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

16 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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 Criteria

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

Amyloid-positive PET scan

I have been diagnosed with early symptomatic Alzheimer's according to specific guidelines.

I am between 60 and 85 years old.

Exclusion Criteria

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

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

I am currently taking specific medications.

Timeline

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)

Treatment Details

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.

Participant Groups

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+