Proof of Concept Study on Clinical Trial Outcomes and Biomarkers in Early Lewy Body Dementia
Official title: Proof of Concept (Phase 0) Study of Clinical Trial Outcomes and Biomarkers in Early Stage Dementia with Lewy Bodies
Funded at University of Miami School of Medicine · NIH-11341276 · Data updated 2026-11-12
A small, early-stage study is testing whether new biomarkers and trial outcomes can better measure symptoms and treatment effects for people with Lewy body dementia.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Miami School of Medicine NIH-funded |
| Lab location | 1 site (Coral Gables, United States) |
| Project start | September 20, 2026 |
| Project end | May 31, 2031 |
| Funding year | 2026 |
| Award (this year) | $644,011 |
| NIH project number | 1R01AG100419-01 |
| Project ID | NIH-11341276 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults diagnosed with Lewy body dementia or Parkinson’s disease with dementia, especially in early stages, who can participate in biomarker testing and outcome measurements.
✕Less likely to help
Individuals without Lewy body dementia or those unable to participate in biomarker assessments or follow-up visits may not benefit.
What this research studies
This project focuses on people with early Lewy body dementia, including DLB and PD with dementia. It aims to identify reliable biomarkers and suitable clinical trial outcomes that reflect how the disease progresses and responds to potential therapies. The study will explore phase 0 approaches to gauge whether proposed outcomes and biomarkers are informative before larger trials. Researchers will work with patients and caregivers to understand daily living impacts and how biomarkers relate to everyday function. Findings could guide future, larger trials and improve target engagement in this disease.
Why it matters
Potential benefit: If successful, the research could lead to better ways to diagnose Lewy body dementia earlier and measure whether treatments help patients in meaningful ways.
How similar studies have gone: Previous work in related dementias has shown that biomarkers and trial outcomes can be challenging to translate, but targeted phase 0 approaches offer promise for clarifying useful measures.
Where this research is happening
-
University of Miami School of Medicine
Coral Gables, United States Active
Researchers
- Principal investigator: Galvin, James E — University of Miami School of Medicine
- Study coordinator: Galvin, James E
Related research
Other NIH-funded projects on the same topics.
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Understanding how heparan sulfate affects alpha-synuclein in Lewy body dementia
A small study in people who have dementia with Lewy bodies looks at how a brain sugar (heparan sulfate) helps a harmful protein (alpha-synuclein) spread, with the hope of slowing disease progression.
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Alpha-synuclein seed test in blood or urine for Parkinson’s and Lewy body diseases
A new blood or urine test using seed amplification to help diagnose Parkinson’s disease, dementia with Lewy bodies, and related conditions earlier and more clearly.
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Dementia with Lewy Bodies Consortium
A national research effort to better understand and diagnose Lewy body dementia by studying biomarkers and patient data over time.
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Rat model of dementia with Lewy bodies may help us study memory and movement problems
A scientist team is creating and validating a rat model that mirrors Dementia with Lewy Bodies to better understand how it develops and to test potential treatments.
-
Amyloid-clearing therapy for dementia with Lewy bodies plus Alzheimer's disease
A study tests an amyloid-clearing antibody in people who have both Dementia with Lewy bodies and Alzheimer's disease to see if it can safely help with their symptoms.
-
New method to deliver treatments for dementia with Lewy bodies
This study is exploring a new way to deliver special treatments that can help reduce harmful proteins linked to dementia, using a friendly peptide to help get these treatments into the brain more easily, with the goal of making therapies safer and more effective for people with dementia.
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.