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

Not Applicable

• Conditions: Alzheimer Disease, Early Onset; Alzheimer Disease; Memory Impairment; Alzheimer Disease, Late Onset; Cognitive Impairment; Dementia, Mild; Mild Cognitive Impairment; Dementia, Alzheimer Type; Alzheimer Dementia; Memory Disorders
• Interventions: Device: GammaSense Stimulation System (non-invasive, non-significant risk)

• Registration Number: NCT03661034
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-05-31
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-07
• Primary Completion: 2021-05-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1, Arm B	GammaSense Stimulation System (non-invasive, non-significant risk)	Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)
Cohort 2, Arm C	GammaSense Stimulation System (non-invasive, non-significant risk)	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)
Cohort 1, Arm A	GammaSense Stimulation System (non-invasive, non-significant risk)	Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)
Cohort 2, Arm D	GammaSense Stimulation System (non-invasive, non-significant risk)	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)

Primary Outcome Measures

Name	Time	Method
Adverse Events	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).
Change in Amyloid Positron Emission Tomography (PET) Scan	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

Secondary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)	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.

Trial Locations

Locations (1)

Boston Center for Memory; 🇺🇸 Newton, Massachusetts, United States