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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.

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date December 17, 2018
Actual Study Start Date  ICMJE May 31, 2018
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
  • 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
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
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.
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 Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
Official Title  ICMJE Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • 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
Intervention  ICMJE Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device
Other Name: FG-0003
Study Arms  ICMJE
  • Experimental: Cohort 1, Arm A
    Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)
    Intervention: Device: GammaSense Stimulation System (non-invasive, non-significant risk)
  • Experimental: Cohort 1, Arm B
    Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)
    Intervention: Device: GammaSense Stimulation System (non-invasive, non-significant risk)
  • 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)
    Intervention: Device: GammaSense Stimulation System (non-invasive, non-significant risk)
  • 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)
    Intervention: Device: GammaSense Stimulation System (non-invasive, non-significant risk)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Evan R Hempel 857-201-5088 info@cognitotx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661034
Other Study ID Numbers  ICMJE CA-0004
Has Data Monitoring Committee Yes
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cognito Therapeutics, Inc.
Study Sponsor  ICMJE Cognito Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Evan R Hempel Cognito Therapeutics
PRS Account Cognito Therapeutics, Inc.
Verification Date December 2018

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