An interventional study of GammaSense Stimulation System (non-invasive, non-significant risk) in Alzheimer Disease, Early Onset, Alzheimer Disease and Alzheimer Dementia, sponsored by Cognito Therapeutics, Inc.. Status unknown at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Cognito Therapeutics, Inc. · Not applicable, Interventional, and Treatment
The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.
Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.
Exclusion Criteria:
Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)
Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)
Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)
Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)
Device: GammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device
Also known as: FG-0003
Change in Amyloid Positron Emission Tomography (PET) Scan
Movement of amyloid, as measured qualitatively and quantitatively in Amyloid PET Imaging at 0, 1.5, 3, 6, 9 and 12 months following assigned regimen of sensory stimulation treatment sessions
Time frame: PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)
Adverse Events
Composite adverse events to be assessed at Interim Analysis (at any point in partial study completion), and final analysis (at 6 and 12 months time points).
Time frame: Over 12 months
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
A scale used to assess cognition; This scale consists of 14 questions assessed resulting in a score from 0 to 90, where a higher score indicates more cognitive disruption.
Time frame: Baseline, 3, 6, 9 and 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Cognito Therapeutics, Inc.