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

enting the interaction of beta amyloid with copper and zinc. MPACs have been shown to restore normal function to beta amyloid-impaired synapses and improve cognitive performance in mouse models of Alzheimer's.

Jeffrey L. Cummings, MD, of the David Geffen School of Medicine at UCLA, Los Angeles, CA, reports on a Phase IIa randomised, double-blind, placebo-controlled trial of PBT2 to assess the safety, tolerability, biochemical impact on the body, and preliminary efficacy of two different doses of the compound in patients with early Alzheimer's. This was done by (1) looking at how treatment with PBT2 changed the levels of proteins that are believed to be linked to Alzheimer's in the blood and spinal fluid (CSF) and (2) using memory and thinking tests to assess any change in the participants' mental capacity.

Seventy-eight (78) people with mild Alzheimer's (mean MMSE=22.9) were randomized to receive placebo (n=29), PBT2 50mg (n=20) or PBT2 250mg (n=29) capsules orally, once per day for 12 weeks. Biomarker assessment included the mean change from baseline to week 12 of proteins AB42 and AB40 in CSF. Preliminary efficacy assessments included the mean change from baseline to week 12 on a Neuropsychological Test Battery (NTB) and the ADAS-cog.

The researchers found that PBT2 250mg demonstrated a statistically significant reduction of CSF AB42 after 12 weeks of treatment compared with placebo (p=0.006), which was dose-dependent (p=0.023). PBT2 250mg demonstrated statistically significant improvements in both the Trail Making Test Part B and the Category Fluency Test (components of the NTB related to executive function) compared with placebo (p=0.009 and p=0.041, respectively). PBT2 had no effect on the ADAS-cog in this trial.

The researchers found the safety and tolerability profile to be similar between PBT2 and placebo. The overall withdrawal rate in the study was 5 percent, with no withdrawals attributed to adverse events. There were no seriou
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SOURCE Alzheimer's Association
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