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A phase 2 multiple ...
A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease.
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Salloway, S (author)
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Sperling, R (author)
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Gilman, S (author)
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Fox, N C (author)
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- Blennow, Kaj, 1958 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Raskind, M (author)
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Sabbagh, M (author)
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Honig, L S (author)
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Doody, R (author)
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van Dyck, C H (author)
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Mulnard, R (author)
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Barakos, J (author)
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Gregg, K M (author)
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Liu, E (author)
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Lieberburg, I (author)
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Schenk, D (author)
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Black, R (author)
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Grundman, M (author)
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(creator_code:org_t)
- 2009
- 2009
- English.
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In: Neurology. - 1526-632X. ; 73:24, s. 2061-70
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
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- 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 < 0.05, unadjusted for multiple comparisons) on cognitive and functional endpoints in study "completers" and APOE epsilon4 noncarriers. Reversible vasogenic edema, detected on brain MRI in 12/124 (9.7%) bapineuzumab-treated patients, was more frequent in higher dose groups and APOE epsilon4 carriers. Six vasogenic edema patients were asymptomatic; 6 experienced transient symptoms. 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Psykiatri (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Psychiatry (hsv//eng)
Keyword
- Aged
- Alzheimer Disease
- diagnosis
- drug therapy
- genetics
- psychology
- Antibodies
- Monoclonal
- administration & dosage
- adverse effects
- Apolipoprotein E4
- genetics
- Biological Markers
- cerebrospinal fluid
- Brain
- pathology
- Brain Edema
- chemically induced
- diagnosis
- Cognition
- drug effects
- Dose-Response Relationship
- Drug
- Female
- Heterozygote
- Humans
- Magnetic Resonance Imaging
- Male
- Severity of Illness Index
- Treatment Outcome
Publication and Content Type
- ref (subject category)
- art (subject category)
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Neurology
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- By the author/editor
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Salloway, S
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Sperling, R
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Gilman, S
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Fox, N C
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Blennow, Kaj, 19 ...
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Raskind, M
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show more...
-
Sabbagh, M
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Honig, L S
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Doody, R
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van Dyck, C H
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Mulnard, R
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Barakos, J
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Gregg, K M
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Liu, E
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Lieberburg, I
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Schenk, D
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Black, R
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Grundman, M
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Psychiatry
- Articles in the publication
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Neurology
- By the university
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University of Gothenburg