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A single ascending dose study of bapineuzumab in patients with Alzheimer disease
Black RS, Sperling RA, Safirstein B, Motter RN, Pallay A, Nichols A, Grundman M.. Alzheimer disease and associated disorders, 2010-04-01
Topic: Amyloid, tau and blood-test diagnosis
The safety, tolerability, and pharmacokinetics (PKs) of bapineuzumab (AAB-001), a humanized monoclonal antibody to amyloid beta, were evaluated in patients with mild-to-moderate Alzheimer disease in a phase 1, randomized, third-party unblinded, placebo-controlled, single ascending dose trial. Thirty patients received bapineuzumab infusion of 0.5, 1.5, or 5 mg/kg or placebo (6 active, 2 placebo for 0.5 and 1.5-mg/kg cohorts; 10 active, 4 placebo for 5.0-mg/kg cohort). Three patients in the highest dose cohort (5.0 mg/kg) developed magnetic resonance imaging abnormalities consistent with vasogenic edema, predominantly high signal abnormalities on fluid-attenuated inversion recovery sequences, all of which resolved over time. Plasma amyloid beta was elevated from baseline, peaking approximately 24 hours after infusion. PK analysis demonstrated a half-life of 21 to 26 days, supporting a 13-week dosing interval for bapineuzumab. This small, single-dose study demonstrated the safety profile and PK characteristics of bapineuzumab and was used to design later safety and efficacy trials.
Key findings
- PK analysis demonstrated a half-life of 21 to 26 days, supporting a 13-week dosing interval for bapineuzumab.
- This small, single-dose study demonstrated the safety profile and PK characteristics of bapineuzumab and was used to design later safety and efficacy trials.
Why it matters
This small phase 1 study tested single doses of bapineuzumab in patients with mild to moderate Alzheimer disease and found it was safe enough to support later trials, though some patients at the highest dose developed brain imaging abnormalities that resolved. It did not test whether the drug improves symptoms or changes the disease course.
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Study details
- Study designclinical trial
- Effect sizeor 0.5; or 5.0
- Evidence strengthHigh
How this study scored 58/100
Published in a peer-reviewed journal. Scored zero for study design and sample size because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Alzheimer disease and associated disorders) |
| Journal's citation record | 1 / 4 | Alzheimer Disease & Associated Disorders: journal h-index 131 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (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 | 2010 — 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 | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 3 / 3 | Studied in people (pubmed indexes it as a clinical or observational study) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 5 / 7 | Cited 168 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 9.3 citations a year over 18 year(s) since 2010 |
| Impact for its field and year | 4 / 6 | Cited 9.7× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 11 other studies in this library |
| Still being cited | 2 / 4 | Cited 26 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 | 3 / 3 | Harvard University: institution h-index 3,235 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 4 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 20505438) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 58 / 100 | — |
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Read the original
- DOI: 10.1097/wad.0b013e3181c53b00
- PubMed: 20505438
- 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).
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 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.
APA 7th
Black, R. S., Sperling, R. A., Safirstein, B., Motter, R. N., Pallay, A., Nichols, A., et al. (2010). A single ascending dose study of bapineuzumab in patients with Alzheimer disease. Alzheimer disease and associated disorders. https://doi.org/10.1097/wad.0b013e3181c53b00
Vancouver
Black RS, Sperling RA, Safirstein B, Motter RN, Pallay A, Nichols A, et al. A single ascending dose study of bapineuzumab in patients with Alzheimer disease. Alzheimer disease and associated disorders. 2010. doi:10.1097/wad.0b013e3181c53b00. PMID: 20505438.
BibTeX
@article{black2010-20505438,
author = {Black, R. S. and Sperling, R. A. and Safirstein, B. and Motter, R. N. and Pallay, A. and Nichols, A. and Grundman, M.},
title = {{A single ascending dose study of bapineuzumab in patients with Alzheimer disease}},
journal = {Alzheimer disease and associated disorders},
year = {2010},
doi = {10.1097/wad.0b013e3181c53b00},
pmid = {20505438},
url = {https://doi.org/10.1097/wad.0b013e3181c53b00}
}
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