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Monoclonal Antibodies

Foralumab TZLS-401 50 µg for Mild Cognitive Impairment

Phase 2
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. The Sponsor will rely on NIA-AA Alzheimer's Disease Diagnostic Guidelines for Early Symptomatic Alzheimer's Disease (AD) with a 20-30 MMSE score, Clinical Dementia Rating (CDR) global score of 0.5 or 1, and impaired memory performance below an education adjusted cut-off score on the Logical Memory II subscale delayed paragraph recall (LM-IIa) of the Wechsler Memory Scale- Revised (WMS-R) (127) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2).
2. Age between 60 and 85 years (inclusive).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to end of study, up to 20 weeks.
Awards & highlights

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.

Who is the study for?
This trial is for individuals with early Alzheimer's, mild cognitive impairment, or dementia. Participants will use Foralumab nasally and must be willing to undergo brain scans, cognitive tests, and regular health exams over six months.
What is being tested?
The study is testing the safety of Foralumab at two doses (50 µg and 100 µg) administered nasally. It aims to see if it can improve brain immune response and cognition by reducing inflammation in microglial cells.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to immune system activation or nasal administration since Foralumab is an antibody that targets the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to end of study, up to 20 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to end of study, up to 20 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of microglial function via PET scan using the ligand [18F]PBR06
Measure the effect of foralumab on the ratio of CD4/CD8 memory/naïve T cells biomarkers in blood
The number of adverse events in drug versus placebo groups.

Trial Design

2Treatment groups
Active Control
Group I: Arm A: This cohort of subjects will receive 100µg/dosing day vs. placebo throughout the study.Active Control1 Intervention
This group will receive a nasal spray three times a week for two weeks, followed by a one-week rest. That cycle will occur three more times for a total of three months of drug intervention.
Group II: Arm B: This cohort of subjects will receive 50µg/dosing day vs. placebo throughout the study.Active Control1 Intervention
This group will receive a nasal spray three times a week for two weeks, followed by a one-week rest. That cycle will occur three more times for a total of three months of drug intervention.

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Who is running the clinical trial?

Tiziana Life Sciences LTDIndustry Sponsor
9 Previous Clinical Trials
215 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,650 Previous Clinical Trials
11,481,274 Total Patients Enrolled
~11 spots leftby Jun 2026
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