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Tests treatment safety and results for Dementia
Official title Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
ClinicalTrials.gov ID: NCT06489548
What this study is testing
What is Foralumab TZLS-401 50 µg?
Foralumab TZLS-401 50 µg is an investigational medicine, being studied as a potential treatment for dementia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85
You may be able to join if
- 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...
- 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...
You likely can't join if
- Any significant neurologic disease including Parkinson's disease, stroke, multiinfarct dementia, frontotemporal dementia, Lewy body dementia, normal...
- Clinically significant or unstable medical conditions, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary...
- History of autoimmune disease.
- Current treatment with immunomodulatory or immunosuppressive drugs or corticosteroid administration by any route of administration (including nasal...
- 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.
See the full eligibility criteria
- 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...
- 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...
- Amyloid-positive PET scan (performed only if the subject meets all other ). 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...
- 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.