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Galantamine treatment in Alzheimer's disease with cerebrovascular disease: responder analyses from a randomized, controlled trial (GAL-INT-6)

Memory Research Unit, Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland

S. Gauthier

McGill Center for Studies in Aging, Montreal, QC, Canada

R. Bullock

Kingshill Research Centre, Department of Old Age Psychiatry, Swindon, UK

A. Kurz

Technische Universität München, Munich, Germany

G. Hammond

Janssen-Cilag European Medical Affairs, High Wycombe, UK and Neuss Germany

S. Schwalen

Janssen-Cilag European Medical Affairs, High Wycombe, UK and Neuss Germany, sschwale{at}jacde.jnj.com

Y. Zhu

Ortho-McNeil Janssen Scientific Affairs, L.L.C., Titusville, NJ, USA

R. Brashear

Johnson & Johnson Pharmaceutical Research and Development, L.L.C., Titusville, NJ, USA

Alzheimer's disease combined with cerebrovascular disease (AD with CVD) is associated with progressive decline, with CVD impacting AD onset and severity of progression. Subjects with confirmed diagnosis of AD with CVD were treated with galantamine during a six-month, randomized, placebo-controlled trial (N = 285). Responder analyses were performed for cognitive, behavioural and functional outcome measures. Galantamine treatment resulted in significantly greater cognitive and functional improvements compared with placebo at six months, and a significantly higher percentage of treatment responders. The proportion of responders demonstrating improved or maintained cognition on the 11-item AD assessment scale-cognitive subscale (ADAS-cog/11) was 60.5% for galantamine versus 46.0% for placebo (P = 0.013). The proportion of patients responding by at least four-points on the ADAS-cog/11 was significantly greater for the galantamine group compared with placebo (33.6% versus 17.2%; P = 0.003). Seventy-five percent of galantamine-treated subjects improved or remained stable as assessed by CIBIC-plus compared with 53.6% on placebo (P = 0.0006). Significantly higher responder rates were observed with galantamine for behaviour (64.9% versus 56.6%; P = 0.024), and numerically favourable responder rates were seen with galantamine for activities of daily living. Treatment-emergent adverse events were generally related with the gastrointestinal system (nausea 20% versus 10%; vomiting 12% versus 5%; galantamine and placebo groups, respectively). Three deaths occurred during double-blind treatment: 2 of 188 subjects receiving galantamine, and 1 of 97 subjects receiving placebo. These findings are consistent with a broad range of cognitive, functional and behavioural benefits with galantamine across the spectrum of AD and AD with CVD.

Key Words: Alzheimer disease • dementia • cerebrovascular accident • cardiovascular diseases • vascular dementias • galantamine

This version was published on September 1, 2008

Journal of Psychopharmacology, Vol. 22, No. 7, 761-768 (2008)
DOI: 10.1177/0269881107083028


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