New data from Cognito Therapeutics has indicated that its Spectris device increases cerebrospinal fluid (CSF) HDL-like lipid transport particles, suggesting the neuromodulation therapy prompts a “coordinated biological response” in patients with mild cognitive impairment (MCI).
Spectris is an investigational device that delivers synchronised auditory and visual stimuli to evoke gamma brain waves, with the aim to slow brain atrophy, preserve cognition, and improve daily functioning in patients with Alzheimer's disease. The headphone-like device secured breakthrough device designation from the US Food and Drug Administration (FDA) in 2021. While the fundamental biological workings of the device was already known, the new data unveils the specific pathways triggered by the therapy.
During a poster presentation at the 2026 Alzheimer's Association International Conference (AAIC), taking place in London, UK between 12-15 July, Cognito shared data from its Phase II FLICKER study that is evaluating daily Spectris sensory stimulation in patients with amyloid-positive MCI.
Using a mass spectrometry-based proteomics analysis, investigators found that daily Spectris treatment increased CSF levels of multiple HDL-like lipid transport proteins, including APOA1, APOA2 and APOL1. Pathway analysis further demonstrated that 13 of the 29 significantly upregulated biological pathways were associated with lipid transport or metabolism.
Calling the findings “particularly notable” given the lipid transport proteins were identified through an unbiased proteomics screen, Cognito said they suggest that a “coordinated biological response”, rather than isolated protein changes, is taking place in this patient population following Spectris treatment.
APOA1 is known to be associated with Alzheimer's disease biology, with published studies demonstrating an inverse relationship between CSF APOA1 levels and phosphorylated tau (pTau181), further supporting the biological relevance of this pathway, the company stated.
Cognito also highlighted that its analysis identified clear involvement of oligodendrocyte/myelination (M36) co-expression module, a pathway associated with myelin integrity and white matter biology. These findings resonate with previously reported MRI observations from Cognito's OVERTURE feasibility study that suggests Spectris treatment may result in the preservation of white matter and myelin.
Cognito’s CEO, Christian Howell, commented: “Every new dataset helps us build a more complete understanding of how non-invasive neuromodulation may impact the biology of Alzheimer's disease.
“The unbiased identification of coordinated lipid transport and myelination pathways is an encouraging finding that reinforces our scientific hypothesis and expands our understanding of Spectris' potential mechanism of action.
“Although these analyses are exploratory, they provide an important rationale for evaluating these biomarkers in future clinical studies as we continue advancing a new category of neuroprotective therapies.”
Cognito anticipates that it will be set to launch its Alzheimer’s disease therapeutic in the US by 2027. To support this effort, the company completed a $105m Series C financing round in March 2026.
