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

Primary Purpose

Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GammaSense Stimulation System (Active Settings)
GammaSense Stimulation System (Sham Settings)
Sponsored by
Cognito Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Dementia, Alzheimer's Disease, Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brain Matters Research
  • Brain Matters Research
  • ActivMed Practices & Research, Inc
  • Boston Center for Memory
  • The Cognitive and Research Center of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Group

Control Group

Arm Description

Will use the Active GammaSense Stimulation System.

Will use the Sham GammaSense Stimulation System.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Amyloid PET/CT

Full Information

First Posted
May 22, 2018
Last Updated
August 23, 2021
Sponsor
Cognito Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03556280
Brief Title
Multi-Center Study of Sensory Stimulation to Improve Brain Function
Acronym
Overture
Official Title
Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cognito Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Impairment, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mild, Dementia, Alzheimer Type, Dementia of Alzheimer Type, Dementia, Cognitive Impairment, Mild, Cognitive Decline
Keywords
Dementia, Alzheimer's Disease, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Will use the Active GammaSense Stimulation System.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Will use the Sham GammaSense Stimulation System.
Intervention Type
Device
Intervention Name(s)
GammaSense Stimulation System (Active Settings)
Intervention Description
Proprietary auditory and visual sensory stimulation device.
Intervention Type
Device
Intervention Name(s)
GammaSense Stimulation System (Sham Settings)
Intervention Description
Proprietary auditory and visual sensory stimulation device.
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
Description
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
Time Frame
Quarterly over 6 months
Secondary Outcome Measure Information:
Title
Amyloid PET/CT
Time Frame
Quarterly over 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Brain Matters Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
ActivMed Practices & Research, Inc
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
The Cognitive and Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34630050
Citation
Cimenser A, Hempel E, Travers T, Strozewski N, Martin K, Malchano Z, Hajos M. Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients. Front Syst Neurosci. 2021 Sep 24;15:746859. doi: 10.3389/fnsys.2021.746859. eCollection 2021.
Results Reference
derived

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Multi-Center Study of Sensory Stimulation to Improve Brain Function

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