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Brexpiprazole for the Treatment of Agitation in Alzheimer Dementia: A Randomized Clinical Trial
Lee D, Slomkowski M, Hefting N, Chen D, Larsen KG, Kohegyi E, Hobart M, Cummings JL et al.. JAMA neurology, 2023-12-01
Topic: Amyloid, tau and blood-test diagnosis
Results A total of 345 patients were randomized to receive brexpiprazole (n = 228) or placebo (n = 117); completion rates were 198 (86.8%) for brexpiprazole and 104 (88.9%) for placebo. Patients receiving brexpiprazole, 2 or 3 mg (n = 225), demonstrated statistically significantly greater improvement than those taking placebo (n = 116) in Cohen-Mansfield Agitation Inventory total score from baseline to week 12 (brexpiprazole baseline, 80.6, mean change, -22.6; placebo baseline, 79.2, mean change, -17.3; least-squares mean difference, -5.32; 95% CI, -8.77 to -1.87; P = .003; Cohen d effect size, 0.35). Conclusions and relevance In this study, patients with Alzheimer dementia who took brexpiprazole, 2 or 3 mg, showed a statistically significant improvement vs placebo in agitation over 12 weeks.
Key findings
- Results A total of 345 patients were randomized to receive brexpiprazole (n = 228) or placebo (n = 117); completion rates were 198 (86.8%) for brexpiprazole and 104 (88.9%) for placebo.
- Patients receiving brexpiprazole, 2 or 3 mg (n = 225), demonstrated statistically significantly greater improvement than those taking placebo (n = 116) in Cohen-Mansfield Agitation Inventory total score from baseline to week 12 (brexpiprazole baseline, 80.6, mean change, -22.6; placebo baseline, 79.2, mean change, -17.3; least-squares mean difference, -5.32; 95% CI, -8.77 to -1.87; P = .003; Cohen d effect size, 0.35).
- Conclusions and relevance In this study, patients with Alzheimer dementia who took brexpiprazole, 2 or 3 mg, showed a statistically significant improvement vs placebo in agitation over 12 weeks.
Why it matters
In this trial of 345 patients, those taking brexpiprazole 2 or 3 mg showed statistically significantly greater improvement in agitation than those taking placebo over 12 weeks. This addresses a behavioral symptom of Alzheimer dementia, not the underlying disease, and the trial did not test whether the drug changes the course of the illness.
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Study details
- Participants228
- Effect size86.8%; 88.9%; 56.5%
- Evidence strengthHigh
How this study scored 65/100
Published in a leading specialty journal. Scored zero for study design because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (JAMA neurology) |
| Journal's citation record | 2 / 4 | JAMA Neurology: journal h-index 235 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (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 | 3 / 5 | 2023 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 228 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 5 / 7 | Cited 130 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 26.0 citations a year over 5 year(s) since 2023 |
| Impact for its field and year | 5 / 6 | Cited 23.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 6 other studies in this library |
| Still being cited | 3 / 4 | Cited 129 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author George Thomas Grossberg: h-index 58 (OpenAlex, whole career) |
| Institution's track record | 0 / 3 | Saint Louis University: institution h-index 567 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 5 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 37930669) |
| Free to read | 2 / 2 | Free to read |
| Total | 65 / 100 | — |
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Read the original
- DOI: 10.1001/jamaneurol.2023.3810
- PubMed: 37930669
- Original source →
- Free full text: JAMA Neurology →
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
Lee, D., Slomkowski, M., Hefting, N., Chen, D., Larsen, K. G., Kohegyi, E., et al. (2023). Brexpiprazole for the Treatment of Agitation in Alzheimer Dementia: A Randomized Clinical Trial. JAMA neurology. https://doi.org/10.1001/jamaneurol.2023.3810
Vancouver
Lee D, Slomkowski M, Hefting N, Chen D, Larsen KG, Kohegyi E, et al. Brexpiprazole for the Treatment of Agitation in Alzheimer Dementia: A Randomized Clinical Trial. JAMA neurology. 2023. doi:10.1001/jamaneurol.2023.3810. PMID: 37930669.
BibTeX
@article{lee2023-37930669,
author = {Lee, D. and Slomkowski, M. and Hefting, N. and Chen, D. and Larsen, K. G. and Kohegyi, E. and Hobart, M. and Cummings, J. L. and others},
title = {{Brexpiprazole for the Treatment of Agitation in Alzheimer Dementia: A Randomized Clinical Trial}},
journal = {JAMA neurology},
year = {2023},
doi = {10.1001/jamaneurol.2023.3810},
pmid = {37930669},
url = {https://doi.org/10.1001/jamaneurol.2023.3810}
}
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