MedTrace Logo

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

NCT06489548 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

  • Dementia
  • Alzheimers Disease
  • Mild Cognitive Impairment Due to Alzheimer's Disease

Interventions

DRUG

Foralumab TZLS-401 50 µg

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

DRUG

Foralumab TZLS-401 100 µg

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

Sponsors & Collaborators

  • Tiziana Life Sciences LTD

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489548 on ClinicalTrials.gov