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Rivastigmine versus placebo in hyperhomocysteinemic Parkinson's disease dementia patients
Author(s) -
Barone Paolo,
Burn David J.,
van Laar Teus,
Hsu Chuanchieh,
Poewe Werner,
Lane Roger M.
Publication year - 2008
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.21997
Subject(s) - rivastigmine , placebo , dementia , homocysteine , medicine , adverse effect , psychology , gastroenterology , disease , donepezil , pathology , alternative medicine
The effects of rivastigmine versus placebo in Parkinson's disease dementia (PDD) patients with elevated or normal/low plasma homocysteine were determined. In this prospective analysis of a 24‐week, randomly assigned, placebo‐controlled study of rivastigmine in PDD, subpopulations comprised patients with plasma homocysteine ≥14 μmol/L (elevated) or <14 μmol/L (normal/low). Coprimary outcomes were the Alzheimer's Disease Assessment Scale–cognitive subscale (ADAS‐cog) and Alzheimer Disease Cooperative Society–Clinical Global Impression of Change (ADCS‐CGIC). Secondary outcomes included additional measures of cognition, including attention and executive function, daily function, and neuropsychiatric symptoms. Adverse events (AEs) were monitored. In total, 342 of 541 patients provided samples for analysis, from which 72% had elevated plasma homocysteine. Hyperhomocysteinemic patients showed treatment differences (rivastigmine vs. placebo) of 4.0 on ADAS‐cog and 0.7 on ADCS‐CGIC (both P < 0.01), and significant treatment differences on secondary outcomes. Rivastigmine‐ and placebo‐treated hyperhomocysteinemic patients (16.5% and 14.6%) discontinued the study because of AEs. Patients with normal/low homocysteine showed no treatment differences on primary or secondary outcomes (1.4 on the ADAS‐cog and 0.1 on ADCS‐CGIC, both P = ns); 16.7% and 10.3% rivastigmine‐ and placebo‐treated patients discontinued because of AEs. Elevated homocysteine was associated with greater rivastigmine treatment differences than normal/low homocysteine. © 2008 Movement Disorder Society