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

Cognito Therapeutics

Status: Active, not recruiting

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

Treatments: Device: GammaSense Stimulation System (Sham Settings); Device: GammaSense Stimulation System (Active Settings)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03556280

CA-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Will use the Active GammaSense Stimulation System.

Treatment:

Device: GammaSense Stimulation System (Active Settings)

Control Group

Sham Comparator group

Description:

Will use the Sham GammaSense Stimulation System.

Treatment:

Device: GammaSense Stimulation System (Sham Settings)