eprintid: 10052380
rev_number: 18
eprint_status: archive
userid: 608
dir: disk0/10/05/23/80
datestamp: 2018-07-17 09:10:57
lastmod: 2021-09-28 22:27:42
status_changed: 2018-07-17 09:10:57
type: article
metadata_visibility: show
creators_name: Salloway, SP
creators_name: Sperling, R
creators_name: Fox, NC
creators_name: Sabbagh, MN
creators_name: Honig, LS
creators_name: Porsteinsson, AP
creators_name: Rofael, H
creators_name: Ketter, N
creators_name: Wang, D
creators_name: Liu, E
creators_name: Carr, S
creators_name: Black, RS
creators_name: Brashear, HR
title: Long-Term Follow Up of Patients with Mild-to-Moderate Alzheimer's Disease Treated with Bapineuzumab in a Phase III, Open-Label, Extension Study
ispublished: pub
divisions: UCL
divisions: B02
divisions: C07
divisions: D07
divisions: F86
keywords: Alzheimer’s disease, amyloid-related imaging abnormality with edema/effusions, bapineuzumab, long-term safety
note: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
abstract: BACKGROUND: A 3-year extension of two Phase III parent studies of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer's disease dementia (apolipoprotein (APOE) ɛ4 carriers and noncarriers) is summarized. OBJECTIVES: The primary and secondary objectives were to evaluate the long-term safety, tolerability, and maintenance of efficacy of bapineuzumab. METHODS: A multicenter study in patients who had participated in double-blind placebo-controlled parent studies. Patients enrolled in the extension study were assigned to receive IV infusions of bapineuzumab (0.5 or 1.0 mg/kg) every 13 weeks until termination but were blinded to whether they had received bapineuzumab or placebo in the parent studies. RESULTS: A total of 1,462 (688 were APOEɛ4 carriers and 774 were noncarriers) patients were enrolled. Extension-onset adverse events occurred in >81% of the patients in each dose group. Fall, urinary tract infection, agitation, and ARIA-E occurred in ≥10% of participants. The incidence proportion of ARIA-E was higher among carriers and noncarriers who received bapineuzumab for the first time in the extension study (11.8% and 5.4%, respectively) versus those who were previously exposed in the parent studies (5.1% and 1.3%, respectively). After 6 to 12 months exposure to bapineuzumab IV in the extension study, similar deterioration of cognition and function occurred with no significant differences between the dose groups. CONCLUSIONS: Infusion of bapineuzumab 0.5 or 1.0 mg/kg every 13 weeks for up to 3 years was generally well tolerated, with a safety and tolerability profile similar to that in previous studies.
date: 2018
date_type: published
official_url: http://doi.org/10.3233/JAD-171157
oa_status: green
full_text_type: other
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 1564537
doi: 10.3233/JAD-171157
pii: JAD171157
lyricists_name: Fox, Nicholas
lyricists_id: NCIFO25
actors_name: Fox, Nicholas
actors_id: NCIFO25
actors_role: owner
full_text_status: public
publication: Journal of Alzheimer’s Disease
volume: 64
number: 3
pagerange: 689-707
event_location: Netherlands
issn: 1875-8908
citation:        Salloway, SP;    Sperling, R;    Fox, NC;    Sabbagh, MN;    Honig, LS;    Porsteinsson, AP;    Rofael, H;                         ... Brashear, HR; + view all <#>        Salloway, SP;  Sperling, R;  Fox, NC;  Sabbagh, MN;  Honig, LS;  Porsteinsson, AP;  Rofael, H;  Ketter, N;  Wang, D;  Liu, E;  Carr, S;  Black, RS;  Brashear, HR;   - view fewer <#>    (2018)    Long-Term Follow Up of Patients with Mild-to-Moderate Alzheimer's Disease Treated with Bapineuzumab in a Phase III, Open-Label, Extension Study.                   Journal of Alzheimer’s Disease , 64  (3)   pp. 689-707.    10.3233/JAD-171157 <https://doi.org/10.3233/JAD-171157>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10052380/1/Bapi%20351%20MS%20in%20JAD_Final%20proof_JAD171157.pdf