Foralumab for Mild Cognitive Impairment

Overseen By Ryan de Lissovoy, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Neurologic disease, Uncontrolled hypertension, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Foralumab, a nasal spray, to determine its effectiveness for people with mild memory problems due to early Alzheimer's or dementia. The nasal spray aims to boost the brain’s immune response and reduce inflammation, potentially improving brain function. Participants will use the spray three times a week for a few months and undergo brain scans and tests. The study seeks individuals with mild memory issues linked to Alzheimer's who are generally in good health. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in Alzheimer's care.

Do I need to stop my current medications to join the trial?

The trial requires that you have been on a stable medication regimen for eight weeks before starting and that you remain stable during the study. However, you cannot be on immunomodulatory or immunosuppressive drugs or corticosteroids within the past month.

Is there any evidence suggesting that Foralumab is likely to be safe for humans?

Research shows that Foralumab, a type of human antibody, is being tested for safety and tolerance. In earlier studies with mice, Foralumab reduced brain inflammation, which is significant in diseases like Alzheimer's. Although information from human studies is still being collected, the FDA's approval for further research suggests no major safety concerns at this time.

In the current trials, participants will use Foralumab as a nasal spray. Researchers aim to determine if it can help with memory and thinking issues. The study will also carefully monitor for any side effects. Participants will undergo physical and neurological exams, along with brain scans, to ensure their safety. This close monitoring helps researchers understand how well people handle the treatment.

Since this is a Phase 2 study, Foralumab has already passed initial safety tests in earlier phases, indicating it is safe enough for further testing in humans. However, researchers will continue to watch for any negative effects as the study progresses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Foralumab for mild cognitive impairment because it offers a new approach by using a nasal spray delivery method. Unlike typical treatments that might involve oral medications or infusions, this method is non-invasive and targets the immune system directly through nasal administration. Foralumab is an anti-CD3 monoclonal antibody, which suggests it could modulate immune responses associated with cognitive decline, offering a novel mechanism of action compared to current therapies that primarily focus on symptom management. These unique features have the potential to change how we approach treating mild cognitive impairment, making it a promising candidate in the field.

What evidence suggests that Foralumab might be an effective treatment for mild cognitive impairment?

Research suggests that Foralumab, a type of medication, may help with mild memory problems caused by early Alzheimer's or dementia. Other studies have shown that Foralumab can reduce inflammation in the brain's main immune cells, called microglia. This reduction in inflammation is believed to improve brain function. Initial results from a study with a patient who had moderate Alzheimer's showed encouraging outcomes, specifically a decrease in brain inflammation after using Foralumab as a nasal spray. In this trial, participants will receive different dosages of Foralumab or a placebo. The treatment has been tested in humans with few side effects, indicating it could be a safe option for addressing memory issues related to dementia. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 60 and 85 years old.

Amyloid-positive PET scan

I understand the study and can give my consent.

Exclusion Criteria

Participation in another clinical trial concurrently or within the past 30 days

I have a specific genetic variation in the TSPO gene.

I do not have significant neurological diseases like Parkinson's, stroke, or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive nasal Foralumab three times a week for two weeks, followed by a one-week rest, repeated for a total of four cycles over three months

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PET scans and cognitive testing

8 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Foralumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm A: This cohort of subjects will receive 100µg/dosing day vs. placebo throughout the study. Active Control 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Tiziana Life Sciences LTD

Industry Sponsor

Trials

13

Recruited

310+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06489548

Study Details | NCT06489548 | Assessment of Foralumab ... This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.

2. tizianalifesciences.com tizianalifesciences.com/tiziana-life-sciences-announces-significant-reduction-in-microglia-activation-in-pet-scan-of-moderate-alzheimers-patient-treated-with-intranasal-foralumab/

Tiziana Life Sciences Announces Significant Reduction in ... Nasal foralumab, a fully human anti-CD3 monoclonal antibody, has shown efficacy in dampening microglial activation through the induction of ...

3. journals.lww.com journals.lww.com/nuclearmed/fulltext/2025/08000/dampening_of_microglial_activation_with_nasal.14.aspx

Dampening of Microglial Activation With Nasal Foralumab... A 78-year-old man with moderate Alzheimer disease (AD) dementia was treated with nasal-foralumab, a fully human anti-CD3 monoclonal antibody.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10500187/

Nasal administration of anti-CD3 monoclonal antibody ... Foralumab, a fully human anti-CD3 mAb, has been successfully given to human subjects and has demonstrated immune effects with minimal toxicity ( ...

5. seekingalpha.com seekingalpha.com/article/4794796-tiziana-scope-of-foralumab-goes-beyond-that-of-multiple-sclerosis-targeting

Tiziana: Scope Of Foralumab Goes Beyond That Of ... Tiziana (TLSA) is showing groundbreaking advancements in Alzheimer's & MS treatments with foralumab. Key trials & market insights reveal ...

6. tizianalifesciences.com tizianalifesciences.com/drug-pipeline/intranasal-foralumab/

Intranasal Foralumab The FDA has approved a Phase 2 trial to assess nasal Foralumab in Alzheimer's disease, focusing on safety, cognitive function, and microglial activation over a ...

7. ctv.veeva.com ctv.veeva.com/study/assessment-of-foralumab-safety-and-modulation-of-microglial-activation

Assessment of Foralumab Safety and Modulation of Microglial ... This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.

8. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06489548/

Trial | NCT06489548 This trial will evaluate whether nasal Foralumab can improve cognition in participants with mild cognitive impairment due to early Alzheimer's or dementia.

9. smartpatients.com smartpatients.com/trials/NCT06489548

Assessment of Foralumab Safety and Modulation ... 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 ...