Foralumab for Mild Cognitive Impairment in Alzheimer’s Disease

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

Recruiting Phase 2 Interventional Study
Dementia Alzheimers Disease Mild Cognitive Impairment Due to Alzheimer's Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
60 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
16 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for

This trial is looking for adults aged 60-85 with mild cognitive impairment due to Alzheimer's disease. Participants will take Foralumab through their nose three times a week for eight weeks and undergo various brain exams and tests.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have mild cognitive impairment due to Alzheimer's disease.
  • I am between 60 and 85 years old.
  • I am in good general health.
  • I have been on stable medications for eight weeks before the study.
  • I am not pregnant or breastfeeding.
  • I have an amyloid-positive PET scan.
  • I can understand and provide consent for the study.
  • I have a study partner who knows me well.

You may not be able to join if

  • I have a significant neurologic disease.
  • I have uncontrolled medical conditions.
  • I have a history of autoimmune disease.
  • I am currently taking immunosuppressive drugs.
  • I have had major depression in the past year.
  • I have a history of substance abuse in the past two years.
  • I have had cancer in the past three years.
  • I have an amyloid-negative PET scan.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. The Sponsor will rely on NIA-AA Alzheimer's Disease Diagnostic Guidelines for Early Symptomatic Alzheimer's Disease (AD) with a 20-30 MMSE score, Clinical Dementia Rating (CDR) global score of 0.5 or 1, and impaired memory performance below an education adjusted cut-off score…
Contacts

Gad Marshall, MD

617-525-6754

foralumab@mgb.org

CONTACT

Ryan de Lissovoy, BS

617-278-0831

foralumab@mgb.org

CONTACT