Multi-Center Study of Sensory Stimulation to Improve Brain Function

NCT03556280 · tracked via the Priya Life Science USA tracker

Sponsor

Cognito Therapeutics, Inc.

Phase

Not applicable

Started

2018-04-24

Last updated

2021-08-24

Condition(s) studied

Alzheimer DiseaseCognitive ImpairmentMild Cognitive ImpairmentDementia AlzheimersDementia, MildDementia, Alzheimer TypeDementia of Alzheimer TypeDementiaCognitive Impairment, MildCognitive Decline

Investigational drug(s) / intervention(s)

GammaSense Stimulation System (Active Settings)GammaSense Stimulation System (Sham Settings)

GammaSense Stimulation System (Active Settings): Proprietary auditory and visual sensory stimulation device.

GammaSense Stimulation System (Sham Settings): Proprietary auditory and visual sensory stimulation device.

Study summary

The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.

Eligibility

Sex

ALL

Min age

55 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * \>= 55 Years old * MMSE 14-26 * Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD * Participation of a caregiver Exclusion Criteria: * Profound hearing or visual impairment * Seizure Disorder * Use of memantine (Namenda or Namzaric) * Implantable devices (non-MR compatible)

Primary outcome measure(s)

Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) — Quarterly over 6 months
A widely accepted, validated measure of cognitive function in Alzheimer's Disease consisting of 14 questions that result in a score ranging from 0 to 90 with higher scores representing greater cognitive impairment

Trial sites (5)

Facility	City	Region
Brain Matters Research	Delray Beach	Florida
Brain Matters Research	Stuart	Florida
ActivMed Practices & Research, Inc	Methuen	Massachusetts
Boston Center for Memory	Newton	Massachusetts
The Cognitive and Research Center of New Jersey	Springfield	New Jersey

More Cognito Therapeutics, Inc. trials in the USA

Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015) Enrolling by invitation

Other trials for the same condition

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease Recruiting

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) Active, not recruiting

A Study of LY3439539 in Participants With Alzheimer's Disease Recruiting

Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease Recruiting

Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03556280 on ClinicalTrials.gov ↗ ← All trials in the USA