Status:
NOT_YET_RECRUITING
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Tiziana Life Sciences LTD
Conditions:
Dementia
Alzheimers Disease
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Preliminary data has shown that Foralumab, a human anti-CD3 antibody, may improve cognition in APP/PS1and 3xTg mouse models of AD. Nasal Foralumab has been given to healthy volunteers with progressive...
Eligibility Criteria
Inclusion
- 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 on the Logical Memory II subscale delayed paragraph recall (LM-IIa) of the Wechsler Memory Scale- Revised (WMS-R) (127) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2).
- Age between 60 and 85 years (inclusive).
- Good general health with no disease likely to interfere with the study assessments.
- On a stable medication regimen for eight weeks prior to the study and is anticipated to remain stable during the study.
- Subject is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile). If a woman is of childbearing potential, her partner must use barrier contraception throughout the study.
- Amyloid-positive PET scan (performed only if the subject meets all other inclusion criteria). An amyloid-positive PET scan is classified by an SUVR composite score cutoff of 1.18 units. Prior evidence of amyloid positivity by PET or CSF will also be accepted for eligibility.
- Ability to understand and provide informed consent.
- Has availability of a study partner who has regular contact with the participant and knows him/her well.
Exclusion
- Any significant neurologic disease including Parkinson's disease, stroke, multiinfarct dementia, frontotemporal dementia, Lewy body dementia, normal pressure hydrocephalus, brain tumor, brain hemorrhage with persistent neurologic deficits, progressive supra-nuclear palsy, seizure disorder, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- Clinically significant or unstable medical conditions, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases.
- History of autoimmune disease.
- Current treatment with immunomodulatory or immunosuppressive drugs or corticosteroid administration by any route of administration (including nasal corticosteroids) within the past month.
- Major depressive disorder (within the past 1 year), or a history of bipolar disorder, or a history of schizophrenia.
- History of alcohol or substance abuse or dependence within the past two years.
- History of malignancy within the past 3 years.
- Clinically significant abnormalities in screening laboratories (defined as greater than mild on the FDA's vaccine toxicity grading scale).
- Participation in another clinical trial of an investigational drug concurrently or within the past 30 days.
- Low affinity TSPO binders (for PET ligand \[18F\]PBR06) determined by having a Thr/Thr polymorphism in the TSPO gene at screening.
- Sensitivity to florbetapir F18.
- Active COVID-19 disease.
- Amyloid-negative PET scan.
- COVID-19 vaccine within the past ten days or any other vaccine within the past seven days (at dosing)
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06489548
Start Date
April 1 2025
End Date
December 1 2026
Last Update
January 31 2025
Active Locations (1)
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1
Center for Alzheimer Research and Treatment, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115