Alzheimer Agent Blarcamesine Shows Significant Reduction of Amyloid-ß Biomarkers in Phase 2b/3 Trial
Newly announced findings from a follow-up analysis to the phase 2b/3 study (NCT03790709) assessing blarcamesine (Anavex Life Sciences), an investigational therapy, demonstrated a significant reduction in pathological amyloid-ß levels in plasma, as well as a significant slowing in the rate of pathological brain atrophy on MRI scans in treated patients with early AD.1
In the study, blarcamesine-treated patients showed significant increases in validated biomarkers of amyloid-ß pathology, plasma Aβ42/40 ratio (P = .048), further demonstrating the agent’s strong antiamyloid effect. Additionally, MRI findings showed significant reduction in brain volume loss, including whole brain (P = .0005), when blarcamesine was comparedwith placebo.
The trial was a multicenter, randomized, double-blind, placebo-controlled, phase 2b/3 study that enrolled 508 participants with early symptomatic AD. The participants, recruited from 52 medical research centers and hospitals in 5 countries, were randomized to receive blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks. The Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) subscales were used as primary end points to assess the cognitive and functional efficacy of blarcamesine. Using a mixed model for repeated measures, all prespecified clinical end points were analyzed.
Alzheimer Agent ALZ-801 Improves Cognition, Reduces Relevant Biomarker Levels in 2-Year Analysis
Alzheon, the drug makers of ALZ-801, announced positive topline data from its phase 2 biomarker study (NCT04693520), with findings that showed significant reductions in plasma phosphorylated tau (p-tau) levels and improved cognitive scores after 2 years of treatment with the agent. Patients on ALZ-801 also demonstrated a statistically significant reduction in measures of hippocampal volume in comparison with an external control arm of matched ADNI patients, which were consistent with previously reported 12-month data.2
The open-label, single-arm phase 2 trial included 84 patients with early-stage AD who carried either 1 or 2 copies of the ε4 allele of apolipoprotein E gene (APOE3/4 heterozygotes and APOE4/4 homozygotes, respectively) and were treated over a 104-week period. Treatment with the agent resulted in a statistically significant 43% reduction in plasma p-tau181 (P <.009) after 52 weeks and a 31% reduction at week 104 (P <.045). Plasma amyloid-ß42 levels decreased throughout the treatment period, reaching a statistically significant 4% reduction from baseline (P <.042) at week 104, while the reduction in plasma Aß40 levels stabilized at 52 weeks at a new homeostatic level.
After 104 weeks of treatment, patients showed a statistically significant 28% reduction in hippocampal volume (P <.015) in comparison with external controls from the Alzheimer Disease Neuroimaging Initiative (ADNI). Controls from the ADNI which were matched based on APOE4 genotype, age, gender, and disease stage following FDA guidance from August 2023 on the use of real-world data and real-world evidence to support regulatory decision-making for drugs and biological products.
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