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Trial record 2 of 2 for:    visual auditory stimulation | Alzheimer Disease

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556280
Recruitment Status : Active, not recruiting
First Posted : June 14, 2018
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Cognito Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03556280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
Amyloid PET/CT [ Time Frame: Quarterly over 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-Center Study of Sensory Stimulation to Improve Brain Function
Official Title  ICMJE Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Cognitive Impairment
  • Mild Cognitive Impairment
  • Dementia Alzheimers
  • Dementia, Mild
  • Dementia, Alzheimer Type
  • Dementia of Alzheimer Type
  • Dementia
  • Cognitive Impairment, Mild
  • Cognitive Decline
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Treatment Group
    Will use the Active GammaSense Stimulation System.
    Intervention: Device: GammaSense Stimulation System (Active Settings)
  • Sham Comparator: Control Group
    Will use the Sham GammaSense Stimulation System.
    Intervention: Device: GammaSense Stimulation System (Sham Settings)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03556280
Other Study ID Numbers  ICMJE CA-0005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cognito Therapeutics, Inc.
Study Sponsor  ICMJE Cognito Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cognito Therapeutics, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP