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A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias
Haroon J, Jordan K, Mahdavi K, Rindner E, Becerra S, Surya JR, Zielinski M, Venkatraman V et al.. Medicine, 2024-07-01
Topic: Amyloid, tau and blood-test diagnosis
Background Alzheimer's disease (AD) is a progressive, multifactorial, neurodegenerative disorder affecting >6 million Americans. Chronic, low-grade neuroinflammation, and insulin resistance may drive AD pathogenesis. We explored the neurophysiological and neuropsychological effects of NE3107, an oral, anti-inflammatory, insulin-sensitizing molecule, in AD. Methods In this phase 2, open-label study, 23 patients with mild cognitive impairment or mild dementia received 20-mg oral NE3107 twice daily for 3 months. Primary endpoints assessed changes from baseline in neurophysiological health and oxidative stress (glutathione level) using advanced neuroimaging analyses. Secondary endpoints evaluated changes from baseline in neuropsychological health using cognitive assessments, including the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment, Clinical Dementia Rating, Quick Dementia Rating Scale, Alzheimer's Disease Composite Score, and Global Rating of Change (GRC). Exploratory endpoints assessed changes from baseline in neuroinflammation biomarkers (tumor necrosis factor alpha, TNF-α) and AD (amyloid beta and phosphorylated tau [P-tau]). Results NE3107 was associated with clinician-rated improvements in cerebral blood flow and functional connectivity within the brain. In patients with MMSE ≥ 20 (mild cognitive impairment to mild AD; n = 17), NE3107 was associated with directional, but statistically nonsignificant, changes in brain glutathione levels, along with statistically significant improvements in ADAS-Cog11 (P = .017), Clinical Dementia Rating (P = .042), Quick Dementia Rating Scale (P = .002), Alzheimer's Disease Composite Score (P = .0094), and clinician-rated GRC (P Conclusion Our results indicate that in this study NE3107 was associated with what appear to be positive neurophysiological and neuropsychological findings, as well as evidence of improvement in biomarkers associated with neuroinflammation and AD in patients diagnosed with dementia. Our findings are consistent with previous preclinical and clinical observations and highlight a central role of neuroinflammation in AD pathogenesis.
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APA 7th
Haroon, J., Jordan, K., Mahdavi, K., Rindner, E., Becerra, S., Surya, JR., et al. (2024). A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias. Medicine. https://doi.org/10.1097/md.0000000000039027
Vancouver
Haroon J, Jordan K, Mahdavi K, Rindner E, Becerra S, Surya JR, et al. A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias. Medicine. 2024. doi:10.1097/md.0000000000039027. PMID: 39058809.
BibTeX
@article{haroon2024-39058809,
author = {Haroon, J. and Jordan, K. and Mahdavi, K. and Rindner, E. and Becerra, S. and Surya, JR. and Zielinski, M. and Venkatraman, V. and others},
title = {{A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias}},
journal = {Medicine},
year = {2024},
doi = {10.1097/md.0000000000039027},
pmid = {39058809},
url = {https://doi.org/10.1097/md.0000000000039027}
}
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Key findings
- Results NE3107 was associated with clinician-rated improvements in cerebral blood flow and functional connectivity within the brain.
- In patients with MMSE ≥ 20 (mild cognitive impairment to mild AD; n = 17), NE3107 was associated with directional, but statistically nonsignificant, changes in brain glutathione levels, along with statistically significant improvements in ADAS-Cog11 (P = .017), Clinical Dementia Rating (P = .042), Quick Dementia Rating Scale (P = .002), Alzheimer's Disease Composite Score (P = .0094), and clinician-rated GRC (P < .001), as well as in cerebrospinal fluid P-tau levels (P = .034) and P-tau:amyloid beta 42 ratio (P = .04).
- Our findings are consistent with previous preclinical and clinical observations and highlight a central role of neuroinflammation in AD pathogenesis.
Why it matters
In a phase 2, open-label study, 23 people with mild cognitive impairment or mild dementia took NE3107, an oral anti-inflammatory drug, twice daily for 3 months. It was associated with clinician-rated improvements in brain blood flow and, in the 17 patients with milder disease, statistically significant gains on several cognitive and dementia rating scales. Because the study was open-label, meaning everyone knew they were getting the drug, these are early signals rather than proof that it works.
Study details
- Study designclinical trial
- Participants17
- Evidence strengthLow
How this study scored 56/100
Published in a peer-reviewed journal, and it is a mid-stage phase 2 trial. Scored zero for effect reported and randomized / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Medicine) |
| Journal's citation record | 3 / 4 | Medicine: journal h-index 285 (OpenAlex, 2026-10-29) |
| Study design | 8 / 12 | A mid-stage phase 2 trial (from PubMed type “Clinical Trial, Phase II”) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2024 — within 3 year(s) of the newest study here |
| Sample size | 1 / 4 | 17 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) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 3 / 7 | Cited 19 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 4.8 citations a year over 4 year(s) since 2024 |
| Impact for its field and year | 3 / 6 | Cited 4.5× 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 | 2 / 4 | Cited 19 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 1 / 4 | Last-listed author Sheldon Jordan: h-index 10 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | University of California, Los Angeles: institution h-index 1,923 (OpenAlex) |
| Multicenter collaboration | 1 / 3 | OpenAlex lists 2 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 39058809) |
| Free to read | 2 / 2 | Free to read |
| Total | 56 / 100 | — |
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