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Association of Plasma Phosphorylated Tau With the Response to Neflamapimod Treatment in Patients With Dementia With Lewy Bodies
Alam JJ, Maruff P, Doctrow SR, Chu HM, Conway J, Gomperts SN, Teunissen C.. Neurology, 2023-09-01
Topic: Brain proteins, microglia and lab models
Background and objectives In a proportion of patients, dementia with Lewy bodies (DLB) is associated with Alzheimer disease (AD) copathology, which is linked to accelerated cognitive decline and more extensive cortical atrophy. Methods The AscenD-LB study was a phase 2a, randomized (1:1), 16-week, placebo-controlled clinical trial of neflamapimod in DLB, the main results of which have been published. Clinical outcomes for the comparison of placebo with neflamapimod 40 mg three times daily (TID; the higher and more clinically active of 2 doses studied) were analyzed using mixed models for repeated measures within each subgroup (baseline plasma ptau181 Results Pretreatment plasma ptau181 levels were determined in eighty-five participants with mild-to-moderate DLB receiving cholinesterase inhibitors, with 45 participants below and 40 above the 2.2 pg/mL cutoff at baseline. In the 16-week treatment period, in the comparison of placebo with neflamapimod 40 mg TID, for all end points evaluated, improvements with neflamapimod treatment were greater in participants below the cutoff, compared with those above the cutoff. In addition, participants below the ptau181 cutoff at baseline showed significant improvement over placebo in an attention composite measure (+0.42, 95% CI 0.07-0.78, p = 0.023, d = 0.78), the Clinical Dementia Rating Scale Sum of Boxes (-0.60, 95% CI -1.04 to -0.06, p = 0.031, d = 0.70), the Timed Up and Go test (-3.1 seconds, 95% CI -4.7 to -1.6, p d = 0.74), and International Shopping List Test-Recognition (+1.4, 95% CI 0.2-2.5, p = 0.024, d = 1.00).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Alam, J. J., Maruff, P., Doctrow, SR., Chu, H. M., Conway, J., Gomperts, S. N., et al. (2023). Association of Plasma Phosphorylated Tau With the Response to Neflamapimod Treatment in Patients With Dementia With Lewy Bodies. Neurology. https://doi.org/10.1212/wnl.0000000000207755
Vancouver
Alam JJ, Maruff P, Doctrow SR, Chu HM, Conway J, Gomperts SN, et al. Association of Plasma Phosphorylated Tau With the Response to Neflamapimod Treatment in Patients With Dementia With Lewy Bodies. Neurology. 2023. doi:10.1212/wnl.0000000000207755. PMID: 37657939.
BibTeX
@article{alam2023-37657939,
author = {Alam, J. J. and Maruff, P. and Doctrow, SR. and Chu, H. M. and Conway, J. and Gomperts, S. N. and Teunissen, C.},
title = {{Association of Plasma Phosphorylated Tau With the Response to Neflamapimod Treatment in Patients With Dementia With Lewy Bodies}},
journal = {Neurology},
year = {2023},
doi = {10.1212/wnl.0000000000207755},
pmid = {37657939},
url = {https://doi.org/10.1212/wnl.0000000000207755}
}
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 names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
Key findings
- Background and objectives In a proportion of patients, dementia with Lewy bodies (DLB) is associated with Alzheimer disease (AD) copathology, which is linked to accelerated cognitive decline and more extensive cortical atrophy.
- Methods The AscenD-LB study was a phase 2a, randomized (1:1), 16-week, placebo-controlled clinical trial of neflamapimod in DLB, the main results of which have been published.
- Clinical outcomes for the comparison of placebo with neflamapimod 40 mg three times daily (TID; the higher and more clinically active of 2 doses studied) were analyzed using mixed models for repeated measures within each subgroup (baseline plasma ptau181 < and ≥2.2 pg/mL).
- In the 16-week treatment period, in the comparison of placebo with neflamapimod 40 mg TID, for all end points evaluated, improvements with neflamapimod treatment were greater in participants below the cutoff, compared with those above the cutoff.
- In addition, participants below the ptau181 cutoff at baseline showed significant improvement over placebo in an attention composite measure (+0.42, 95% CI 0.07-0.78, p = 0.023, d = 0.78), the Clinical Dementia Rating Scale Sum of Boxes (-0.60, 95% CI -1.04 to -0.06, p = 0.031, d = 0.70), the Timed Up and Go test (-3.1 seconds, 95% CI -4.7 to -1.6, p < 0.001, d = 0.74), and International Shopping List Test-Recognition (+1.4, 95% CI 0.2-2.5, p = 0.024, d = 1.00).
Why it matters
In this trial of neflamapimod in people with dementia with Lewy bodies, improvements were greater in participants with lower baseline plasma phosphorylated tau, with significant improvement over placebo on some measures in that group. It is about a subgroup response in dementia with Lewy bodies, not about treating, curing or preventing Alzheimer disease.
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Study details
- Participants45
- Evidence strengthHigh
How this study scored 71/100
Published in a leading specialty journal, and it is a randomized controlled trial. Scored zero for effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | 4 / 4 | Neurology: journal h-index 525 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomized controlled trial (from PubMed type “Randomized Controlled Trial”) |
| 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 | 3 / 5 | 2023 — within 6 year(s) of the newest study here |
| Sample size | 1 / 4 | 45 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 | 2 / 2 | Randomized and blinded or placebo-controlled (as stated in the record) |
| Times cited | 3 / 7 | Cited 25 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 5.0 citations a year over 5 year(s) since 2023 |
| 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 2 other studies in this library |
| Still being cited | 2 / 4 | Cited 24 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 4 / 4 | Last-listed author Charlotte Elisabeth Teunissen: h-index 116 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Massachusetts General Hospital: institution h-index 2,057 (OpenAlex) |
| Multicenter collaboration | 2 / 3 | OpenAlex lists 5 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 37657939) |
| Free to read | 2 / 2 | Free to read |
| Total | 71 / 100 | — |
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