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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03661034
• Other study ID #: CA-0004
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2021
• Source: Cognito Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Alzheimer Disease, Early Onset
• Alzheimer Disease, Late Onset
• Amnesia
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Dementia, Alzheimer Type
• Dementia, Mild
• Disease
• Memory Disorders
• Memory Disorders, Age Related
• Memory Impairment
• Memory Loss
• Mild Cognitive Impairment

Intervention

Device:
• GammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device

Locations

Country	Name	City	State
United States	Boston Center for Memory	Newton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cognito Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	Baseline, 3, 6, 9 and 12 months