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Four Alzheimer's Clinical Trials Address a Variety of Treatment Targets - Amyloid, Tau, Synapse Formation
Date:7/29/2008

y objective was to investigate the effects of oral MTC at 30, 60 and 100 mg doses three times per day, compared with placebo, over 24 weeks on cognitive function as measured by the ADAS-cog in patients with mild or moderate Alzheimer's, stratified by stage of the disease. Another objective was to determine MTC's potential to modify the course of Alzheimer's over 19 months. Imaging results from SPECT and PET scans were collected at baseline and after 24 weeks of treatment.

The researchers found that, at 24 weeks, MTC produced a significant improvement relative to placebo of -5.5 ADAS-cog units in moderate subjects at the 60 mg dose (p = 0.0208). There was no placebo decline in people with mild Alzheimer's in the control group over the first 24 weeks preventing initial efficacy analysis, although efficacy was demonstrated in mild Alzheimer's by SPECT-scan outcomes over the same period. MTC stabilized the progression of Alzheimer's over 50 weeks in both mild and moderate Alzheimer's. The overall effect size was -6.8 ADAS-cog units vs. decline of 7.8 units in the control arm (p < 0.0001), with significant efficacy demonstrated separately in mild and moderate subgroups.

According to the researchers, as a first approximation to supporting disease modifying efficacy, treatment with MTC at the 60mg dose produced a significantly larger effect size at 50 weeks than at 24 weeks implying an effect on the rate of cognitive decline (p = 0.0014). This was confirmed in a mixed effects slope analysis, showing an 81 percent reduction of long run rate of progression of decline over 50 weeks (p < 0.0001). The final 84-week analysis confirmed the long term effect of the 60mg dose in subjects remaining on treatment, with apparent decline still not significantly different from baseline at the final assessment, whereas there was significant decline in the other study arms.

The researchers added that brain imaging using SPECT and PET confirmed the clinical trial results
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SOURCE Alzheimer's Association
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