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A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease
Salloway S, Sperling R, Gilman S, Fox NC, Blennow K, Raskind M, Sabbagh M, Honig LS et al.. Neurology, 2009-11-18
Topic: Amyloid, tau and blood-test diagnosis
Background Bapineuzumab, a humanized anti-amyloid-beta (Abeta) monoclonal antibody for the potential treatment of Alzheimer disease (AD), was evaluated in a multiple ascending dose, safety, and efficacy study in mild to moderate AD. Methods The study enrolled 234 patients, randomly assigned to IV bapineuzumab or placebo in 4 dose cohorts (0.15, 0.5, 1.0, or 2.0 mg/kg). Patients received 6 infusions, 13 weeks apart, with final assessments at week 78. The prespecified primary efficacy analysis in the modified intent-to-treat population assumed linear decline and compared treatment differences within dose cohorts on the Alzheimer's Disease Assessment Scale-Cognitive and Disability Assessment for Dementia. Exploratory analyses combined dose cohorts and did not assume a specific pattern of decline. Results No significant differences were found in the primary efficacy analysis. Exploratory analyses showed potential treatment differences (p Conclusions Primary efficacy outcomes in this phase 2 trial were not significant. Potential treatment differences in the exploratory analyses support further investigation of bapineuzumab in phase 3 with special attention to APOE epsilon4 carrier status. Classification of evidence Due to varying doses and a lack of statistical precision, this Class II ascending dose trial provides insufficient evidence to support or refute a benefit of bapineuzumab.
Key findings
- Results No significant differences were found in the primary efficacy analysis.
- Exploratory analyses showed potential treatment differences (p Conclusions Primary efficacy outcomes in this phase 2 trial were not significant.
Why it matters
In this phase 2 trial, 234 people with mild to moderate Alzheimer's disease were randomly assigned to placebo or one of four intravenous doses of bapineuzumab, an antibody against amyloid-beta, given every 13 weeks with final assessments at week 78. The main planned analysis found no significant difference from placebo on the cognition (ADAS-Cog) and daily-function (Disability Assessment for Dementia) scales, and the authors classed the trial as providing "insufficient evidence to support or refute a benefit." Possible differences seen only in exploratory analyses led the authors to recommend a phase 3 trial "with special attention to APOE epsilon4 carrier status"; on their own, these differences do not show that the drug works.
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Study details
- Study designclinical trial
- Participants234
- Effect sizeor 2.0
- Evidence strengthLow
How this study scored 74/100
Published in a leading specialty journal, and it is a mid-stage phase 2 trial.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | 4 / 4 | Neurology: journal h-index 525 (OpenAlex, 2026-10-29) |
| 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 | 2009 — within 20 year(s) of the newest study here |
| Sample size | 2 / 4 | 234 participants |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 6 / 7 | Cited 750 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 39.5 citations a year over 19 year(s) since 2009 |
| Impact for its field and year | 6 / 6 | Cited 49.7× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 4 / 6 | Cited by 51 other studies in this library |
| Still being cited | 3 / 4 | Cited 60 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 3 / 4 | Last-listed author Michael Grundman: h-index 59 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | University of Michigan: institution h-index 2,240 (OpenAlex) |
| Multi-centre collaboration | 3 / 3 | OpenAlex lists 10 institution(s) in 4 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 19923550) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 74 / 100 | — |
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Read the original
- DOI: 10.1212/wnl.0b013e3181c67808
- PubMed: 19923550
- Original source →
- Free full text: PubMed Central →
Full text: free to read — PubMed Central lists this copy as free to read: the link above (checked 10 Oct 2026).
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APA 7th
Salloway, S., Sperling, R., Gilman, S., Fox, N. C., Blennow, K., Raskind, M., et al. (2009). A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease. Neurology. https://doi.org/10.1212/wnl.0b013e3181c67808
Vancouver
Salloway S, Sperling R, Gilman S, Fox NC, Blennow K, Raskind M, et al. A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease. Neurology. 2009. doi:10.1212/wnl.0b013e3181c67808. PMID: 19923550.
BibTeX
@article{salloway2009-19923550,
author = {Salloway, S. and Sperling, R. and Gilman, S. and Fox, N. C. and Blennow, K. and Raskind, M. and Sabbagh, M. and Honig, L. S. and others},
title = {{A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease}},
journal = {Neurology},
year = {2009},
doi = {10.1212/wnl.0b013e3181c67808},
pmid = {19923550},
url = {https://doi.org/10.1212/wnl.0b013e3181c67808}
}
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