RecruitingPhase 2NCT06489548

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

Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients With Early Symptomatic Alzheimer's Disease


Sponsor

Brigham and Women's Hospital

Enrollment

16 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase 2a study will research the safety and tolerability of Foralumab, a human anti-CD3 antibody. An antibody is a molecule secreted by the immune system. These molecules are created to identify a specific pathogen. Previous data on experimental mice has suggested that Foralumab increases the immune system activity in the brain to reduce the inflammation of microglia, the brain's main immune cells. This combination of increased immune reactivity and less microglia inflammation may improve the immune response throughout the brain. Alzheimer's disease and other forms of dementia are characteristically known for the build-up of certain proteins in the brain. This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia. The trial will ask participants to administer Foralumab nasally three times a week for eight weeks. The administration will occur intermittently, with breaks between each dosing cycle. Participants will also receive brain scans (Amyloid PET and MRI), undergo cognitive testing, blood draws, and physical, neurological, and nasal exams. Volunteers are expected to remain in the trial for six months.


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing foralumab — an experimental drug given as a nasal spray — in people with early-stage Alzheimer's disease. Researchers believe it may calm inflammation in the brain by targeting immune cells called microglia. The study will use brain scans to see if this drug reduces brain inflammation. **You may be eligible if...** - You are between 60 and 85 years old with a diagnosis of early symptomatic Alzheimer's disease - Your memory test scores fall within the early symptomatic range (MMSE 20–30) - You are generally in good health otherwise **You may NOT be eligible if...** - You have moderate or advanced Alzheimer's disease - You have other significant brain or neurological conditions - You have major organ disease (heart, liver, kidney) that could interfere with the study - You are on medications that could interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGForalumab TZLS-401 50 µg

Foralumab is a nasal anti-CD3 antibody. It will be administered in doses of 50 µg vs. placebo.

DRUGForalumab TZLS-401 100 µg

Foralumab is a nasal anti-CD3 antibody. It will be administered in doses of 100 µg vs. placebo.


Locations(1)

Center for Alzheimer Research and Treatment, Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT06489548


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