, 02459
        • Boston Center for Memory
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • The Cognitive and Research Center of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Will use the Active GammaSense Stimulation System.
Device: GammaSense Stimulation System (Active Settings)
Proprietary auditory and visual sensory stimulation device.
Sham Comparator: Control Group
Will use the Sham GammaSense Stimulation System.
Device: GammaSense Stimulation System (Sham Settings)
Proprietary auditory and visual sensory stimulation device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
Time Frame: Quarterly over 6 months
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 Outcome Measures

Outcome Measure
Time Frame
Amyloid PET/CT
Time Frame: Quarterly over 6 months
Quarterly over 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cognito Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

August 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-0005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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