Cognition Therapeutics’ dementia drug showed up to a 129% slowing of cognitive decline in mild Alzheimer’s disease patients in a Phase II trial.
In the Phase II SHINE study (NCT03507790), investigating zervimesine in patients with Alzheimer’s disease, the subgroup of patients saw marked slowing of cognitive deterioration.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The trial investigated a subgroup of patients whose Alzheimer’s disease brain pathology was less pronounced, as determined by lower levels of a protein called p-tau217 in their blood, with around half the group considered to have mild Alzheimer’s disease and half moderate Alzheimer’s disease.
In this group, zervimesine slowed further cognitive deterioration in patients with mild or moderate Alzheimer’s disease by 129% and 91%, respectively.
Cognition’s data was presented at the Alzheimer’s Association International Conference (AAIC) conference, taking place in Toronto, Canada, from 27-31 July.
Cognition is hopeful that it can easily determine Alzheimer’s disease patients most likely to benefit from zervimesine treatment through a p-tau217 blood test.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataSeveral p-tau217 tests have shown promise at AAIC, including ALZpath’s antibody that has been used in more than 150 scientific presentations and posters and 90 publications across 18 countries since its release in 2023. Roche also presented real-world data from Elecsys pTau217, a blood-based biomarker that received a breakthrough device designation from the US Food and Drug Administration (FDA) in April 2024.
In patients with lower p-tau-217, there were also significant reductions in the level of plasma glial fibrillary acidic protein (GFAP), a protein associated with neuroinflammation, and trends towards the normalisation of neurofilament light (NfL), a protein associated with neurodegeneration, and amyloid beta species (Aβ40 and 42).
Cognition VP of Research, Dr. Mary Hamby, said: “This is consistent with previously reported results showing significant decreases in NfL and normalising trends in amyloid beta species in the cerebrospinal fluid of people treated with zervimesine. This is encouraging evidence that zervimesine is impacting the underlying Alzheimer’s disease biology.”
Also at AAIC, Roche presented data from its Phase II trial of 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.
Data from DLB trial also presented
Cognition also presented data from the Phase II SHIMMER study (NCT05225415), investigating zervimesine in patients with dementia with Lewy bodies (DLB). Those treated with the study drug saw an improvement in neuropsychiatric, cognitive, motor, and functional scales.
After six months of treatment, zervimesine-treated patients scored an average of 86% better than those on placebo-treated patients on the neuropsychiatric inventory (NPI-12) which measures 12 separate behavioural symptoms, including hallucinations, delusions, and anxiety – key hallmarks of DLB. Cognition Therapeutics previously reported that the Phase II SHIMMER trial met its primary endpoint of safety and tolerability.
In these patients, hallucinations, delusions, and anxiety are often considered most troubling to both patients and carers, Dr. James Galvin, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, said.
“These behavioural symptoms are also some of the most challenging to treat, since DLB patients have severe and sometimes dangerous reactions to many commonly used neuropsychiatric drugs,” Galvin explained.
Growing interest from big pharma in Alzheimer’s disease
There has been a renewed interest by big pharma in Alzheimer’s disease in recent years, according to Alison Labya, Business Fundamentals Pharma Analyst at GlobalData.
“The US Food and Drug Administration (FDA) approvals of anti-Aβ monoclonal antibodies Eisai and Biogen’s Leqembi in January 2023, and Eli Lilly’s Kisunla in July 2024, have led to renewed interest in Alzheimer’s disease. Current Alzheimer’s R&D efforts now aim to improve efficacy and safety, including in the later stages of disease, by developing drugs targeting disease mechanisms beyond Aβ plaques,” Labya says.
GlobalData analysis shows that acquisitions involving Alzheimer’s disease innovator drugs surged in total deal value by more than 780%, increasing from $2bn in 2022 to almost $18bn in 2024.
This includes a $1.4bn acquisition of Aliada Therapeutics by AbbVie in December 2024, adding a Phase I Alzheimer’s asset to its portfolio, and a $14.6bn acquisition of neurology biotech Intra-Cellular Therapies by Johnson & Johnson (J&J) in April 2025.
Sanofi is also trying to find its way into the Alzheimer’s market with a $470m acquisition of Vigil Neuroscience, adding the oral TREM2 agonist VG-3927 to its pipeline.
Labya added: “Large pharmaceutical companies, such as AbbVie and Sanofi, are placing their bets on Alzheimer’s disease through high-value acquisitions. The future Alzheimer’s disease treatment paradigm is anticipated to be combinatorial, where novel drugs targeting alternative disease mechanisms, other than Aβ plaques, must demonstrate additive efficacy alongside Leqembi and Kisunla, as well as improved safety, to achieve market success.”
GlobalData is the parent company of Clinical Trials Arena.
