IND enabling safety studies and early human testing for PV-1950R vaccine in Lewy Body Dementia
Official title: IND enabling CMC/safety/toxicology studies, submission of IND and pilot Phase 1 clinical trial with PV-1950R vaccine for Lewy Body Dementia (LBD)
Funded at Institute for Molecular Medicine · NIH-11378326 · Data updated 2026-11-12
A study to prepare and test a PV-1950R vaccine aimed at Lewy Body Dementia to potentially slow or prevent disease progression.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Institute for Molecular Medicine NIH-funded |
| Lab location | 1 site (Huntington Beach, United States) |
| Project start | June 5, 2024 |
| Project end | May 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $1,759,263 |
| NIH project number | 5U01AG084528-03 |
| Project ID | NIH-11378326 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults diagnosed with Lewy Body Dementia or related conditions who are eligible for early-phase vaccine trials and meet safety criteria.
✕Less likely to help
Some participants may not experience any clinical benefit and may face typical vaccine trial risks.
What this research studies
This project focuses on preparing an IND submission and conducting initial safety checks for PV-1950R as a candidate treatment for Lewy Body Dementia. The work includes chemistry, manufacturing, and safety/toxicity analyses, followed by a pilot Phase 1 clinical trial to explore how the vaccine behaves in people. The team will engage with regulators and design a first-in-human trial, with patient safety as the top priority. By targeting alpha-synuclein pathology, the study hopes to open a path to new treatment options for patients and families affected by LBD.
Why it matters
Potential benefit: If successful, the vaccine could lead to new treatment options that may slow disease progression and reduce caregiver burden for people with Lewy Body Dementia.
How similar studies have gone: Immunotherapy approaches targeting alpha-synuclein have shown promise in preclinical work and early trials in related disorders, but this exact vaccine has not yet been proven effective in LBD.
Where this research is happening
-
Institute for Molecular Medicine
Huntington Beach, United States Active
Researchers
- Principal investigator: Agadjanyan, Michael G — Institute for Molecular Medicine
- Study coordinator: Agadjanyan, Michael G
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.