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Alzheimer Disease 2 / Alzheimer Disease / Spectris™ AD - Sham · Interventional Study
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed registration for a large, well-designed pivotal trial of a sensory stimulation device (Spectris™ AD) in mild to moderate Alzheimer's disease. No efficacy or safety results have been posted to the registry, so the clinical impact cannot be assessed from this record alone.
Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Alzheimer Disease, Alzheimer Disease 1, Alzheimer Disease 2, Alzheimer Disease 3, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer Dise…; age from 50 Years; to 90 Years. Intervention: Active. Compared with: Sham — Sham Comparator. n = 673. 68 sites: United States.
This is a completed registration for a large, well-designed pivotal trial of a sensory stimulation device (Spectris™ AD) in mild to moderate Alzheimer's disease. No efficacy or safety results have been posted to the registry, so the clinical impact cannot be assessed from this record alone.
No efficacy, safety, or comparative data are available from this registry entry Efficacy outcomes, safety adverse events, and statistical analyses must be obtained from published results or ClinicalTrials.gov results section when posted
The source did not state who this applies to in practice.
This is a completed trial registry record with no reported results; the study enrolled 673 participants in a randomized sham-controlled design, but outcomes have not yet been posted to the registry.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05637801). This is a study registration, not published results. Lead sponsor: Cognito Therapeutics, Inc.. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 673 participants (ACTUAL). Conditions: 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. Interventions: DEVICE: Spectris™ AD - Active; DEVICE: Spectris™ AD - Sham. Primary outcome measures: Integrated Alzheimer's Disease MMSE ADCS-ADL Rating Scale (iADMARS) , Assessed for endpoint at Screening/Baseline and 12-Month clinic visits. Brief summary: 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.