Actively Recruiting

Phase 2
Age: 60Years - 85Years
All Genders
ID06489548

Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients With Early Symptomatic Alzheimer's Disease

Led by Brigham and Women's Hospital · Updated on 2026-02-12

16

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

T

Tiziana Life Sciences LTD

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying Foralumab, a nasal anti-CD3 antibody, to evaluate its safety, tolerability, and potential cognitive benefits in people aged 60 to 85 with mild cognitive impairment due to early Alzheimer's disease or dementia. The study is a phase 2a randomized, double-blind, placebo-controlled trial designed to assess whether Foralumab can modulate brain immune cells called microglia to reduce inflammation and improve immune response in the brain, possibly impacting cognition. Participants will be randomly assigned to receive either 50 µg or 100 µg doses of nasal Foralumab or placebo in cycles. Each treatment cycle consists of nasal doses administered three times a week (Monday, Wednesday, Friday) for two consecutive weeks, followed by a one-week break. Subjects will complete four such cycles over three months. The study includes two cohorts with staggered enrollment and a 3:1 ratio of active drug to placebo. During the trial, participants will undergo brain scans including Amyloid PET and MRI, cognitive tests, blood draws for immune markers, and physical, neurological, and nasal exams. A lumbar puncture will be done at screening and after three months to assess brain protein changes. Safety labs and nasal exams will be performed regularly. The total participation lasts about six months, with monitoring of adverse events and immune function as primary outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with early symptomatic Alzheimer's disease according to NIA-AA guidelines with specific cognitive scores (MMSE 20-30, CDR 0.5 or 1, impaired memory on Logical Memory II subscale).
  • Age between 60 and 85 years inclusive.
  • Good general health without diseases likely to interfere with study assessments.
  • On a stable medication regimen for at least eight weeks prior to study and expected to remain stable.
  • Not pregnant, lactating, or of childbearing potential; women must be two years post-menopausal or surgically sterile, or partner must use barrier contraception.
  • Amyloid-positive PET scan confirming eligibility.
  • Ability to understand and provide informed consent.
  • Availability of a study partner who knows the participant well and has regular contact.
Not Eligible

You will not qualify if you...

  • Significant neurologic diseases such as Parkinson's, stroke, multiple sclerosis, brain tumors, or history of significant head trauma with lasting deficits.
  • Unstable medical conditions including uncontrolled hypertension, diabetes, or serious cardiac, pulmonary, renal, hepatic, endocrine, or systemic diseases.
  • History of autoimmune disease.
  • Use of immunomodulatory or immunosuppressive drugs or corticosteroids within the past month.
  • Major depressive disorder within the past year, history of bipolar disorder or schizophrenia.
  • Alcohol or substance abuse within the past two years.
  • History of malignancy within the past three years.
  • Clinically significant lab abnormalities.
  • Participation in another investigational drug trial within the past 30 days.
  • Low affinity TSPO binders determined at screening.
  • Sensitivity to florbetapir F18.
  • Active COVID-19 infection.
  • Amyloid-negative PET scan.
  • COVID-19 vaccine within past ten days or any other vaccine within past seven days at dosing.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

2 visits including laboratory tests, cognitive and neurological exams, lumbar puncture, and amyloid PET scan if not previously done

Treatment

Duration - 3 months

Participants receive nasal Foralumab or placebo three times a week for two weeks followed by a one-week rest. This cycle repeats for a total of four cycles over three months.

3 dosing visits per week for 2 weeks followed by 1 rest week, repeated 4 times; nasal exams and safety labs prior to each cycle and at end of treatment

Follow-up

Duration - Up to 2 weeks after treatment

Participants undergo final assessments including blood samples, MRI, microglial PET scan, and lumbar puncture to evaluate treatment effects.

1 follow-up visit for final imaging and sample collection

Trial Site Locations

Total: 1 location

1

Center for Alzheimer Research and Treatment, Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

G

Gad Marshall, MD

R

Ryan de Lissovoy, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Nasal anti-CD3 antibody ameliorates lupus by inducing an IL-10-secreting CD4+ CD25- LAP+ regulatory T cell and is associated with down-regulation of IL-17+ CD4+ ICOS+ CXCR5+ follicular helper T cells.

Henry Yim Wu, Francisco J Quintana, Howard L Weiner

https://pubmed.ncbi.nlm.nih.gov/18941193

MHC-independent genetic factors control the magnitude of CD4+ T cell responses to amyloid-β peptide in mice through regulatory T cell-mediated inhibition.

Cécile Toly-Ndour, Gabrielle Lui, Maria Manuel Nunes...

https://pubmed.ncbi.nlm.nih.gov/21949026

Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice.

Mineko Ogura, Songyan Deng, Paula Preston-Hurlburt...

https://pubmed.ncbi.nlm.nih.gov/28739191

Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study.

Thais G Moreira, Kimble T F Matos, Giovana S De Paula...

https://pubmed.ncbi.nlm.nih.gov/34475873

IL-10-dependent Tr1 cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation.

Lior Mayo, Andre Pires Da Cunha, Asaf Madi...

https://pubmed.ncbi.nlm.nih.gov/27246324

The TREM2-APOE Pathway Drives the Transcriptional Phenotype of Dysfunctional Microglia in Neurodegenerative Diseases.

Susanne Krasemann, Charlotte Madore, Ron Cialic...

https://pubmed.ncbi.nlm.nih.gov/28930663