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Active, Not Recruiting

NCT Number: NCT03556280

Multi-Center Study of Sensory Stimulation to Improve Brain Function

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Cognitive Impairment Cognitive Impairment, Mild Dementia Dementia Alzheimers Dementia of Alzheimer Type Dementia, Alzheimer Type Dementia, Mild Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Mild Cognitive Impairment Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Matters Research, Delray Beach, Florida, United States

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About this study

The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older.

Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GammaSense Stimulation System (Active Settings)

Device

Proprietary auditory and visual sensory stimulation device.

GammaSense Stimulation System (Sham Settings)

Device

Proprietary auditory and visual sensory stimulation device.

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Amyloid PET/CT

    Time frame: Quarterly over 6 months

Sponsors and collaborators

Lead sponsor

Cognito Therapeutics, Inc.

Industry

Registry information

Official study title

Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)

Acronym: Overture

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 14, 2018
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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