Multi-Center Study of Sensory Stimulation to Improve Brain Function

Alzheimer Disease Clinical Trial

— Overture  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03556280
• Other study ID #: CA-0005
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: September 2021

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Cognitive Impairment, Mild
• Dementia
• Dementia Alzheimers
• Dementia of Alzheimer Type
• Dementia, Alzheimer Type
• Dementia, Mild
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	Brain Matters Research	Delray Beach	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	Brain Matters Research	Stuart	Florida

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	Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)	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	Quarterly over 6 months
Secondary	Amyloid PET/CT		Quarterly over 6 months