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

• Sponsor: Cognito Therapeutics, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03556280
• Collaborator: (none)
• Enrollment: 60
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 40.3
• Patients Per Site: 12
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Cognitive Impairment; Mild Cognitive Impairment; Dementia Alzheimers; Dementia, Mild; Dementia, Alzheimer Type; Dementia of Alzheimer Type; Dementia; Cognitive Impairment, Mild; Cognitive Decline	Device: GammaSense Stimulation System (Active Settings); Device: GammaSense Stimulation System (Sham Settings)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
• Actual Study Start Date: Apr 24, 2018
• Actual Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Will use the Active GammaSense Stimulation System.	Device: GammaSense Stimulation System (Active Settings); Proprietary auditory and visual sensory stimulation device.
Sham Comparator: Control Group Will use the Sham GammaSense Stimulation System.	Device: GammaSense Stimulation System (Sham Settings); Proprietary auditory and visual sensory stimulation device.

Outcome Measures

Primary Outcome Measures

1. 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

1. Amyloid PET/CT [Quarterly over 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brain Matters Research	Delray Beach	Florida	United States	33445
2	Brain Matters Research	Stuart	Florida	United States	34994
3	ActivMed Practices & Research, Inc	Methuen	Massachusetts	United States	01844
4	Boston Center for Memory	Newton	Massachusetts	United States	02459
5	The Cognitive and Research Center of New Jersey	Springfield	New Jersey	United States	07081

Sponsors and Collaborators

• Cognito Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cognito Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03556280
• Other Study ID Numbers: CA-0005
• First Posted: Jun 14, 2018
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Cognito Therapeutics, Inc.: Dementia; Alzheimer's Disease; Cognitive Impairment
• Additional relevant MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction

Study Results

No Results Posted as of Aug 24, 2021