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62/100

✓ Peer-reviewed alzhub usefulness score 62 out of 100. Treatments

Topic: Drug trials: efficacy and safety

Plain-language summary

Introduction Solanezumab, a humanized monoclonal antibody that binds soluble amyloid beta peptide, is being developed for treatment of Alzheimer's disease (AD). Methods Patients (n = 2042) with mild and moderate AD were randomized 1:1 to 400-mg solanezumab or placebo infusion every 4 weeks for 80 weeks and 1457 patients entered an open-label extension. Magnetic resonance imaging scans monitored for amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemorrhage/hemosiderin deposition. Results Sixteen patients (solanezumab, n = 11; placebo, n = 5) developed ARIA-E during the double-blind phase, and 7 patients developed ARIA-E during the open-label extension as of July 31, 2014. Unique cases are discussed including solanezumab patients who were given solanezumab, while ARIA-E was present and a patient who developed ARIA-E during placebo treatment and again during solanezumab treatment. Discussion Asymptomatic ARIA-E was detected in solanezumab-treated and placebo-treated AD patients. ARIA-E occurs infrequently during solanezumab and placebo treatments but may occur repeatedly in some patients.

Cite this study APA, Vancouver, BibTeX · download .bib or .ris

APA 7th

Carlson, C., Siemers, E., Hake, A., Case, M., Hayduk, R., Suhy, J., et al. (2016). Amyloid-related imaging abnormalities from trials of solanezumab for Alzheimer's disease. Alzheimer's & dementia (Amsterdam, Netherlands). https://doi.org/10.1016/j.dadm.2016.02.004

Vancouver

Carlson C, Siemers E, Hake A, Case M, Hayduk R, Suhy J, et al. Amyloid-related imaging abnormalities from trials of solanezumab for Alzheimer's disease. Alzheimer's & dementia (Amsterdam, Netherlands). 2016. doi:10.1016/j.dadm.2016.02.004. PMID: 27239538.

BibTeX

@article{carlson2016-27239538,
  author  = {Carlson, C. and Siemers, E. and Hake, A. and Case, M. and Hayduk, R. and Suhy, J. and Oh, J. and Barakos, J.},
  title   = {{Amyloid-related imaging abnormalities from trials of solanezumab for Alzheimer's disease}},
  journal = {Alzheimer's \& dementia (Amsterdam, Netherlands)},
  year    = {2016},
  doi     = {10.1016/j.dadm.2016.02.004},
  pmid    = {27239538},
  url     = {https://doi.org/10.1016/j.dadm.2016.02.004}
}

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 8 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.

How to read this study

Design: this is a trial. Participants are assigned to a treatment or a comparison, so the key questions are who was enrolled, whether the comparison group got a placebo or nothing, how long people were followed, and whether the result is on a measure that matters to patients or on a biomarker. Open-label and small trials can overstate benefit.
Size: the record lists 2,042 participants. Ask whether that is enough for the question, and who they were.
Effect: the record gives no effect size, so the summary above cannot say how large any difference was.

What the evidence grade means here

This page is graded high. alzhub.org assigns the grade automatically from keywords in the abstract, not from reading the paper. High means the abstract mentions a randomized design, a meta-analysis or a systematic review. It can add at most 5 of the 100 points in the study score, and it is a label about design, not a verdict on whether the findings are true.

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Key findings

Results Sixteen patients (solanezumab, n = 11; placebo, n = 5) developed ARIA-E during the double-blind phase, and 7 patients developed ARIA-E during the open-label extension as of July 31, 2014.

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Study details

Study designopen-label trial
Participants2,042
Evidence strengthHigh

How this study scored 62/100

Published in a leading specialty journal. Scored zero for study design 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 and multicenter collaboration, so those were left out: it earned 36 of the 58 points we could judge it on, which is 62 out of 100.

Component	Points	Why
Journal tier	9 / 10	Tier 2 — leading specialty journal (Alzheimer's & dementia (Amsterdam, Netherlands))
Journal's citation record	— / 4	No journal record from OpenAlex — left out of this score
Study design	0 / 12	Design recorded as “open-label trial”, which our rubric does not rank (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	1 / 5	2016 — within 20 year(s) of the newest study here
Sample size	3 / 4	2,042 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	1 / 2	Randomized (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 27239538)
Free to read	2 / 2	Free to read
Points	36 / 58	Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 36 of the 58 points we could judge it on is 62 out of 100.
Total	62 / 100	—

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