Multi-Center Study of Sensory Stimulation to Improve Brain Function

Not Applicable

Active, not recruiting

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia Alzheimers; Dementia; Cognitive Impairment; Dementia, Mild; Cognitive Impairment, Mild; Cognitive Decline; Dementia, Alzheimer Type; Dementia of Alzheimer Type

• Registration Number: NCT03556280
• Lead Sponsor: Cognito Therapeutics, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-04-24
• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-14
• Primary Completion: 2020-08-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Amyloid PET/CT	Quarterly over 6 months

Trial Locations

Locations (4)

Brain Matters Research; 🇺🇸 Stuart, Florida, United States

ActivMed Practices & Research, Inc; 🇺🇸 Methuen, Massachusetts, United States

Boston Center for Memory; 🇺🇸 Newton, Massachusetts, United States

The Cognitive and Research Center of New Jersey; 🇺🇸 Springfield, New Jersey, United States