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Safety, Cognitive, and Behavioral Outcomes in Patients with Dementia with Lewy Bodies Treated with Nilotinib
Fernando Pagán, Yasar A. Torres-Yaghi, Michaeline L. Hebron, Barbara Wilmarth, Raymond Scott Turner, Sara Matar, Xiaoguang Liu, Dalila Ferrante et al.. Journal of Clinical Medicine, 2025-06-14
Topic: Risk, prevention and care in population studies
Of 43 individuals enrolled, 14 were women (33%); age (mean ± SD) was 73 ± 8.5 years. Nilotinib was safe and well-tolerated, and more adverse events were noted in the placebo (74) vs. nilotinib (37) groups (p = 0.054). The number of falls were reduced in the nilotinib (six) compared to placebo (21) group (p = 0.006). Cerebrospinal fluid homovanillic acid, a biomarker of dopamine levels, was increased (p = 0.004), while the ratio of pTau181/Aβ42 was reduced (p = 0.034). The Alzheimer’s Disease Assessment Scale—cognition 14 improved by 2.8 pts (p = 0.037), and no differences were observed in Movement Disorders Society–Unified Parkinson’s Disease Rating Scale parts II and III. However, part I (cognition) improved (p = 0.044) in nilotinib compared to placebo. Nilotinib demonstrates favorable safety, biomarkers, and efficacy outcomes in patients with DLB supporting further trials in DLB or advanced Parkinson’s disease with dementia.
Key findings
- Of 43 individuals enrolled, 14 were women (33%); age (mean ± SD) was 73 ± 8.5 years.
- Nilotinib was safe and well-tolerated, and more adverse events were noted in the placebo (74) vs. nilotinib (37) groups (p = 0.054).
- The number of falls were reduced in the nilotinib (six) compared to placebo (21) group (p = 0.006).
- Cerebrospinal fluid homovanillic acid, a biomarker of dopamine levels, was increased (p = 0.004), while the ratio of pTau181/Aβ42 was reduced (p = 0.034).
- The Alzheimer’s Disease Assessment Scale—cognition 14 improved by 2.8 pts (p = 0.037), and no differences were observed in Movement Disorders Society–Unified Parkinson’s Disease Rating Scale parts II and III.
Why it matters
In this clinical trial of 43 people with dementia with Lewy bodies, nilotinib was safe and well tolerated, with fewer falls, increased cerebrospinal fluid homovanillic acid, a reduced pTau181/Aβ42 ratio, and improved cognition scores compared with placebo. The authors state these results support further trials in dementia with Lewy bodies or advanced Parkinson's disease with dementia, so this is an early trial in a different disease, not a proven treatment for Alzheimer's disease.
Study details
- Study designclinical trial
- Participants43
- Evidence strengthHigh
How this study scored 48/100
Published in a peer-reviewed journal. Scored zero for study design, effect reported and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of Clinical Medicine) |
| Journal's citation record | 2 / 4 | Journal of Clinical Medicine: journal h-index 188 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 1 / 4 | 43 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 2 / 7 | Cited 7 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 2.3 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 3 / 6 | Cited 3.9× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 1 / 6 | Cited by 1 other studies in this library |
| Still being cited | 1 / 4 | Cited 7 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Charbel Moussa: h-index 42 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Georgetown University: institution h-index 824 (OpenAlex) |
| Multi-centre collaboration | 1 / 3 | OpenAlex lists 3 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40565990) |
| Free to read | 2 / 2 | Free to read |
| Total | 48 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.3390/jcm14124245
- PubMed: 40565990
- Original source →
- Free full text: Journal of Clinical Medicine →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Pagán, F., Torres-Yaghi, Y. A., Hebron, M. L., Wilmarth, B., Turner, R. S., Matar, S., et al. (2025). Safety, Cognitive, and Behavioral Outcomes in Patients with Dementia with Lewy Bodies Treated with Nilotinib. Journal of Clinical Medicine. https://doi.org/10.3390/jcm14124245
Vancouver
Pagán F, Torres-Yaghi YA, Hebron ML, Wilmarth B, Turner RS, Matar S, et al. Safety, Cognitive, and Behavioral Outcomes in Patients with Dementia with Lewy Bodies Treated with Nilotinib. Journal of Clinical Medicine. 2025. doi:10.3390/jcm14124245. PMID: 40565990.
BibTeX
@article{pagan2025-40565990,
author = {Pagán, Fernando and Torres-Yaghi, Yasar A. and Hebron, Michaeline L. and Wilmarth, Barbara and Turner, Raymond Scott and Matar, Sara and Liu, Xiaoguang and Ferrante, Dalila and others},
title = {{Safety, Cognitive, and Behavioral Outcomes in Patients with Dementia with Lewy Bodies Treated with Nilotinib}},
journal = {Journal of Clinical Medicine},
year = {2025},
doi = {10.3390/jcm14124245},
pmid = {40565990},
url = {https://doi.org/10.3390/jcm14124245}
}
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