Study of Nasal Foralumab Safety and Brain Immune Activity in Older Adults With Early Alzheimers Disease

What this Trial Is About

Researchers are studying Foralumab, a nasal anti-CD3 antibody, to evaluate its safety, tolerability, and potential cognitive benefits in people aged 60 to 85 with mild cognitive impairment due to early Alzheimers disease or dementia. The study is a phase 2a randomized, double-blind, placebo-controlled trial designed to assess whether Foralumab can modulate brain immune cells called microglia to reduce inflammation and improve immune response in the brain, possibly impacting cognition. Participants will be randomly assigned to receive either 50 g or 100 g doses of nasal Foralumab or placebo in cycles. Each treatment cycle consists of nasal doses administered three times a week Monday, Wednesday, Friday for two consecutive weeks, followed by a one-week break. Subjects will complete four such cycles over three months. The study includes two cohorts with staggered enrollment and a 31 ratio of active drug to placebo. During the trial, participants will undergo brain scans including Amyloid PET and MRI, cognitive tests, blood draws for immune markers, and physical, neurological, and nasal exams. A lumbar puncture will be done at screening and after three months to assess brain protein changes. Safety labs and nasal exams will be performed regularly. The total participation lasts about six months, with monitoring of adverse events and immune function as primary outcomes.

Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease