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

NCT03661034 | Unknown DMC FDA Device

• 1 other identifier: CA-0004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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).

  Over 12 months

Secondary Outcomes (1)

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

  Baseline, 3, 6, 9 and 12 months

Study Arms (4)

Cohort 1, Arm A

EXPERIMENTAL

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

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

Cohort 1, Arm B

EXPERIMENTAL

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)

Cohort 2, Arm C

EXPERIMENTAL

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)

Cohort 2, Arm D

EXPERIMENTAL

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)

Interventions

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

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

Also known as: FG-0003

Cohort 1, Arm A; Cohort 1, Arm B; Cohort 2, Arm C; Cohort 2, Arm D

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

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

Sponsors & Collaborators

• Cognito Therapeutics, Inc.: lead

Study Sites (1)

Boston Center for Memory

Newton, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Memory Disorders; Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Evan R Hempel

  Cognito Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: September 7, 2018
• Study Start: May 31, 2018
• Primary Completion: May 1, 2021
• Study Completion: March 1, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)