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Safety and efficacy of losartan for the reduction of brain atrophy in clinically diagnosed Alzheimer's disease (the RADAR trial): a double-blind, randomised, placebo-controlled, phase 2 trial
Patrick Gavin Kehoe, Nicholas Turner, Beth Howden, Lina Jarutyte, Shona Louise Clegg, Ian Brian Malone, Josephine Barnes, Casper Nielsen et al.. The Lancet. Neurology, 2021-11
Topic: Drug trials: efficacy and safety
Between July 22, 2014, and May 17, 2018, 261 participants entered the open-label phase. 211 were randomly assigned losartan (n=105) or placebo (n=106). Of 197 (93%) participants who completed the study, 171 (81%) had complete primary outcome data. The mean brain volume (BSI) reduction was 19·1 mL (SD 10·3) in the losartan group and 20·0 mL (10·8) in the placebo group. The difference in total volume reduction between groups was -2·29 mL (95% CI -6·46 to 0·89; p=0·14). The number of adverse events was low (22 in the losartan group and 20 in the placebo group) with no differences between treatment groups. There was one treatment-related death per treatment group. 12 months of treatment with losartan was well tolerated but was not effective in reducing the rate of brain atrophy in individuals with clinically diagnosed mild-to-moderate Alzheimer's disease. Further research is needed to assess the potential therapeutic benefit from earlier treatment in patients with milder cognitive impairment or from longer treatment periods. FUNDING: Efficacy and Mechanism Evaluation Programme (UK Medical Research Council and National Institute for Health Research).
Key findings
- Between July 22, 2014, and May 17, 2018, 261 participants entered the open-label phase. 211 were randomly assigned losartan (n=105) or placebo (n=106).
- Of 197 (93%) participants who completed the study, 171 (81%) had complete primary outcome data.
- The mean brain volume (BSI) reduction was 19·1 mL (SD 10·3) in the losartan group and 20·0 mL (10·8) in the placebo group.
- The difference in total volume reduction between groups was -2·29 mL (95% CI -6·46 to 0·89; p=0·14).
- The number of adverse events was low (22 in the losartan group and 20 in the placebo group) with no differences between treatment groups.
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Study details
- Study designrandomized controlled trial
- Participants105
- Evidence strengthHigh
How this study scored 83/100
Published in a leading specialty journal, and it is a randomised controlled trial. Scored zero for 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 and free to read, so those were left out: it earned 49 of the 59 points we could judge it on, which is 83 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (The Lancet. Neurology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomised 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 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 105 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) |
| Randomised / blinded | 2 / 2 | Randomised 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 |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 34687634) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 49 / 59 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 49 of the 59 points we could judge it on is 83 out of 100. |
| Total | 83 / 100 | — |
What each of these 20 components measures, and what this score is not →
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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
Kehoe, P. G., Turner, N., Howden, B., Jarutyte, L., Clegg, S. L., Malone, I. B., et al. (2021). Safety and efficacy of losartan for the reduction of brain atrophy in clinically diagnosed Alzheimer's disease (the RADAR trial): a double-blind, randomised, placebo-controlled, phase 2 trial. The Lancet. Neurology. https://doi.org/10.1016/s1474-4422(21)00263-5
Vancouver
Kehoe PG, Turner N, Howden B, Jarutyte L, Clegg SL, Malone IB, et al. Safety and efficacy of losartan for the reduction of brain atrophy in clinically diagnosed Alzheimer's disease (the RADAR trial): a double-blind, randomised, placebo-controlled, phase 2 trial. The Lancet. Neurology. 2021. doi:10.1016/s1474-4422(21)00263-5. PMID: 34687634.
BibTeX
@article{kehoe2021-34687634,
author = {Kehoe, Patrick Gavin and Turner, Nicholas and Howden, Beth and Jarutyte, Lina and Clegg, Shona Louise and Malone, Ian Brian and Barnes, Josephine and Nielsen, Casper and others},
title = {{Safety and efficacy of losartan for the reduction of brain atrophy in clinically diagnosed Alzheimer's disease (the RADAR trial): a double-blind, randomised, placebo-controlled, phase 2 trial}},
journal = {The Lancet. Neurology},
year = {2021},
doi = {10.1016/s1474-4422(21)00263-5},
pmid = {34687634},
url = {https://doi.org/10.1016/s1474-4422(21)00263-5}
}
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