New Research and Pipeline Updates at Alzheimer’s Conference

A brain imaging study from Wake Forest University School of Medicine published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions (DOI: 10.1002/trc2.70123) confirms that insulin—delivered via a simple nasal spray—safely and effectively reaches key memory regions of the brain in older adults. The study also revealed that people with early cognitive decline absorb it differently. The study used positron emission tomography (PET) imaging to directly shows that intranasal insulin travels to 11 key brain regions associated with memory and cognition. Previously, researchers faced challenges in earlier intranasal insulin trials because they couldn’t confirm if the treatment was reaching its brain targets.

Nautilus Biotechnology and the Allen Institute have entered into an agreement to investigate the connection between the tau protein and neurodegenerative conditions such as Alzheimer’s disease. While little is currently known about tau proteoforms — the many functional variants of tau — and how they influence Alzheimer’s disease progression, recent studies suggest that the order, timing, and extent of tau phosphorylation play critical roles in the disease. As part of this agreement, Nautilus and the Allen Institute aim to identify novel tau proteoforms from human brain tissue, quantify their prevalence, and characterize patterns of phosphorylation that may help predict the course of the disease. Nautilus’ recent preprint, “Development of a method for large-scale single-molecule analysis of tau proteoforms” (bioRxiv DOI: 10.1101/2025.06.26.660445), details the real-world capabilities of its proteomics platform to achieve an unprecedented level of resolution, providing actionable biological insights from studying brain samples of cognitively normal and impaired patients with Alzheimer’s. The company’s studies present initial validation of the accuracy, sensitivity, dynamic range, and reproducibility of Iterative Mapping for interrogating millions to billions of single-protein molecules in a scalable, adaptable manner. Press release.

Quanterix Corporation announced the first to market, commercial launch of two novel phospho-tau assays, p‑Tau 205 and p‑Tau 212, expanding its market-leading portfolio of blood-based biomarkers for Alzheimer’s disease and neurodegeneration. These new assays enable the precise detection of tau phosphorylation sites, biomarkers increasingly associated with early and progressive stages of Alzheimer’s disease. Developed on Quanterix’s ultra-sensitive Simoa platform, the p‑Tau 205 and 212 assays empower researchers to explore novel disease mechanisms, refine patient stratification, and support therapeutic development through fluid-based biomarkers. Quanterix’s growing leadership in neurobiology was further reinforced by its recent acquisition of Akoya Biosciences, bringing advanced spatial proteomics into its scientific ecosystem. The Human FFPE Neurobiology Panel, originally developed by Akoya, complements the Simoa platform by enabling high-plex, spatially resolved analysis of disease-specific protein expression in brain tissue. Together, these platforms offer researchers a powerful combination of tissue- and fluid-based biomarker discovery to accelerate translation from bench to bedside. Press release.

Anavex Life Sciences announced their latest findings for blarcamesine, an oral small molecule for the potential treatment of early Alzheimer’s disease. The ATTENTION-AD open-label extension Phase IIb/III treatment trial followed the 48-week clinical trial, with a combined duration of up to 192 weeks. The trial was designed to evaluate the safety and tolerability of blarcamesine as well as its long-term effects on cognition and function in participants with early Alzheimer’s disease. Blarcamesine-treated patients continue to accrue benefit through up to 4 years on cognition and function. In the intent-to-treat population, delayed-start analysis of treatment with oral blarcamesine was significant for both cognition and function, reflecting the importance of early treatment initiation. Press release.

Researchers and advisors to Linus Health have published work highlighting how efficiently digital assessments can uncover the earliest signs of cognitive impairment—likely years before traditional testing methods or noticeable symptoms emerge. Published in the Journal of Alzheimer's Disease, the findings demonstrate how a 7-minute speech-based digital cognitive assessment from Linus Health captures quantifiable data on neurodegenerative disease risk based on patients' process of answering questions and test prompts. In the peer-reviewed article, the authors introduce a series of novel digital biomarkers based on latency—the pauses and reaction times between actions—when responding to questions or test prompts. They describe how subtle changes in the time required to respond—even when answers are correct—can be interpreted as biomarkers for identifying the risk of mild cognitive impairment (MCI), Alzheimer's disease and other forms of dementia. Press release.

Cognito Therapeutics presented five posters last week supporting the clinical efficacy and neuroprotective mechanism of its lead investigational therapy, Spectris, in patients with Alzheimer’s disease. Spectris is a non-invasive, at-home device used for an hour a day, that uses synchronized light and sound sensory stimulation to evoke brain gamma oscillations. The company presented data showing that combining light and sound stimulation generates stronger gamma oscillations across more brain regions than either light or sound alone, and Spectris had more than 85% of participants adhering to the daily sessions. Results from the OVERTURE study showed Spectris preserved white matter and myelin integrity across multiple brain regions, indicating structural neuroprotection. These findings align with AD preclinical models demonstrating brain structure preservation following non-invasive gamma stimulation. In the OVERTURE open label extension (OLE), participants treated with Spectris experienced up to 9.9 months of “time saved” across clinical and imaging endpoints. Press release.

AltPep Corporation presented preclinical data reinforcing the promising potential of its lead compound, SOBIN-AD (Soluble Oligomer Binding INhibitor), as a treatment for early Alzheimer’s disease. SOBIN-AD binds Aβ oligomers 27,000-fold stronger than protofibrils; enhances microglial phagocytosis of toxic Aβ oligomers in a dose-dependent manner; significantly improves short-term memory in 9-month old Tg2576 AD mice after 6 months of dosing, 3X/week intranasally; and significantly reduces AB plaque burden in 15-month-old AD mice after 12 months of dosing, 3X/week intranasally the company reports. Press release.            

NKGen Biotech, focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, shared an update on the mechanism of action for Troculeucel, a first-in-kind, autologous, non-genetically modified NK cell product with significantly increased cytotoxicity and over 90% activating receptor expression that can be consistently produced from any donor. Preclinical and clinical trial data on the effect of troculeucel from two Phase 1 studies (NCT04678453 and NCT06189963) were presented to highlight the mechanism of action and confirmatory biomarker data from 13 patients with Alzheimer’s disease. Elevated levels of chemokine CXCL9, CXCL10, and CXCL11 have been detected in cerebrospinal fluid (“CSF”) during neuroinflammatory conditions. These ligands bind to the chemokine receptor CXCR3 and are believed to be locally produced by CNS-resident cells, including astrocytes and microglia, in response to inflammatory signals associated with protein deposition. In AD, the accumulation of misfolded proteins elicits a cascade of autoreactive T-cell mediated neuroinflammation and neuronal damage. These T cells have been shown to exhibit high CXCR3 chemokine receptor expression enabling them to cross the BBB. Troculeucel is a highly enhanced activated NK cell therapy with 91.25% CXCR3 expression and demonstrating strong chemotactic migration potential toward CSF from AD patients. Press release.

OncoC4 shared preclinical data that highlight the potential of ONC-841, a novel immune checkpoint inhibitor, in treating Alzheimer’s disease. ONC-841 is a first-in-class, clinical stage anti-SIGLEC 10 monoclonal antibody currently under development for the treatment of both solid tumors and AD. The SIGLEC 10-CD24 pathway, an innate immune checkpoint, is implicated in cancer evasion of host immunity, which OncoC4 has been exploring for cancer treatment. The preclinical findings from two AD models highlight the potential of ONC-841 as a first-in-class immunotherapy for neurodegeneration. Press release.

Roche received CE Mark for its Elecsys pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative. Press release. The company shared shared new data from its Alzheimer’s development portfolio including the latest results from the ongoing Phase Ib/IIa Brainshuttle AD study, which continue to support rapid and robust reduction of amyloid plaques, and design of the Phase III TRONTIER 1 and 2 studies of investigational trontinemab for early symptomatic Alzheimer’s disease, with initiation planned later this year. Roche has also announced its plans for an additional Phase III trial to investigate trontinemab in preclinical Alzheimer’s disease. The trial will focus on individuals at risk of cognitive decline, with the goal of potentially delaying or preventing the progression of the disease to symptomatic stages. Press release.

Eisai presented the latest findings from its Alzheimer's disease pipeline and research, including its dual-acting, anti-amyloid beta (AB) protofibril antibody for the treatment of AD, lecanemab, and anti-MTBR (microtubule binding region) tau antibody, etalanetug (E2814). Eisai also shared preliminary results from the DIAN-TU-001 NexGen Trial, exploring etalanetug with background lecanemab therapy to slow or prevent the progression of Alzheimer’s disease. As we gain more experience using dual-acting lecanemab in different clinical settings and continue to explore new avenues to improve the diagnosis and treatment of Alzheimer’s disease, we are hopeful about the future. We remain committed to patients and their loved ones who are impacted by this progressive, relentless disease, caused by a continuous underlying neurotoxic process that begins before and continues after plaque is removed from the brain. Press release.

Biogen shared data on LEQEMBI (lecanemab) including 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau explored tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau. Press release.

Cognition Therapeutics shared results from the Phase 2 ‘SHIMMER’ study of zervimesine (CT1812) in dementia with Lewy bodies (DLB). DLB is the second most common cause of dementia, affecting approximately 1.4 million Americans. People living with DLB experience a variety of symptoms, which typically include neuropsychiatric features such as hallucinations, delusions, and agitation; cognitive impairment; Parkinsonian movement disorders; REM sleep behavior disorder; and fluctuations in attention and awareness. Currently no disease-modifying therapeutics are approved for DLB. Press release.