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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 : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Cognito Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Cognitive Impairment Mild Cognitive Impairment Dementia Alzheimers Dementia, Mild Dementia, Alzheimer Type Dementia of Alzheimer Type Dementia Cognitive Impairment, Mild Cognitive Decline Device: GammaSense Stimulation System (Active Settings) Device: GammaSense Stimulation System (Sham Settings) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
Actual Study Start Date : April 24, 2018
Actual Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Amyloid PET/CT [ Time Frame: Quarterly over 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556280


Locations
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United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Brain Matters Research
Stuart, Florida, United States, 34994
United States, Massachusetts
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States, 01844
Boston Center for Memory
Newton, Massachusetts, United States, 02459
United States, New Jersey
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States, 07081
Sponsors and Collaborators
Cognito Therapeutics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cognito Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03556280    
Other Study ID Numbers: CA-0005
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021

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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
Keywords provided by Cognito Therapeutics, Inc.:
Dementia
Alzheimer's Disease
Cognitive Impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders