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A randomized clinical trial of low-dose cannabis extract in Alzheimer's disease
Rafael de Morais Cury, Taynara da Silva, Fernando Cezar-Dos-Santos, Yasmin Rafaela Correia Fakih, Karlin Andrea Ramírez Narvaez, Murilo Chaves Gouvea, Carlos Espínola, Charles Francisco Ferreira et al.. Journal of Alzheimer's disease : JAD, 2025-10-29
Topic: Drug trials: efficacy and safety
Plain-language summary
BackgroundPreclinical and clinical evidence suggest that low-dose cannabinoids could ameliorate Alzheimer's disease (AD) signs and symptoms. We designed this trial to evaluate the safety and efficacy of low-dose THC-CBD balanced cannabinoid extract in the treatment of patients with AD-associated dementia.ObjectiveThe objective of this phase 2 trial was to evaluate the safety and efficacy of a balanced THC-CBD cannabinoid extract for symptomatic patients with AD.MethodsA Phase 2, randomized, double-blind, placebo-controlled, clinical trial including patients between 60 and 80 years-old diagnosed with AD-associated dementia. For 26 weeks, participants orally received either placebo or THC-CBD extract (0.350 mg/THC and 0.245 mg/CBD), daily.ResultsAt week 26, Mini-Mental State Exam total score was significantly higher in cannabis- when compared to placebo-treated patients, which was assessed using the mixed model analysis. No significant difference was detected between placebo and cannabis groups in terms of secondary outcomes and adverse events incidence.ConclusionsTo this date, this is the longest clinical trial evaluating cannabinoids effects on AD patients. We initially demonstrate that low-dose THC-CBD potentially can be an effective and safe therapeutic option for AD-related dementia. Nonetheless, larger and longer trials are necessary to confirm this finding and establish cannabinoid administration as therapy for AD dementia.Trial RegistrationThe Brazilian Registry of Clinical Trials (ReBEC) registration #U1111-1258-2058 - REBEC (ensaiosclinicos.gov.br).
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APA 7th
Cury, R. d. M., da Silva, T., Cezar-Dos-Santos, F., Fakih, Y. R. C., Narvaez, K. A. R., Gouvea, M. C., et al. (2025). A randomized clinical trial of low-dose cannabis extract in Alzheimer's disease. Journal of Alzheimer's disease : JAD. https://doi.org/10.1177/13872877251389608
Vancouver
Cury RdM, da Silva T, Cezar-Dos-Santos F, Fakih YRC, Narvaez KAR, Gouvea MC, et al. A randomized clinical trial of low-dose cannabis extract in Alzheimer's disease. Journal of Alzheimer's disease : JAD. 2025. doi:10.1177/13872877251389608. PMID: 41160460.
BibTeX
@article{cury2025-41160460,
author = {Cury, Rafael de Morais and da Silva, Taynara and Cezar-Dos-Santos, Fernando and Fakih, Yasmin Rafaela Correia and Narvaez, Karlin Andrea Ramírez and Gouvea, Murilo Chaves and Espínola, Carlos and Ferreira, Charles Francisco and others},
title = {{A randomized clinical trial of low-dose cannabis extract in Alzheimer's disease}},
journal = {Journal of Alzheimer's disease : JAD},
year = {2025},
doi = {10.1177/13872877251389608},
pmid = {41160460},
url = {https://doi.org/10.1177/13872877251389608}
}
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Key findings
- BackgroundPreclinical and clinical evidence suggest that low-dose cannabinoids could ameliorate Alzheimer's disease (AD) signs and symptoms.
- For 26 weeks, participants orally received either placebo or THC-CBD extract (0.350 mg/THC and 0.245 mg/CBD), daily.ResultsAt week 26, Mini-Mental State Exam total score was significantly higher in cannabis- when compared to placebo-treated patients, which was assessed using the mixed model analysis.
- No significant difference was detected between placebo and cannabis groups in terms of secondary outcomes and adverse events incidence.ConclusionsTo this date, this is the longest clinical trial evaluating cannabinoids effects on AD patients.
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Study details
- Study designclinical trial
- Evidence strengthHigh
How this study scored 79/100
Published in a peer-reviewed journal, and it is a randomized controlled trial. Scored zero for sample size and effect reported because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multicenter collaboration and free to read, so those were left out: it earned 44 of the 56 points we could judge it on, which is 79 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of Alzheimer's disease : JAD) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| 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 | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| 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 (pubmed indexes it as a clinical or observational study) |
| Randomized / blinded | 2 / 2 | Randomized and blinded or placebo-controlled (as stated in the record) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41160460) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 44 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 44 of the 56 points we could judge it on is 79 out of 100. |
| Total | 79 / 100 | — |
What each of these 20 components measures, and what this score is not →
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