galantamine clinical trials
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Introduction
Galantamine in AD: Galantamine USA-1 Study Group[1]
Treatment:
- galantamine 24 or 32 mg QD vs placebo
Results:
- significant improvement in cognitive function relative to placebo, 3.8 points on ADAS cog/11 at 6 months (24 mg QD)
- 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:
- no decrease in progression of MCI to dementia
- linked to higher mortality (1.5% vs 0.5% for placebo)
- 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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References
- ↑ Jump up to: 1.0 1.1 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: https://www.ncbi.nlm.nih.gov/pubmed/10881250
- ↑ Jump up to: 2.0 2.1 Cochrane Reviews http://www.cochrane.org/reviews/en/ab001747.html
- ↑ Jump up to: 3.0 3.1 Internal Medicine News, March 1, 2005 FDA Medwatch http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Reminyl