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| A Placebo-controlled, Double-blind Trial of the Selective Aß-42 Lowering Agent, Flurizan (MPC-7869, (R)-flurbiprofen) in Patients with Mild to Moderate Alzheimer’s Disease |
| Topic:
Pharmacological treatments |
| Presentation Time: Monday, 3:30 p.m. - 3:45 p.m. |
| Gordon K. Wilcock1, Sandra Black2, Judy Haworth3, Mark Laughlin4, Suzanne Hendrix4, Mary-Helen Binger4, Kenton Zavitz4, Edward Swabb4, Adrian Hobden4, 1University of Bristol, Bristol, United Kingdom; 2Sunnybrook & Women’s, University of Toronto, ON, Canada; 3North Bristol NHS Trust, Bristol, United Kingdom; 4Myriad Pharmaceuticals, Inc., Salt Lake City, UT, USA. Contact e-mail: gordon.wilcock@bris.ac.uk |
| Presentation Number: O2-01-05 |
| Keyword:
amyloid, beta-amyloid, clinical trials |
| Background: Several epidemiological studies have suggested that longer-term use of NSAIDs may reduce the risk of developing Alzheimer's disease (AD). Although there were encouraging results from some earlier studies, more recent longer-term, larger, placebo-controlled clinical trials utilising drugs with an anti-inflammatory action have produced disappointing outcomes. Re-analysis of the epidemiological data has shown that the protective effect is limited to a subgroup of NSAIDs, including flurbiprofen, which have Aß-42 lowering properties and which were not used in the previous longer-term placebo-controlled trials. Flurizan (MPC-7869 (R)-flurbiprofen) is a single enantiomer of flurbiprofen, which has been shown to lower brain levels of Aß-42 in a mouse model of AD (Tg2576), with some evidence of an effect on learning and memory. There is little risk of gastric toxicity because of a lack of anti-COX activity, and the compound has been shown to be safe and well tolerated in healthy older volunteers (55-80yrs) at doses of up to 1600mg per day when administered for 21 days in a phase I study. It is therefore an exciting potential disease modifying treatment for AD. Objective(s):This presentation will provide efficacy and safety data from a clinical trial of Flurizan, which to our knowledge will be the first multi-centre, placebo-controlled, double-blind clinical study of a selective Aß-42 lowering agent in patients with mild to moderate Alzheimer's disease. Methods:This is a one-year trial evaluating both 400mg BID and 800mg BID of (R)-flurbiprofen per day, in 210 patients (50% female) with mild to moderate AD (MMSE 15-26). It employed the ADAS-cog, ADCS-ADL, CDR-sb, CIBIC plus, NPI and MMSE as outcome measures. At baseline the mean age of the subjects was 75 years with an average MMSE score 21 and an average standard ADAS-cog score 23. Of the patients enrolled in the trial, 94 per cent were also taking stable doses of cholinesterase inhibitors. Concomitant treatment with memantine was not allowed.Conclusions:The study completes in March 2005, and the cognitive, functional, global and behavioural outcomes will be presented, together with the safety data. |
| Commercial Relationship: G.K. Wilcock, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F, S; S. Black, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F, S; J. Haworth, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F, S; M. Laughlin, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F; S. Hendrix, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F; M. Binger, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F; K. Zavitz, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F; E. Swabb, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F; A. Hobden, Myriad Pharmaceuticals, Inc.,Salt Lake City,Utah,USA F. |
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