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Title: Effectiveness of Galantamine is Not Altered by Disease Severity: Presented at ANA

"Effectiveness of Galantamine is Not Altered by Disease Severity: Presented at ANA"

By Jill Stein Special to DG News NEW YORK CITY, NY -- October 14, 2002 -- Galantamine is effective in patients with Alzheimer's disease with cerebrovascular disease (AD+CVD) or probable vascular dementia (VaD) irrespective of baseline disease severity. Researchers reported the finding at the 127th Annual Meeting of the American Neurological Association (ANA). Galantamine, a novel therapy with a dual mode of action, amplifies the cholinergic response by modulating nicotinic receptors and reversibly inhibiting acetylcholinesterase. Dr. Gary Small, with University of California Los Angeles Neuropsychiatric Institute in Los Angeles, California, United States, presented data on 537 patients randomized to six months' treatment with galantamine, 24 mg/d, or placebo. Study participants had either probable VaD according to criteria from the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria--or possible AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Related Disorders Association (NINCDS-ADRDA) criteria, with significant radiologic evidence of CVD on computed tomography or g magnetic resonance imaging. The primary endpoints included the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus). A subgroup analysis was undertaken to assess the effects of galantamine in patients with mild compared with moderate disease. Mild disease was defined as an a score of less than or equal to 18 on the Mini-Mental Status Examination (MMSE), and moderate disease referred to an MMSE score less than 18. Galantamine showed significantly greater efficacy than placebo on ADAS-cog over six months. Patients treated with galantamine improved over baseline by 1.7 points, whereas those receiving placebo deteriorated by 1.0 points. Using the CIBIC plus as a measure of global functioning, 74 percent of galantamine-treated patients remained stable or improved after six months, compared with 59 percent of those receiving placebo. The portion of ADAS-cog responders in patients with either VaD or AD+CVD, defined as those patients with an improvement or no change in cognitive ability, was significantly greater in the galantamine versus the placebo group at sis months. At six months, patients with mild dementia showed significantly greater improvement on the ADAS-cog compared to patients with moderate dementia. Similarly, patients with mild dementia scored better on the Disability Assessment for Dementia and CIBIC-plus scales. However, these differences were not significant. Patients with moderate dementia still demonstrated greater improvement on all outcomes compared with placebo. Dr. Small said that the results indicate that galantamine shows broad clinical efficacy in patients with AD+CVD or probable VaD regardless of baseline disease severity. New treatments such as such as galantamine that have broad clinically relevant effects may have important clinical and economic benefits, potentially reducing caregiver burden and postponing institutionalization, he added. The study was sponsored by Janssen Pharmaceutica.

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