Foralumab for Alzheimer's Disease and Mild Cognitive Impairment
This study is testing a nasal spray called Foralumab (TZLS-401) for people with Alzheimer's disease or mild cognitive impairment due to Alzheimer's. Foralumab is an antibody, a type of protein made by the immune system. Previous research suggests Foralumab might help reduce brain inflammation by affecting immune cells called microglia. This study will look at how safe Foralumab is at two different doses (50 µg and 100 µg) compared to a placebo (an inactive spray). Researchers will also use PET scans to see how Foralumab affects microglial function and will check certain immune cell markers in your blood. You may be able to join if you are between 60 and 85 years old and meet specific diagnostic criteria for Alzheimer's disease, including certain memory test scores. The study plans to enroll 16 participants.
- Study design
- This is a randomized, double-blind, placebo-controlled study with 16 participants. Participants will be randomly assigned to receive either Foralumab or a placebo.
- What's involved
- You would receive the nasal spray three times a week for two weeks, followed by a one-week break, for a total of three months (four cycles). You will have assessments, including PET scans and blood tests, from the beginning of the study up to 20 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor you for adverse events from the start of the study up to 20 weeks. Blood biomarkers will be measured up to 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- The number of adverse events in drug versus placebo groups.From baseline to the end of study, up to 20 weeks.
Establish the safety and tolerability of nasal foralumab dosing in subjects as a percentage of drug and placebo groups who experience adverse events.
- Assessment of microglial function via PET scan using the ligand [18F]PBR06From baseline to end of study, up to 20 weeks.
The ligand \[18F\]PBR06 provides a quantification of microglial activation during a PET scan. The investigatorshope to use this tracer at the start and end of the study to examine how the use of Foralumab may affect microglial function.
- Measure the effect of foralumab on the ratio of CD4/CD8 memory/naïve T cells biomarkers in bloodFrom baseline to the end of treatment, up to 12 weeks.