This is a randomized, double-blind, sham-controlled pivotal study of sensory stimulation in subjects with mild to moderate AD. Up to approximately 670 subjects will be treated with either Active or Sham investigational device, Spectris™ AD, for 60 minutes daily for approximately 12 months. Efficacy will be measured using the Integrated Alzheimer's Disease Mini-Mental State Exam (MMSE) Activities of Daily Living (ADCS-ADL) Rating Scale (iADMARS).
This is a multicenter, randomized, double-blind, sham-controlled pivotal study. The objective of this study is to assess the safety and efficacy of gamma sensory stimulation (visual and audio) via Spectris ™ AD in slowing cognitive-functional symptom worsening versus the Sham device for subjects with mild to moderate AD as measured by changes in function and cognition. Up to approximately six hundred and seventy (670) subjects with Mild to Moderate AD (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Active : Sham). In the Active Group, subjects will be treated with the Active Spectris™ AD for 60 minutes daily. In the Sham Group, subjects are treated with a Sham Spectris™ AD for 60 minutes daily. Daily treatment is planned for approximately 12 months. Subjects will attend study visits for informed consent, screening and baseline, then at 3-Months, 6-Months, 9-Months (by phone), 12 Months and 13 Months (for safety follow-up). Some clinical sites will be included in a substudy evaluating additional fluid biomarkers. Select subjects enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
670
Spectris™ AD - Active settings
Spectris™ AD - Sham settings
CCT Research - Gilbert Neurology Partners
Gilbert, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
CCT Research - Foothills Research Center
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Advanced Research Center, Inc
Anaheim, California, United States
Integrated Alzheimer's Disease MMSE ADCS-ADL Rating Scale (iADMARS)
Comparing the change from baseline (CFB) to 12 months in iADMARS between active vs sham groups.
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Alzheimer's Disease Cooperative Study-Activities of Daily Living ADCS-ADL
Function as measured by ADCS-ADL
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Mini-Mental State Examination (MMSE)
Cognition as measured by MMSE
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Alzheimer's Disease Cooperative Study- instrumental Activities of Daily Living (ADCS-iADL)
Function and cognition as measured by ADCS-iADL
Time frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Office of Elizabeth Zarate-Rowell, MD
Seal Beach, California, United States
Mile High Research Center
Denver, Colorado, United States
...and 58 more locations