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NCT06489548 · ClinicalTrials.gov registry record · Phase 2
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
A Phase 2 study of Dementia and Alzheimers Disease, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06489548: Recruiting Phase 2 study of Dementia and Alzheimers Disease, sponsored by Brigham and Women's Hospital.
NCT06489548 is a Phase 2 study of Dementia and Alzheimers Disease that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06489548, a Phase 2 study of Dementia and Alzheimers Disease, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
Establish the safety and tolerability of nasal foralumab dosing in subjects as a percentage of drug and placebo groups who experience adverse events.
Conditions Studied
Interventions
- DRUG Foralumab TZLS-401 50 µg
- DRUG Foralumab TZLS-401 100 µg
Study Locations (1)
Massachusetts
- Center for Alzheimer Research and Treatment, Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-09-16 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT06489548 shows while recruiting
NCT06489548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Dementia appearing as the primary indexed condition, and to 2 interventions - of which Foralumab TZLS-401 50 µg is the first listed.
NCT06489548 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06489548 about?
NCT06489548 is a clinical study titled "Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease". 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 i...
What is the current status of trial NCT06489548?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2025-09-16. Estimated completion is 2026-12.
What conditions does trial NCT06489548 study?
This clinical trial studies the following conditions: Dementia, Alzheimers Disease, Mild Cognitive Impairment Due to Alzheimer's Disease.
What interventions are being tested in trial NCT06489548?
The interventions under investigation include: Foralumab TZLS-401 50 µg (DRUG), Foralumab TZLS-401 100 µg (DRUG).
Who is sponsoring clinical trial NCT06489548?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06489548 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dementia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06489548's enrollment target sits among peer trials
16 192nd of 199 higher than 8 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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