Cognito Therapeutics has presented new data demonstrating its Spectris neuromodulation device’s potential to slow cognitive decline and preserve white matter in patients with mild to moderate Alzheimer’s disease.
Spectris is an at-home neuromodulation therapy designed to treat Alzheimer’s disease by using synchronised light and sound sensory stimulation via a headset to invoke brain gamma oscillations.
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Data from Cognito’s OVERTURE trial (NCT03556280) and OVERTURE open-label extension (OLE) study demonstrated that patients treated with its non-invasive therapy experienced significant “time saved” in functional and structural decline at both six and 18 months.
The findings were presented at the Alzheimer’s Association International Conference (AAIC), taking place in Toronto, Canada, between 27-31 July.
Data from OVERTURE OLE revealed that Spectris treatment resulted in 8.66 months in ‘time saved’ in activities of daily living as measured by the functional assessment scale Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL), 9.93 months in cognitive function per the Mini Mental State Examination (MMSE), and 7.48 months in whole-brain volume.
MRI-based analyses also revealed that Spectris preserved white matter and myelin integrity across multiple brain regions. According to Cognito, the finding suggests there is a structural neuroprotective effect associated with Spectris’ 40Hz gamma frequency stimulation mechanism.
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By GlobalDataCognito Therapeutics CEO Christian Howell commented: “The new findings presented at AAIC reinforce the potential of Spectris to not only slow cognitive and functional decline, but to provide meaningful structural preservation that could shift the treatment paradigm in Alzheimer’s disease.
Spectris is also being evaluated in the HOPE pivotal trial (NCT05637801), which completed enrolment earlier this month.
Market entrants developing neuromodulation therapies for Alzheimer’s disease
According to GlobalData analysis, the global neuromodulation device market is projected to reach a valuation of $12.3bn by 2034, up from $6.3bn in 2024.
Several companies are skirting pharmaceuticals and working on the development of neuromodulation therapies for treating Alzheimer’s disease. Aside from Cognito, other companies in the space include Neuropod and Sinaptica Therapeutics.
Neuropod is combining radiofrequency stimulation, photobiomodulation, and gamma frequency entrainment in one device to target deep brain regions involved in memory, attention, and executive function and reduce the Alzheimer’s disease hallmarks of β-amyloid plaque buildup and tau tangles.
Sinaptica’s SinaptiStim system is designed to deliver tailored rapid transcranial magnetic stimulation (rTMS) therapy targeting the Default Mode Network (DMN). The company is currently enrolling patients in a Phase II trial of the device, which received a breakthrough device designation from the US Food and Drug Administration (FDA) in 2022.
Buzz in the Alzheimer’s disease space in recent years has otherwise been dominated by disease-modifying therapies (DMTs), Eisai and Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab), which were approved by the FDA in January 2023 and July 2024, respectively.
According to GlobalData analysis, Leqembi and Kisunla are forecast to generate respective global sales of around $3.6bn and $3.8bn by 2033.
While Leqembi and Kisunla have ran into several market related issues since their FDA approval, including the UK’s National Institute for Health and Care Excellence (NICE) refusal to recommend either drug for use in the UK’s National Health Service (NHS) on the grounds of an unfavourable risk-benefit profile and poor cost-effectiveness, the treatments represent the most significant DMTs currently available for Alzheimer’s disease.
Also at AAIC, Roche announced new data from its pharmaceutical intervention trontinemab, which reduced amyloid levels below the 24 centiloid positivity threshold in 91% of patients after 28 weeks of treatment, with 72% achieving deep clearance below 11 centiloids in a Phase Ib/IIa trial.
