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Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)

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: NCT03661034
Recruitment Status : Active, not recruiting
First Posted : September 7, 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 Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.

Condition or disease Intervention/treatment Phase
Alzheimer Disease, Early Onset Alzheimer Disease Alzheimer Dementia Mild Cognitive Impairment Memory Disorders Memory Loss Memory Impairment Memory Disorders, Age Related Alzheimer Disease, Late Onset Cognitive Impairment Dementia, Mild Dementia, Alzheimer Type Cognitive Decline Device: GammaSense Stimulation System (non-invasive, non-significant risk) Not Applicable

Detailed Description:
Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : May 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1, Arm A
Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)
 Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device
Other Name: FG-0003
Experimental: Cohort 1, Arm B
Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)
 Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device
Other Name: FG-0003
Experimental: Cohort 2, Arm C
Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)
 Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device
Other Name: FG-0003
Experimental: Cohort 2, Arm D
Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)
 Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device
Other Name: FG-0003


Outcome Measures
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Primary Outcome Measures :
  1. Change in Amyloid Positron Emission Tomography (PET) Scan [ Time Frame: PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month) ]
    Movement of amyloid, as measured qualitatively and quantitatively in Amyloid PET Imaging at 0, 1.5, 3, 6, 9 and 12 months following assigned regimen of sensory stimulation treatment sessions

  2. Adverse Events [ Time Frame: Over 12 months ]
    Composite adverse events to be assessed at Interim Analysis (at any point in partial study completion), and final analysis (at 6 and 12 months time points).


Secondary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) [ Time Frame: Baseline, 3, 6, 9 and 12 months ]
    A scale used to assess cognition; This scale consists of 14 questions assessed resulting in a score from 0 to 90, where a higher score indicates more cognitive disruption.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >= 50 Years Old
  • MMSE 24 - 30
  • Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
  • Participation of a caregiver / care partner
  • Amyloid Positive PET Scan

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): NCT03661034


Locations
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United States, Massachusetts
Boston Center for Memory
Newton, Massachusetts, United States, 02459
Sponsors and Collaborators
Cognito Therapeutics, Inc.
Investigators
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Study Chair: Evan R Hempel Cognito Therapeutics
More Information
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Responsible Party: Cognito Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03661034    
Other Study ID Numbers: CA-0004
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cognito Therapeutics, Inc.:
Dementia
Alzheimer's Disease
Memory Loss
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Memory Disorders
Amnesia
Disease
Late Onset Disorders
Cognitive Dysfunction
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Disease Attributes