Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) announced that health authorities are reviewing scientific data from two clinical trials evaluating an investigational use of the company's Alzheimer's treatment, Reminyl (galantamine hydrobromide), in individuals with mild cognitive impairment.
Reminyl is an acetylcholinesterase inhibitor currently approved in 69 countries worldwide for treatment of mild to moderate Alzheimer's disease. No regulatory applications have been submitted for the potential use of Reminyl for the treatment of mild cognitive impairment anywhere in the world, nor are any planned.
The review was initiated as a result of a preliminary safety assessment of an imbalance of mortality in two mild cognitive impairment clinical trials submitted to health authorities worldwide by J&JPRD in August 2004. The clinical trial results also were presented last year at two international scientific forums: the International Congress of Alzheimer's Disease (ICAD) and the Alzheimer's Association Research Roundtable Mild Cognitive Impairment Meeting. J&JPRD has posted these results to the PhRMA clinical trials web site, http://www.clinicalstudyresults.org/.
Approximately 2,000 patients from 16 countries were enrolled in the GAL-INT-11 and GAL-INT-18 studies, which were designed to evaluate a potential decrease in the rate of progression from mild cognitive impairment to dementia in subjects treated with the drug.