Ralph Carmona was enrolled into a clinical trial of Leqembi in 2015. Image credit: meeboonstudio / Shutterstock.

US med-tech manufacturer Cognito Therapeutics has announced positive open-label extension (OLE) data from the Phase II trial of a proprietary gamma sensory stimulation device (CogTx-001) to treat mild-to-moderate Alzheimer’s disease. 

The Phase II OVERTURE study (NCT03556280) is a randomised controlled trial (RCT) to assess patients over an 18-month period, observing Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) and whole brain volume (WBV) decline. 

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The OVERTURE study treatment group participants received one hour of Cognito’s daily 40Hz simultaneous auditory-visual sensory stimulation at home for a six-month period with placebo group participants receiving sham stimulation. Patients who completed the six months were given the option to receive treatment for an additional 12 months. Of the 53 patients enrolled in the initial six months, 44 entered the OLE. 

Data collected over 18 months showed that the device reduces brain atrophy and ADCS-ADL decline, with no amyloid-related imaging abnormalities (ARIA) or treatment-limited serious adverse events. 

Chair of the medical advisory board for Cognito Therapeutics Marwan Sabbagh said: “Cognito’s potential DMT will be instrumental to help mitigate the accelerated brain atrophy caused by anti-amyloid monoclonal antibodies, with no ARIA shown over 18 months in the Phase II OLE data.”  

The FDA granted cognito breakthrough device designation (BDD) for their investigational medical device in 2021. The company intends to investigate the efficacy of the device further in the ongoing HOPE study (NCT05637801), which is a randomised, double-blind trial where 530 Alzheimer’s patients will receive daily treatment for 12 months with either active or sham sensory stimulation systems. Efficacy will be measured using the ADCS-ADL assessment.  

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In March 2023, Cognito secured $73m in a Series B financing round to advance its device for Alzheimer’s disease, with contributions from investors such as Alzheimer’s Drug Discovery Foundation, Starbloom Capital and IAG Capital, as well as WS Investment Company, the venture arm of Wilson Sonsini.