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Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease
Blennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, Grundman M, Liu E et al.. Archives of neurology, 2012-08-01
Topic: Amyloid, tau and blood-test diagnosis
Background Given the slow and variable clinical course of Alzheimer disease, very large and extended clinical trials are needed to identify a beneficial clinical effect of disease-modifying treatments. Therefore, biomarkers are essential to prove that an anti-β-amyloid (Aβ) drug candidate affects both Aβ metabolism and plaque load as well as downstream pathogenic mechanisms. Objective To evaluate the effect of the anti-Aβ monoclonal antibody bapineuzumab on cerebrospinal fluid (CSF) biomarkers reflecting Aβ homeostasis, neuronal degeneration, and tau-related pathology in patients with Alzheimer disease. Design Two phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trials of 12-month duration. Setting Academic centers in the United States (Study 201) and England and Finland (Study 202). Patients Forty-six patients with mild to moderate Alzheimer disease. Interventions Patients received either placebo (n = 19) or bapineuzumab (n = 27) in 3 or 4 ascending dose groups. Main outcome measures Changes between end of study and baseline in the exploratory CSF biomarkers Aβ1-42, AβX-42, AβX-40; total tau (T-tau); and phosphorylated tau (P-tau). Results Within the bapineuzumab group, a decrease at end of study compared with baseline was found both for CSF T-tau (-72.3 pg/mL) and P-tau (-9.9 pg/mL). When comparing the treatment and placebo groups, this difference was statistically significant for P-tau (P = .03), while a similar trend for a decrease was found for T-tau (P = .09). No clear-cut differences were observed for CSF Aβ. Conclusions To our knowledge, this study is the first to show that passive Aβ immunotherapy with bapineuzumab results in decreases in CSF T-tau and P-tau, which may indicate downstream effects on the degenerative process. Cerebrospinal fluid biomarkers may be useful to monitor the effects of novel disease-modifying anti-Aβ drugs in clinical trials. TRIAL REGISTRATIONS clinicaltrials.gov Identifier: NCT00112073, EudraCT Identifier: 2004-004120-12, and isrctn.org Identifier: ISRCTN17517446.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Blennow, K., Zetterberg, H., Rinne, J. O., Salloway, S., Wei, J., Black, R., et al. (2012). Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Archives of neurology. https://doi.org/10.1001/archneurol.2012.90
Vancouver
Blennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, et al. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Archives of neurology. 2012. doi:10.1001/archneurol.2012.90. PMID: 22473769.
BibTeX
@article{blennow2012-22473769,
author = {Blennow, K. and Zetterberg, H. and Rinne, J. O. and Salloway, S. and Wei, J. and Black, R. and Grundman, M. and Liu, E. and others},
title = {{Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease}},
journal = {Archives of neurology},
year = {2012},
doi = {10.1001/archneurol.2012.90},
pmid = {22473769},
url = {https://doi.org/10.1001/archneurol.2012.90}
}
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Key findings
- Results Within the bapineuzumab group, a decrease at end of study compared with baseline was found both for CSF T-tau (-72.3 pg/mL) and P-tau (-9.9 pg/mL).
- When comparing the treatment and placebo groups, this difference was statistically significant for P-tau (P = .03), while a similar trend for a decrease was found for T-tau (P = .09).
- Conclusions To our knowledge, this study is the first to show that passive Aβ immunotherapy with bapineuzumab results in decreases in CSF T-tau and P-tau, which may indicate downstream effects on the degenerative process.
Why it matters
In these phase 2 trials, bapineuzumab was associated with a decrease in cerebrospinal fluid T-tau and P-tau compared to baseline, with the difference reaching statistical significance for P-tau. This shows an effect on biomarkers of neuronal degeneration and tau-related pathology, not on clinical outcomes.
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Study details
- Study designclinical trial
- Participants19
- Evidence strengthHigh
How this study scored 68/100
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 senior author's track record, so that was left out: it earned 65 of the 96 points we could judge it on, which is 68 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Archives of neurology) |
| Journal's citation record | 3 / 4 | Archives of Neurology: journal h-index 353 (OpenAlex, 2026-10-29) |
| 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 | 1 / 5 | 2012 — within 20 year(s) of the newest study here |
| Sample size | 1 / 4 | 19 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 | 5 / 7 | Cited 234 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 14.6 citations a year over 16 year(s) since 2012 |
| Impact for its field and year | 5 / 6 | Cited 23.8× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 17 other studies in this library |
| Still being cited | 1 / 4 | Cited 11 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 | 1 / 3 | University of Gothenburg: institution h-index 972 (OpenAlex) |
| Multicenter collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 22473769) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 65 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 65 of the 96 points we could judge it on is 68 out of 100. |
| Total | 68 / 100 | — |
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