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78/100

✓ Peer-reviewed alzhub usefulness score 78 out of 100. Clinical trials

Topic: Brain imaging, connectivity and assessment

Plain-language summary

Background Long acting insulin detemir administered intranasally for three weeks enhanced memory for adults with Alzheimer's disease dementia (AD) or amnestic mild cognitive impairment (MCI). The investigation of longer-term administration is necessary to determine whether benefits persist, whether they are similar to benefits provided by regular insulin, and whether either form of insulin therapy affects AD biomarkers. Objective The present study aimed to determine whether four months of treatment with intranasal insulin detemir or regular insulin improves cognition, daily functioning, and AD biomarkers for adults with MCI or AD. Methods This randomized, double-blind, placebo-controlled trial included an intent-to-treat sample consisting of 36 adults diagnosed with MCI or mild to moderate AD. Participants received placebo (n = 12), 40 IU of insulin detemir (n = 12), or 40 IU of regular insulin (n = 12) daily for four months, administered with a nasal delivery device. A cognitive battery was administered at baseline and after two and four months of treatment. MRI was administered for all participants and lumbar puncture for a subset (n = 20) at baseline and four months. The primary outcome was change from baseline to four months on a memory composite (sum of Z scores for delayed list and story recall). Secondary outcomes included: global cognition (Alzheimer's Disease Assessment Scale-Cognition), daily functioning (Dementia Severity Rating Scale), MRI volume changes in AD-related regions of interest, and cerebrospinal fluid AD markers. Results The regular insulin treated group had better memory after two and four months compared with placebo (p < 0.03). No significant effects were observed for the detemir-assigned group compared with the placebo group, or for daily functioning for either group. Regular insulin treatment was associated with preserved volume on MRI. Regular insulin treatment was also associated with reduction in the tau-P181/Aβ42 ratio. Conclusion Future research is warranted to examine the mechanistic basis of treatment differences, and to further assess the efficacy and safety of intranasal insulin.

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

APA 7th

Craft, S., Claxton, A., Baker, L. D., Hanson, A. J., Cholerton, B., Trittschuh, E. H., et al. (2017). Effects of Regular and Long-Acting Insulin on Cognition and Alzheimer's Disease Biomarkers: A Pilot Clinical Trial. Journal of Alzheimer's disease : JAD. https://doi.org/10.3233/jad-161256

Vancouver

Craft S, Claxton A, Baker LD, Hanson AJ, Cholerton B, Trittschuh EH, et al. Effects of Regular and Long-Acting Insulin on Cognition and Alzheimer's Disease Biomarkers: A Pilot Clinical Trial. Journal of Alzheimer's disease : JAD. 2017. doi:10.3233/jad-161256. PMID: 28372335.

BibTeX

@article{craft2017-28372335,
  author  = {Craft, S. and Claxton, A. and Baker, L. D. and Hanson, A. J. and Cholerton, B. and Trittschuh, E. H. and Dahl, D. and Caulder, E. and others},
  title   = {{Effects of Regular and Long-Acting Insulin on Cognition and Alzheimer's Disease Biomarkers: A Pilot Clinical Trial}},
  journal = {Journal of Alzheimer's disease : JAD},
  year    = {2017},
  doi     = {10.3233/jad-161256},
  pmid    = {28372335},
  url     = {https://doi.org/10.3233/jad-161256}
}

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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 12 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 The regular insulin treated group had better memory after two and four months compared with placebo (p < 0.03).
No significant effects were observed for the detemir-assigned group compared with the placebo group, or for daily functioning for either group.
Regular insulin treatment was associated with preserved volume on MRI.
Regular insulin treatment was also associated with reduction in the tau-P181/Aβ42 ratio.

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Study details

Participants12
Evidence strengthHigh

How this study scored 78/100

Published in a peer-reviewed journal, and it is a randomized 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 multicenter collaboration, so those were left out: it earned 45 of the 58 points we could judge it on, which is 78 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	2 / 5	2017 — within 10 year(s) of the newest study here
Sample size	1 / 4	12 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	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 28372335)
Free to read	2 / 2	Free to read
Points	45 / 58	Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 45 of the 58 points we could judge it on is 78 out of 100.
Total	78 / 100	—

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