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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06489548
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Foralumab TZLS-401 50 µg — DRUG
    Foralumab is a nasal anti-CD3 antibody. It will be administered in doses of 50 µg vs. placebo.
  • Foralumab TZLS-401 100 µg — DRUG
    Foralumab is a nasal anti-CD3 antibody. It will be administered in doses of 100 µg vs. placebo.

Study Details

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.

Key Dates

Start date
Sep 16, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: This cohort of subjects will receive 100µg/dosing day vs. placebo throughout the study.
    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.
  • Active Comparator: Arm B: This cohort of subjects will receive 50µg/dosing day vs. placebo throughout the study.
    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.

Primary Outcome Measure

The number of adverse events in drug versus placebo groups. [ Time Frame: From baseline to the end of study, up to 20 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Alzheimer Research and Treatment, Brigham and Women's HospitalBostonMassachusetts02115
Gad Marshall, MD
[email protected]
617-525-6754

Find similar trials in Boston, MA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Center for Alzheimer Research and Treatment, Brigham and Women's Hospital· Boston, MA

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