Alzheimer Dementia, Alzheimer Disease, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Cognitive Decline, Cognitive Impairment, Dementia, Alzheimer Type, Dementia, Mild, Memory Disorders, Memory Disorders, Age Related, Memory Impairment, Memory Loss, Mild Cognitive Impairment
Conditions
Keywords
Dementia, Alzheimer's Disease, Memory Loss
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGammaSense Stimulation System (non-invasive, non-significant risk)
Non-invasive, non-significant risk audio-visual sensory stimulation device
Sponsors
Cognito Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 50 Years Old * MMSE 24 - 30 * Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD * Participation of a caregiver / care partner * Amyloid Positive PET Scan
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 |
|---|---|---|
| Change in Amyloid Positron Emission Tomography (PET) Scan | PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month) | 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 |
| Adverse Events | Over 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | Baseline, 3, 6, 9 and 12 months | 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. |
Countries
United States
Outcome results
None listed