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RecruitingPhase 2

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

Assessment of Foralumab Safety and Modulation of Microglial Activation Evaluated by PET Imaging in Patients With Early Symptomatic Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks, 6 months
  • Procedures mentioned: Blood draws, MRI scans, Physical exams, PET scans, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The trial will ask participants to administer Foralumab nasally three times a week for eight weeks."
  • "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."
  • "Subjects will undergo screening procedures, including laboratory studies (hematology, clinical chemistry, CRP, EBV serology, HIV testing, Hepatitis B and Hepatitis C), vital signs, cognitive testing, and a complete physical exam by the physician investigator or a mid-level practitioner, and a detailed neurologic examination performed by a neurologist."
  • "At baseline and end of treatment, each subject will have blood samples collected for immunological study and undergo an MRI and a microglial PET scan."
  • "Blood samples for immunologic studies will be collected at baseline and after 3 months of treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of foralumab given through the nose and whether it may help memory and thinking in people with early Alzheimer's disease. It is for adults ages 60 to 85 who meet the study's memory test and brain protein test rules. Treatment lasts eight weeks with breaks, and participants stay in the study for six months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 60 to 85 years old.
  • Have early Alzheimer's disease and meet the study's required scores on memory, thinking, and dementia tests.
  • Be in good general health, with no illness that would affect study tests.
  • Have taken the same medicines at stable doses for eight weeks and expect no changes during the study.
  • Not be pregnant or breastfeeding. Women must be at least two years past menopause or have surgery that prevents pregnancy; if able to become pregnant, their partner must use barrier birth control.
  • Have a positive test for amyloid, a protein that builds up in Alzheimer's disease. A study PET brain scan or past positive PET or spinal fluid test can qualify.
  • Be able to understand the study and agree to take part.
  • Have a study partner who knows you well and has regular contact with you.

Who can't join

  • Have another major brain or nerve disease, such as Parkinson's, stroke, seizures, or another type of dementia; or lasting problems from a serious head injury.
  • Have a serious or unstable illness, such as uncontrolled blood pressure or diabetes, or significant problems on screening lab tests.
  • Have a history of autoimmune disease, where the immune system attacks the body; take medicines that change or weaken the immune system; or have used steroids by any route, including the nose, in the past month.
  • Have had major depression in the past year, bipolar disorder or schizophrenia at any time, or alcohol or drug abuse or dependence in the past two years.
  • Have had cancer in the past three years, or take part in another study of an experimental drug now or within the past 30 days.
  • Have a specific TSPO gene pattern that makes the study's PET scan tracer bind poorly, sensitivity to the scan drug florbetapir F18, or a negative amyloid PET scan.
  • Have active COVID-19.
  • Have received a COVID-19 vaccine within 10 days or another vaccine within seven days before dosing.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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). 2. Age between 60 and 85 years (inclusive). 3. Good general health with no disease likely to interfere with the study assessments. 4. On a stable medication regimen for eight weeks prior to the study and is anticipated to remain stable during the study. 5. 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. 6. 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. 7. Ability to understand and provide informed consent. 8. Has availability of a study partner who has regular contact with the participant and knows him/her well. Exclusion Criteria: 1. 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. 2. Clinically significant or unstable medical conditions, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases. 3. History of autoimmune disease. 4. Current treatment with immunomodulatory or immunosuppressive drugs or corticosteroid administration by any route of administration (including nasal corticosteroids) within the past month. 5. Major depressive disorder (within the past 1 year), or a history of bipolar disorder, or a history of schizophrenia. 6. History of alcohol or substance abuse or dependence within the past two years. 7. History of malignancy within the past 3 years. 8. Clinically significant abnormalities in screening laboratories (defined as greater than mild on the FDA's vaccine toxicity grading scale). 9. Participation in another clinical trial of an investigational drug concurrently or within the past 30 days. 10. Low affinity TSPO binders (for PET ligand \[18F\]PBR06) determined by having a Thr/Thr polymorphism in the TSPO gene at screening. 11. Sensitivity to florbetapir F18. 12. Active COVID-19 disease. 13. Amyloid-negative PET scan. 14. COVID-19 vaccine within the past ten days or any other vaccine within the past seven days (at dosing)

Study sites (1)

MA