An interventional study of GammaSense Stimulation System (Active Settings) and GammaSense Stimulation System (Sham Settings) in Alzheimer Disease, Cognitive Impairment and Mild Cognitive Impairment, sponsored by Cognito Therapeutics, Inc.. Active, not recruiting at 5 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Cognito Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Will use the Active GammaSense Stimulation System.
Device: GammaSense Stimulation System (Active Settings)
Will use the Sham GammaSense Stimulation System.
Device: GammaSense Stimulation System (Sham Settings)
Proprietary auditory and visual sensory stimulation device.
Proprietary auditory and visual sensory stimulation device.
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
Time frame: Quarterly over 6 months
Amyloid PET/CT
Time frame: Quarterly over 6 months
This study is active, not recruiting, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cognito Therapeutics, Inc.