A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (HOPE Study) (NCT05637801)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (24 items).
Location: CCT Research - Gilbert Neurology Partners — Gilbert, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Seizure disorder
- Hospitalization in previous 30 days
- Living in continuous care nursing home (assisted living permitted)
- Inability to have an MRI or significant abnormality on MRI screening
- Geriatric Depression Scale (GDS) \>6
- Suicidality (current or previous 6 months)
- Serious neurological diseases affecting the Central Nervous System, including:
- other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),
- neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc),
- serious infection of the brain (meningitis/encephalitis), or
- history of multiple concussions.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (68 Sites)
- CCT Research - Gilbert Neurology Partners — Gilbert, Arizona
- Barrow Neurological Institute — Phoenix, Arizona
- CCT Research - Foothills Research Center — Phoenix, Arizona
- Banner Sun Health Research Institute — Sun City, Arizona
- Advanced Research Center, Inc — Anaheim, California
- ATP Clinical Research, Inc. — Costa Mesa, California
- Neurology Center of North Orange County — Fullerton, California
- Syrentis Clinical Research — Santa Ana, California
- Office of Elizabeth Zarate-Rowell, MD — Seal Beach, California
- Mile High Research Center — Denver, Colorado
- JEM Research Institute — Atlantis, Florida
- Visionary Investigators Network- Aventura — Aventura, Florida
- South Lake Pain Institute — Clermont, Florida
- Arrow Clinical Trials — Daytona Beach, Florida
- Brain Matters Research — Delray Beach, Florida
- Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida
- Alphab Global Research — Jupiter, Florida
- Charter Research - Lady Lake — Lady Lake, Florida
- Multi-Specialty Research Associates, Inc. — Lake City, Florida
- Premier Clinical Research Institute Inc. — Miami, Florida
- Visionary Investigators Network- Miami — Miami, Florida
- Aqualane Clinical Research — Naples, Florida
- Coastal Family Medicine - Orange Park — Orange Park, Florida
- K2 Medical Research - Orlando — Orlando, Florida
- Emerald Coast Neurology — Pensacola, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.