Oct. 31, 2023 Repost from Business Wire and Firstword Healthtech -- Cognito Therapeutics announced on Tuesday that its GammaSense wearable stimulation device demonstrated durability and concordance of clinical and magnetic resonance imaging (MRI) benefits over 18 months in patients with mild-to-moderate Alzheimer’s disease (AD). Results from the Phase II open-label extension (OLE) study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference.
"Our therapy significantly preserves brain volume over time, with less observation of brain atrophy," remarked chief medical officer Ralph Kern, adding the findings show "potential for use as a mono-therapy or as adjunctive therapy in combination."
The company first reported data from the randomised Phase II OVERTURE study in 2021. Participants who completed the six-month trial were eligible to receive one-hour of treatment daily for an extra 12 months in the OLE study. Of the 53 volunteers who completed the six-month trial, 44 patients entered the extension study, with 22 completing all study assessments.
No ARIA or treatment-limiting SAEs
The OLE study confirmed safety, tolerability and high adherence to Cognito's neuromodulation therapy, with no amyloid-related imaging abnormalities (ARIA) or treatment-limited serious adverse events (SAEs) reported. The most common adverse events seen in the randomised controlled trial (RCT) were headache and tinnitus. Cognito said safety outcomes with the active device remained consistent through the 18-month period.
Meanwhile, patients who participated in the OLE portion of the study showed 80% adherence in both the active device group and those randomised to sham who switched to the active device. Clinical stability of function as measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was also maintained following treatment with the active device at 18 months, the company said.
Lower rate of brain atrophy
Compared to the sham treatment, GammaSense was associated with patients experiencing >15% decline in ADCS-ADL total score for a longer period of time – roughly 422 mean days versus about 151 mean days, respectively. In addition, continued treatment with GammaSense demonstrated a lower rate of brain atrophy than observed in the sham arm in both the RCT and OLE. Further, early- and delayed-start model data showed comparable estimated ADCS-ADL and whole-brain volume 18-month slopes, while disease modification analysis demonstrated that statistically significant separation was maintained during the OLE.
Cognito's system, which secured an FDA breakthrough device designation in 2021, is also being investigated in the HOPE trial to treat cognitive and functional symptoms in patients with mild-to-moderate Alzheimer's disease. In March, the company pocketed $73 million in Series B financing to advance the ongoing pivotal study.
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