An interventional study of Spectris™ AD - Active and Spectris™ AD - Sham in Alzheimer Disease, Alzheimer Disease 1 and Alzheimer Disease 2, sponsored by Cognito Therapeutics, Inc.. Completed at 68 sites in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Cognito Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Serious neurological diseases affecting the Central Nervous System, including:
Participants involved in the Fluid Biomarker substudy also must not have contraindications to lumbar puncture.
For more information visit: https://www.hopestudyforad.com/
Active Group: Subjects are treated with the Active Spectris™ AD at home for 60 minutes daily for approximately 12 months.
Device: Spectris™ AD - Active
Sham Group: Subjects are treated with a Sham Spectris™ AD at home for 60 minutes daily for approximately 12 months
Device: Spectris™ AD - Sham
Spectris™ AD - Active settings
Spectris™ AD - Sham settings
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
Plan to share: No
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Cognito Therapeutics, Inc.