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

Sponsor

Cognito Therapeutics, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03661034

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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

Study Type:

Interventional

Anticipated 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)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

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: FG-0003

Outcome Measures

Primary Outcome Measures

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
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).

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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