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

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ClinicalTrials.gov Identifier: NCT03661034
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Cognito Therapeutics, Inc.

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 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
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


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




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.



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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)

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


Contacts
Contact: Evan R Hempel 857-201-5088 info@cognitotx.com

Locations
United States, Massachusetts
Boston Center for Memory Recruiting
Newton, Massachusetts, United States, 02459
Contact: Linh Huynh, PharmD    617-699-6927    linh@bostonmemory.com   
Sponsors and Collaborators
Cognito Therapeutics, Inc.
Investigators
Study Chair: Evan R Hempel Cognito Therapeutics

Responsible Party: Cognito Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03661034     History of Changes
Other Study ID Numbers: CA-0004
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No
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:
Disease
Alzheimer Disease
Dementia
Cognitive Dysfunction
Memory Disorders
Amnesia
Late Onset Disorders
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Disease Attributes