Alzheimer Disease Clinical Trial
Official title:
Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
Verified date | August 2021 |
Source | Cognito Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | March 1, 2022 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Boston Center for Memory | Newton | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Cognito Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month) | |
Primary | 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). | Over 12 months | |
Secondary | 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. | Baseline, 3, 6, 9 and 12 months |
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