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Practical lessons from amyloid immunotherapy trials in Alzheimer disease
Solomon A, Akenine U, Andreasen N, Mangialasche F, Wimo A, Jelic V, Kivipelto M, Winblad B.. Current Alzheimer research, 2012-12-01
Topic: Amyloid, tau and blood-test diagnosis
Objectives Amyloid immunotherapy trials are central in Alzheimer disease (AD) drug development, with the potential to influence all future disease-modifying randomized controlled trials (RCTs). This study investigates practical experiences of staff and participants in immunotherapy RCTs. Setting and methods The Clinical Trial Research Unit of the Memory Clinic at Karolinska University Hospital, Sweden is an experienced centre specialized in Alzheimer RCTs, where four active and passive phase I/II immunotherapy trials are currently ongoing. Meetings were held with staff members, who were asked to describe their experiences and suggest necessary improvements. In addition, a pilot study was conducted to investigate motivations and expectations of participants in immunotherapy RCTs. A questionnaire was sent to 20 patients, and another similar questionnaire to their caregivers. Results The main issues emphasized by staff members concerned the critical window of opportunity for recruiting RCTs participants, the much higher level of effort required of patients and caregivers in immunotherapy RCTs compared to classical cholinesterase inhibitor RCTs, problematic informed consent procedures, and confidentiality limitations in trials with different sponsors. For patients and caregivers, the main reason for participating in RCTs was the wish to help research and other people, followed by the need for information, continuity of care, safety and support. Compared to patients, caregivers' expectations of trial results were more realistic. Conclusions More open debates of practical experiences from different trial centres and sponsors are essential for optimizing trial designs and improving conditions for participants.
Key findings
- Results The main issues emphasized by staff members concerned the critical window of opportunity for recruiting RCTs participants, the much higher level of effort required of patients and caregivers in immunotherapy RCTs compared to classical cholinesterase inhibitor RCTs, problematic informed consent procedures, and confidentiality limitations in trials with different sponsors.
- Compared to patients, caregivers' expectations of trial results were more realistic.
Why it matters
This study looked at the practical experiences of staff and participants in amyloid immunotherapy trials, not at whether the treatment works. It found that these trials demand much more effort from patients and caregivers than older cholinesterase inhibitor trials.
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Study details
- Participants20
- Evidence strengthHigh
How this study scored 50/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Current Alzheimer research) |
| Journal's citation record | 1 / 4 | Current Alzheimer Research: journal h-index 119 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised 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 | 1 / 5 | 2012 — within 20 year(s) of the newest study here |
| Sample size | 1 / 4 | 20 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 | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 2 / 7 | Cited 5 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.3 citations a year over 16 year(s) since 2012 |
| Impact for its field and year | 1 / 6 | Cited 0.2× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 0 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 4 / 4 | Last-listed author Bengt G. Winblad: h-index 171 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Karolinska Institutet: institution h-index 1,477 (OpenAlex) |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 1 institution(s) in 1 country — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 22631442) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 50 / 100 | — |
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Read the original
May need a subscription Unpaywall, Europe PMC and OpenAlex found no free copy of the full text (checked 10 Oct 2026), so the publisher may charge for it. The PubMed abstract is free.
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 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.
APA 7th
Solomon, A., Akenine, U., Andreasen, N., Mangialasche, F., Wimo, A., Jelic, V., et al. (2012). Practical lessons from amyloid immunotherapy trials in Alzheimer disease. Current Alzheimer research. https://doi.org/10.2174/156720512804142958
Vancouver
Solomon A, Akenine U, Andreasen N, Mangialasche F, Wimo A, Jelic V, et al. Practical lessons from amyloid immunotherapy trials in Alzheimer disease. Current Alzheimer research. 2012. doi:10.2174/156720512804142958. PMID: 22631442.
BibTeX
@article{solomon2012-22631442,
author = {Solomon, A. and Akenine, U. and Andreasen, N. and Mangialasche, F. and Wimo, A. and Jelic, V. and Kivipelto, M. and Winblad, B.},
title = {{Practical lessons from amyloid immunotherapy trials in Alzheimer disease}},
journal = {Current Alzheimer research},
year = {2012},
doi = {10.2174/156720512804142958},
pmid = {22631442},
url = {https://doi.org/10.2174/156720512804142958}
}