A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (HOPE Study)
Running, not enrolling · Not applicable · Has a placebo group
Conditions studied: Alzheimer Disease, Alzheimer Disease 1, Alzheimer Disease 2, Alzheimer Disease 3, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer Disease 9, Alzheimer Disease 4, Alzheimer Disease 7, Alzheimer Disease 17, Alzheimer's Dementia Late Onset, Alzheimer Disease 5, Alzheimer Disease 6, Alzheimer Disease 8, Alzheimer Disease 10, Alzheimer Disease 11, Alzheimer Disease 12, Alzheimer Disease 13, Alzheimer Disease 14, Alzheimer Disease 15, Alzheimer Disease 16, Alzheimer Disease 18, Alzheimer Disease 19, Dementia, Dementia Alzheimers, Dementia, Mild, Dementia of Alzheimer Type, Dementia Moderate, Dementia Senile, Mild Cognitive Impairment, Mild Dementia, MCI, Cognitive Impairment, Cognitive Decline, Cognitive Impairment, Mild
In brief
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).
Key facts
- Study ID
- NCT05637801
- Run by
- Cognito Therapeutics, Inc.
- People needed
- 670
- Starts
- 2022-12-13
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and Women age 50-90
- Alzheimer's disease diagnosis with at least 6-month decline in cognitive function
- Non-childbearing potential or using adequate birth control
- Mini-Mental State Exam (MMSE) 15-28
- Available/consenting Study Partner
- Able to identify a Legally Authorized Representative (LAR)
- Stable chronic conditions at least 30 days
- Formal education of 8 or more years
- Adequate vision (Able to detect light) and hearing
- Mobility sufficient for compliance with testing procedures (ambulatory or aided-ambulatory, i.e. cane or walker)
- Amyloid or phosphorylated Tau positivity
You may not qualify if…
- 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.
- Metabolic or systemic diseases affecting the central nervous system (syphilis, B12 or folate deficiency, etc)
- Schizophrenia or bipolar disorder
- Heart disease, chronic liver, kidney, or respiratory disease, or uncontrolled diabetes or thyroid disease
- Cancer history within previous 2 years (except resolved non-melanoma skin or stable prostate)
- Nootropic drugs except stable acetylcholinesterase inhibitors
- Drug or Alcohol abuse in previous 12 months
- Previous exposure to Anti-amyloid-beta vaccines
- Past Exposure to Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
- Exposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitors within the 6 months prior to consent
- Involved in a previous Cognito study or gamma therapy study
- Active treatment with Memantine (Namenda or Namzaric) within previous 30 days
- Life expectancy < 24 months
- Participants involved in the Fluid Biomarker substudy also must not have contraindications to lumbar puncture.
- For more information visit: https://www.hopestudyforad.com/
Where it is running
- 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
- 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
- JEM Research Institute — Atlantis, Florida, United States
- Visionary Investigators Network- Aventura — Aventura, Florida, United States
- TRS Health — Stafford, Texas, United States
- South Lake Pain Institute — Clermont, Florida, United States
- Arrow Clinical Trials — Daytona Beach, Florida, United States
- Brain Matters Research — Delray Beach, Florida, United States
- Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
- Alphab Global Research — Jupiter, Florida, United States
- Charter Research - Lady Lake — Lady Lake, Florida, United States
- Multi-Specialty Research Associates, Inc. — Lake City, Florida, United States
- Premier Clinical Research Institute Inc. — Miami, Florida, United States
- Visionary Investigators Network- Miami — Miami, Florida, United States
- Aqualane Clinical Research — Naples, Florida, United States
- Coastal Family Medicine - Orange Park — Orange Park, Florida, United States
- Mercury Clinical Research — Sugarland, Texas, United States
Full record on ClinicalTrials.gov
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