This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Approximately 345 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).
2 Primary · 4 Secondary · Reporting Duration: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Experimental Treatment
Non-Treatment Group
345 Total Participants · 2 Treatment Groups
Primary Treatment: Active · Has Placebo Group · N/A
Age 50 - 85 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:| Pennsylvania | 100.0% |
| Met criteria | 100.0% |
| 1 | 100.0% |
| Phone Call | 100.0% |