Multi-Center Study of Sensory Stimulation to Improve Brain Function

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

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.

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.

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)