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

Cognito Therapeutics

Status: Unknown

Conditions: Alzheimer Dementia; Cognitive Impairment; Memory Disorders; Alzheimer Disease, Late Onset; Cognitive Decline; Memory Loss; Dementia, Alzheimer Type; Memory Impairment; Alzheimer Disease, Early Onset; Alzheimer Disease; Dementia, Mild; Mild Cognitive Impairment; Memory Disorders, Age Related

Treatments: Device: GammaSense Stimulation System (non-invasive, non-significant risk)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03661034

CA-0004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Cohort 1, Arm A

Experimental group

Description:

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

Treatment:

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

Cohort 1, Arm B

Experimental group

Description:

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

Treatment:

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

Cohort 2, Arm C

Experimental group

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)

Treatment:

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

Cohort 2, Arm D

Experimental group

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)

Treatment:

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