Alzheimer Disease, Cognitive Decline, Cognitive Impairment, Cognitive Impairment, Mild, Dementia, Dementia Alzheimers, Dementia, Alzheimer Type, Dementia, Mild, Dementia of Alzheimer Type, Mild Cognitive Impairment
Conditions
Keywords
Dementia, Alzheimer's Disease, Cognitive Impairment
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.
Interventions
DEVICEGammaSense Stimulation System (Active Settings)
Proprietary auditory and visual sensory stimulation device.
DEVICEGammaSense Stimulation System (Sham Settings)
Proprietary auditory and visual sensory stimulation device.
Sponsors
Cognito Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Amyloid PET/CT | Quarterly over 6 months |
Countries
United States
Outcome results
None listed