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Safety and tolerabi...
Safety and tolerability of BAN2401 - a clinical study in Alzheimer's disease with a protofibril selective A beta antibody
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- Logovinsky, Veronika (författare)
- Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ 07677 USA.
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- Satlin, Andrew (författare)
- Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ 07677 USA.
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- Lai, Robert (författare)
- Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ 07677 USA.
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- Swanson, Chad (författare)
- Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ 07677 USA.
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- Kaplow, June (författare)
- Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ 07677 USA.
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- Osswald, Gunilla (författare)
- BioArctic Neurosci AB, Warfvinges Vag 35, S-11251 Stockholm, Sweden.
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- Basun, Hans (författare)
- Uppsala universitet,Geriatrik,BioArctic Neurosci AB, Warfvinges Vag 35, S-11251 Stockholm, Sweden.
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- Lannfelt, Lars (författare)
- Uppsala universitet,Geriatrik,BioArctic Neurosci AB, Warfvinges Vag 35, S-11251 Stockholm, Sweden.
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Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ 07677 USA BioArctic Neurosci AB, Warfvinges Vag 35, S-11251 Stockholm, Sweden. (creator_code:org_t)
- 2016-04-06
- 2016
- Engelska.
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Ingår i: Alzheimer's Research & Therapy. - : Springer Science and Business Media LLC. - 1758-9193. ; 8
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://alzres.biome...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Background: Several monoclonal antibodies for the treatment of Alzheimer's disease (AD) have been in development over the last decade. BAN2401 is a monoclonal antibody that selectively binds soluble amyloid beta (A beta) protofibrils.Methods: Here we describe the first clinical study with BAN2401. Safety and tolerability were investigated in mild to moderate AD. A study design was used with staggered parallel single and multiple ascending doses, from 0.1 mg/kg as a single dose to 10 mg/kg biweekly for four months. The presence of amyloid related imaging abnormalities (ARIA, E for edema, H for hemorrhage) was assessed with magnetic resonance imaging (MRI). Cerebrospinal fluid (CSF) and plasma samples were analyzed to investigate pharmacokinetics (PK) and effects on biomarkers.Results: The incidence of ARIA-E/H on MRI was comparable to that of placebo. BAN2401 exposure was approximately dose proportional, with a serum terminal elimination half-life of similar to 7 days. Only a slight increase of plasma A beta((1-40)) was observed but there were no measurable effects of BAN2401 on CSF biomarkers. On the basis of these findings Phase 2b efficacy study has been initiated in early AD.Conclusions: BAN2401 was well-tolerated across all doses. The PK profile has guided us for selecting dose and dose regimens in the ongoing phase 2b study. There was no clear guidance for an effective dose based on biomarkers.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Geriatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Geriatrics (hsv//eng)
Nyckelord
- Alzheimer's disease
- Amyloid-beta
- A beta
- Protofibril
- Immunotherapy
- BAN2401
- mAb158
- ARIA
- Clinical trial
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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