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Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life
Shaw EG, Rosdhal R, D'Agostino RB, Lovato J, Naughton MJ, Robbins ME, Rapp SR.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006-03-01
Topic: Drug trials: efficacy and safety
Purpose A prospective, open-label phase II study was conducted to determine whether donepezil, a US Food and Drug Administration-approved reversible acetylcholinesterase inhibitor used to treat mild to moderate Alzheimer's type dementia, improved cognitive functioning, mood, and quality of life (QOL) in irradiated brain tumor patients. Patients and methods Thirty-four patients received donepezil 5 mg/d for 6 weeks, then 10 mg/d for 18 weeks, followed by a washout period of 6 weeks off drug. Outcomes were assessed at baseline, 12, 24 (end of treatment), and 30 weeks (end of wash-out). All tests were administered by a trained research nurse. Results Of 35 patients who initiated the study, 24 patients (mean age, 45 years) remained on study for 24 weeks and completed all outcome assessments. All 24 patients had a primary brain tumor, mostly low-grade glioma. Scores significantly improved between baseline (pretreatment) and week 24 on measures of attention/concentration, verbal memory, and figural memory and a trend for verbal fluency (all P < .05). Confused mood also improved from baseline to 24 weeks (P = .004), with a trend for fatigue and anger (all P < .05). Health-related QOL improved significantly from baseline to 24 weeks, particularly, for brain specific concerns with a trend for improvement in emotional and social functioning (all P < .05). Conclusion Cognitive functioning, mood, and health-related QOL were significantly improved following a 24-week course of the acetylcholinesterase inhibitor donepezil. Toxicities were minimal. We are planning a double blinded, placebo-controlled, phase III trial of donepezil to confirm these favorable results.
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APA 7th
Shaw, E. G., Rosdhal, R., D'Agostino, R. B., Lovato, J., Naughton, M. J., Robbins, M. E., et al. (2006). Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. https://doi.org/10.1200/jco.2005.03.3001
Vancouver
Shaw EG, Rosdhal R, D'Agostino RB, Lovato J, Naughton MJ, Robbins ME, et al. Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2006. doi:10.1200/jco.2005.03.3001. PMID: 16549835.
BibTeX
@article{shaw2006-16549835,
author = {Shaw, E. G. and Rosdhal, R. and D'Agostino, R. B. and Lovato, J. and Naughton, M. J. and Robbins, M. E. and Rapp, SR.},
title = {{Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life}},
journal = {Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
year = {2006},
doi = {10.1200/jco.2005.03.3001},
pmid = {16549835},
url = {https://doi.org/10.1200/jco.2005.03.3001}
}
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 7 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.
Key findings
- Results Of 35 patients who initiated the study, 24 patients (mean age, 45 years) remained on study for 24 weeks and completed all outcome assessments.
- Scores significantly improved between baseline (pretreatment) and week 24 on measures of attention/concentration, verbal memory, and figural memory and a trend for verbal fluency (all P < .05).
- Health-related QOL improved significantly from baseline to 24 weeks, particularly, for brain specific concerns with a trend for improvement in emotional and social functioning (all P < .05).
- Conclusion Cognitive functioning, mood, and health-related QOL were significantly improved following a 24-week course of the acetylcholinesterase inhibitor donepezil.
- We are planning a double blinded, placebo-controlled, phase III trial of donepezil to confirm these favorable results.
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Study details
- Study designopen-label trial
- Participants35
- Evidence strengthLow
How this study scored 59/100
Published in a peer-reviewed journal, and it is a mid-stage phase 2 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 34 of the 58 points we could judge it on, which is 59 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of clinical oncology : official journal of the American Society of Clinical Oncology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 8 / 12 | A mid-stage phase 2 trial (from PubMed type “Clinical Trial, Phase II”) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2006 — older than 20 years, still counted |
| Sample size | 1 / 4 | 35 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 | 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 16549835) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 34 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 34 of the 58 points we could judge it on is 59 out of 100. |
| Total | 59 / 100 | — |
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