US cognitive health company Bevimi awarded up to $2m for Alzheimer’s research

Bevimi has been selected for up to US$2m in funding to study early cognitive changes and biological processes linked to Alzheimer’s disease.

The funding will support an 18-month research programme examining subjective cognitive decline, where people notice changes in memory or thinking without necessarily having a diagnosed cognitive condition.

Known as PS36-PRISMM, the programme will include a 24-week randomised, double-blind, placebo-controlled study involving 150 US adults aged 45 to 70 who report subjective cognitive decline.

Joel Dudley, co-founder and president of Bevimi, said: “We bring a level of clinical and scientific rigour to consumer cognitive health that has historically been uncommon in the supplement industry.”

“ARPA-H’s support gives us the opportunity to demonstrate that approach at meaningful scale – studying people earlier, measuring biology deeply over time and generating evidence through a randomised, independently analysed clinical study.”

Researchers will investigate whether repeated biological measurements, cognitive assessments and behavioural data can help identify changes associated with early cognitive decline.

The study will also evaluate Bevimi’s Uno Protect, a once-daily nutritional beverage, although its effects have yet to be established through the planned research.

Participants will be monitored largely remotely, with blood samples collected at designated sites or by mobile healthcare professionals. They will also complete remote cognitive assessments and regular digital check-ins.

The research is supported by the Advanced Research Projects Agency for Health (ARPA-H), an agency within the US Department of Health and Human Services.

Researchers plan to collect more than 15,000 molecular measurements per participant at the start of the study and at weeks 12 and 24.

These will include proteomic profiling, which examines proteins in biological samples, and blood biomarkers associated with neurological changes.

One marker being assessed is p-tau217, which is associated with amyloid and tau pathology, biological changes linked to Alzheimer’s disease.

Other measurements include GFAP and NfL blood biomarkers, APOE genotyping and analysis of the oral and gut microbiome, the communities of microorganisms living in the mouth and digestive system.

The study will also examine immune signalling, lipid transport and cellular energy production.

The study will use a preregistered statistical analysis, with its predictions and analytical approach established before researchers know which participants received the nutritional beverage or placebo.

Independent clinical research organisation People Science is expected to conduct the analysis rather than Bevimi.

Alongside evaluating the nutritional intervention, the programme will produce a research dataset combining cognitive, genomic, protein, biomarker and microbiome measurements collected over time.

Bevimi plans to provide a de-identified dataset, a research methods guide and a comparison of three protein analysis platforms to an ARPA-H research repository.

These resources are intended to support future decentralised clinical studies and multi-omic research, which examines several types of biological information together.

Glen Coppersmith, director of ARPA-H’s Proactive Health Office, said: “ARPA-H is focused on solving the most difficult challenges in health. The PRISMM project is designed to combine decentralised clinical research with deep longitudinal biological measurement to generate new data on cognitive change before a clinical diagnosis.

“We look forward to seeing what the research reveals and how the resulting data and methods can bring us closer to a cure.”