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

Primary Purpose

Alzheimer Disease, Early Onset, Alzheimer Disease, Alzheimer Dementia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GammaSense Stimulation System (non-invasive, non-significant risk)

About this trial

This is an interventional treatment trial for Alzheimer Disease, Early Onset focused on measuring Dementia, Alzheimer's Disease, Memory Loss

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

Profound hearing or visual impairment
Seizure Disorder
Use of memantine (Namenda or Namzaric)
Implantable devices (non-MR compatible)

Sites / Locations

Boston Center for Memory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1, Arm A

Cohort 1, Arm B

Cohort 2, Arm C

Cohort 2, Arm D

Arm Description

Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)

Dosing 1 hour session twice per day with 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)

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)

Outcomes

Primary Outcome Measures

Change in Amyloid Positron Emission Tomography (PET) Scan

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

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)

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.

Full Information

NCT ID

NCT03661034

First Posted

August 1, 2018

Last Updated

August 23, 2021

Sponsor

Cognito Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03661034

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 31, 2018 (Actual)

Primary Completion Date

May 1, 2021 (Actual)

Study Completion Date

March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cognito Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Dementia, Alzheimer's Disease, Memory Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1, Arm A

Arm Type

Experimental

Arm Description

Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)

Arm Title

Cohort 1, Arm B

Arm Type

Experimental

Arm Description

Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)

Arm Title

Cohort 2, Arm C

Arm Type

Experimental

Arm Description

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)

Arm Title

Cohort 2, Arm D

Arm Type

Experimental

Arm Description

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 Type

Device

Intervention Name(s)

GammaSense Stimulation System (non-invasive, non-significant risk)

Other Intervention Name(s)

FG-0003

Intervention Description

Non-invasive, non-significant risk audio-visual sensory stimulation device

Primary Outcome Measure Information:

Title

Change in Amyloid Positron Emission Tomography (PET) Scan

Description

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

Time Frame

PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)

Title

Adverse Events

Description

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).

Time Frame

Over 12 months

Secondary Outcome Measure Information:

Title

Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Description

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.

Time Frame

Baseline, 3, 6, 9 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evan R Hempel

Organizational Affiliation

Cognito Therapeutics

Official's Role

Study Chair

Facility Information:

Facility Name

Boston Center for Memory

City

Newton

State/Province

Massachusetts

ZIP/Postal Code

02459

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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