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A Randomized Controlled Trial of the Safety and Efficacy of Dronabinol for Agitation in Alzheimer's Disease
Rosenberg PB, Amjad H, Burhanullah H, Nowrangi M, Vandrey R, Pierre MJ, Outen JD, Schultz M, Marano C, Agronin M, et al.. The American Journal of Geriatric Psychiatry, 2025-11-10
Topic: Risk, prevention and care in population studies
Plain-language summary
Results The majority of participants were female and were taking concomitant psychotropic medications (antidepressants and antipsychotics) at baseline. The fitted between-arm difference in PAS decline/week was -0.74 (SE 0.3, p = 0.015, effect size = 0.53) and for NPI-C A/A the decline was not significant at -1.26 (SE 0.67, p = 0.094, effect size = 0.36). Dronabinol treatment was not associated with greater intoxication nor with other adverse events (AEs) except for somnolence.
What this study adds
Evidence grade: Early
The record lists 75 participants. In this phase 2 trial, dronabinol was associated with a significant decline in agitation scores on one measure, but the decline on another measure was not significant. Reported effect size: PAS decline difference -0.74/week (p=0.015, ES 0.53); NPI-C A/A -1.26/week (p=0.094, ES 0.36).
Taken from this record’s own fields, not from reading the paper. The grade is assigned from the abstract’s wording; what that means.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Rosenberg, P. B., Amjad, H., Burhanullah, H., Nowrangi, M., Vandrey, R., Pierre, M. J., et al. (2025). A Randomized Controlled Trial of the Safety and Efficacy of Dronabinol for Agitation in Alzheimer's Disease. The American Journal of Geriatric Psychiatry. https://doi.org/10.1016/j.jagp.2025.10.011
Vancouver
Rosenberg PB, Amjad H, Burhanullah H, Nowrangi M, Vandrey R, Pierre MJ, et al. A Randomized Controlled Trial of the Safety and Efficacy of Dronabinol for Agitation in Alzheimer's Disease. The American Journal of Geriatric Psychiatry. 2025. doi:10.1016/j.jagp.2025.10.011. PMID: 41350162.
BibTeX
@article{rosenberg2025-41350162,
author = {Rosenberg, P. B. and Amjad, H. and Burhanullah, H. and Nowrangi, M. and Vandrey, R. and Pierre, M. J. and Outen, J. D. and Schultz, M. and Marano, C. and Agronin, M. and others},
title = {{A Randomized Controlled Trial of the Safety and Efficacy of Dronabinol for Agitation in Alzheimer's Disease}},
journal = {The American Journal of Geriatric Psychiatry},
year = {2025},
doi = {10.1016/j.jagp.2025.10.011},
pmid = {41350162},
url = {https://doi.org/10.1016/j.jagp.2025.10.011}
}
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.
Key findings
- Results The majority of participants were female and were taking concomitant psychotropic medications (antidepressants and antipsychotics) at baseline.
- The fitted between-arm difference in PAS decline/week was -0.74 (SE 0.3, p = 0.015, effect size = 0.53) and for NPI-C A/A the decline was not significant at -1.26 (SE 0.67, p = 0.094, effect size = 0.36).
- Dronabinol treatment was not associated with greater intoxication nor with other adverse events (AEs) except for somnolence.
Why it matters
In this phase 2 trial, dronabinol was associated with a significant decline in agitation scores on one measure, but the decline on another measure was not significant. Dronabinol was not associated with greater intoxication or other adverse events except somnolence.
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Study details
- Study designphase-2-trial
- Participants75
- Effect sizePAS decline difference -0.74/week (p=0.015, ES 0.53); NPI-C A/A -1.26/week (p=0.094, ES 0.36)
- Evidence strengthEarly
Limitations
Small (n=75) and short (3 weeks); one of two co-primary outcomes was not significant; most participants were on concurrent psychotropics; long-term safety unknown.
How this study scored 60/100
Published in a peer-reviewed journal, and it is a mid-stage phase 2 trial. We have no data on free to read, so that was left out: it earned 59 of the 98 points we could judge it on, which is 60 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The American Journal of Geriatric Psychiatry) |
| Journal's citation record | 2 / 4 | American Journal of Geriatric Psychiatry: journal h-index 178 (OpenAlex, 2026-10-29) |
| Study design | 8 / 12 | A mid-stage phase 2 trial |
| Strength of evidence | 2 / 5 | Rated “early” 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 | 75 participants |
| Effect reported | 3 / 3 | Effect reported with a statistic (interval, p-value, ratio or similar) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomized / blinded | 1 / 2 | Randomized (as stated in the record) |
| Times cited | 2 / 7 | Cited 10 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 3.3 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 3 / 6 | Cited 4.9× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 1 / 4 | Cited 10 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Brent P. Forester: h-index 42 (OpenAlex, whole career) |
| Institution's track record | 3 / 3 | Harvard University: institution h-index 3,235 (OpenAlex) |
| Multicenter collaboration | 3 / 3 | OpenAlex lists 12 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41350162) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 59 / 98 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 59 of the 98 points we could judge it on is 60 out of 100. |
| Total | 60 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1016/j.jagp.2025.10.011
- PubMed: 41350162
- Original source →
- Free full text: pmc.ncbi.nlm.nih.gov →
Full text: free to read — Unpaywall lists this copy as free to read: the link above (checked 10 Oct 2026).
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