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For debate: substituting placebo controls in long-term Alzheimer's prevention trials
Spiegel R, Berres M, Miserez AR, Monsch AU, Alzheimer's Disease Neuroimaging Initiative.. Alzheimer's research & therapy, 2011-03-21
Topic: Amyloid, tau and blood-test diagnosis
Forecasted outcomes are compared with outcomes observed on candidate drugs, thus replacing a concomitant placebo group. Results ADAScog scores after 24 months are predicted from gender, obesity, Functional Assessment Questionnaire (FAQ) and baseline scores of Mini-Mental State Examination, ADAScog and NP-Batt with an R2 of 0.63 and a residual standard deviation of 0.67, allowing reasonably precise estimates of sample means. It is suggested that the PGSA may complement RPCT designs in forthcoming long-term drug studies with presymptomatic AD individuals.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Spiegel, R., Berres, M., Miserez, A. R., Monsch, A. U., & Alzheimer's Disease Neuroimaging Initiative. (2011). For debate: substituting placebo controls in long-term Alzheimer's prevention trials. Alzheimer's research & therapy. https://doi.org/10.1186/alzrt68
Vancouver
Spiegel R, Berres M, Miserez AR, Monsch AU, Alzheimer's Disease Neuroimaging Initiative. For debate: substituting placebo controls in long-term Alzheimer's prevention trials. Alzheimer's research & therapy. 2011. doi:10.1186/alzrt68. PMID: 21418632.
BibTeX
@article{spiegel2011-21418632,
author = {Spiegel, R. and Berres, M. and Miserez, A. R. and Monsch, A. U. and {Alzheimer's Disease Neuroimaging Initiative}},
title = {{For debate: substituting placebo controls in long-term Alzheimer's prevention trials}},
journal = {Alzheimer's research \& therapy},
year = {2011},
doi = {10.1186/alzrt68},
pmid = {21418632},
url = {https://doi.org/10.1186/alzrt68}
}
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Key findings
- Forecasted outcomes are compared with outcomes observed on candidate drugs, thus replacing a concomitant placebo group.
- Results ADAScog scores after 24 months are predicted from gender, obesity, Functional Assessment Questionnaire (FAQ) and baseline scores of Mini-Mental State Examination, ADAScog and NP-Batt with an R2 of 0.63 and a residual standard deviation of 0.67, allowing reasonably precise estimates of sample means.
- It is suggested that the PGSA may complement RPCT designs in forthcoming long-term drug studies with presymptomatic AD individuals.
Why it matters
This paper proposes using forecasted outcomes from historical data to partially replace placebo groups in long-term Alzheimer's prevention trials. It suggests this approach may complement randomized placebo-controlled trial designs in future studies with presymptomatic individuals.
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Study details
- Evidence strengthHigh
How this study scored 36/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / blinded because the record does not state it. We have no data on senior author's track record, so that was left out: it earned 35 of the 96 points we could judge it on, which is 36 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer's research & therapy) |
| Journal's citation record | 1 / 4 | Alzheimer s Research & Therapy: journal h-index 146 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (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 | 2011 — within 20 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 | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 3 / 7 | Cited 15 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.9 citations a year over 17 year(s) since 2011 |
| Impact for its field and year | 1 / 6 | Cited 1.0× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 3 other studies in this library |
| Still being cited | 0 / 4 | Cited 0 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | 0 / 3 | University Hospital of Basel: institution h-index 594 (OpenAlex) |
| Multi-centre collaboration | 1 / 3 | OpenAlex lists 2 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 21418632) |
| Free to read | 2 / 2 | Free to read |
| Points | 35 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 35 of the 96 points we could judge it on is 36 out of 100. |
| Total | 36 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1186/alzrt68
- PubMed: 21418632
- Original source →
- Free full text: Alzheimer s Research & Therapy →
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
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