Actively Recruiting
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
Led by Brigham and Women's Hospital · Updated on 2026-02-12
16
Participants Needed
1
Research Sites
63 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
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.
CONDITIONS
Official Title
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of early symptomatic Alzheimer's disease with MMSE score 20-30 and Clinical Dementia Rating global score 0.5 or 1
- Memory impairment confirmed by Logical Memory II delayed recall test below education-adjusted cut-off
- Age between 60 and 85 years inclusive
- Good general health without diseases interfering with study assessments
- On stable medication regimen for at least eight weeks prior and expected to remain stable
- Not pregnant, lactating, or of childbearing potential; if of childbearing potential, partner uses barrier contraception
- Amyloid-positive PET scan or prior amyloid positivity evidence
- Ability to understand and provide informed consent
- Availability of a study partner with regular contact who knows the participant well
You will not qualify if you...
- Significant neurologic diseases such as Parkinson's, stroke, multiinfarct dementia, frontotemporal dementia, Lewy body dementia, normal pressure hydrocephalus, brain tumor, brain hemorrhage with persistent deficits, progressive supra-nuclear palsy, seizure disorder, multiple sclerosis, or major head trauma with persistent deficits
- Clinically significant or unstable medical conditions including uncontrolled hypertension, diabetes, cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases
- History of autoimmune disease
- Use of immunomodulatory or immunosuppressive drugs or corticosteroids (including nasal) within past month
- Major depressive disorder in past year, history of bipolar disorder or schizophrenia
- Alcohol or substance abuse within past two years
- Malignancy within past three years
- Clinically significant lab abnormalities above mild grading
- Participation in another investigational drug trial within past 30 days
- Low affinity TSPO binders determined by genetic test
- 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
AI-Powered Screening
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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
Research Team
G
Gad Marshall, MD
CONTACT
R
Ryan de Lissovoy, BS
CONTACT
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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