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galantamine clinical trials

Galantamine in AD: Galantamine USA-1 Study Group [1] Treatment: - galantamine 24 or 32 mg QD vs placebo Results: 1) significant improvement in cognitive function relative to placebo, 3.8 points on ADAS cog/11 at 6 months (24 mg QD) 2) no change in cognitive function or activities of daily living at 12 months in galantamine group (24 mg QD) galantamine improves global & cognitive symptoms at doses > 16 mg/day, in patients with mild to moderate Alzheimer's disease for at least 6 months. [2] Two unnamed investigational trials [3] 2000 subjects Results: 1) no decrease in progression of MCI to dementia 2) linked to higher mortality (1.5% vs 0.5% for placebo) 3) about 1/2 of the REMINYL deaths appeared to result from various vascular causes (myocardial infarction, stroke), & sudden death * April 1, 2005: Ortho-McNeil Neurologics modified the PRECAUTIONS section of the Prescribing Information for Reminyl (galantamine).

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galantamine (Reminyl, Razadyne, Nivalin)

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clinical trial

References

  1. Raskind MA, Peskind ER, Wessel T, Yuan W, Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension. The Galantamine USA-1 Study Group. Neurology 54:2261, 2000 PMID: 10881250
  2. Cochrane Reviews http://www.cochrane.org/reviews/en/ab001747.html
  3. Internal Medicine News, March 1, 2005 FDA Medwatch http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Reminyl