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Monoclonal Antibodies

Foralumab 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
Subject must meet NIA-AA Alzheimer's Disease Diagnostic Guidelines for Early Symptomatic Alzheimer's Disease with specific cognitive scores and memory performance
Age between 60 and 85 years
Must not have
Significant neurologic diseases including Parkinson's disease, stroke, dementia types, brain tumors, and others
Current treatment with specific drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to end of study, up to 20 weeks.
Awards & highlights

Summary

This trial will test the safety and effectiveness of Foralumab, a human antibody, in reducing inflammation in the brain to improve the immune response. The study will focus on participants with mild cognitive impairment

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
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I have been diagnosed with early symptomatic Alzheimer's according to specific guidelines.
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I am between 60 and 85 years old.
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I am not pregnant, breastfeeding, or able to become pregnant.
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I understand the study and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have significant neurological diseases like Parkinson's, stroke, or dementia.
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I am currently taking specific medications.
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I have had cancer in the last 3 years.
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I have a specific genetic variation in the TSPO gene.
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I currently have COVID-19.

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
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.

Find a Location

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
1,653 Previous Clinical Trials
11,491,019 Total Patients Enrolled
~11 spots leftby Jun 2026
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