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Adeona Announces Positive Alzheimer's Subgroup Analysis that Supports Additional Clinical Study of Proprietary Zinc-Based Therapy
Date:6/2/2011

ared to the placebo patients of the same age.

These observations were supported by an age-related subgroup analysis that showed dosing-compliant patients age 70 and over (approximately the oldest three quartiles of the patients evaluable at the end of the study) demonstrated statistically significant improvements in two of the three cognitive scoring measurements in the reaZin treatment group compared to the placebo group. As presented below, in this subgroup, two of the three standard cognitive measures reached statistical significance (p < 0.05) as determined by the p-values (the average changes in cognitive scores from baseline to 6 months in the treatment group compared to the placebo group). The p-values were as follows:

  • ADAS-Cog - Alzheimer's Disease Assessment Scale - Cognitive Subscale p-value: 0.037
  • CDR-SOB - Clinical Dementia Rating Scale - Sum of Boxes p-value: 0.032
  • MMSE - Mini Mental State Examination p-value: 0.067

Based upon the apparent cognitive benefit observed in these older patients who were managed with reaZin in comparison to patients who received the matching placebo, Adeona is preparing a larger clinical study protocol to evaluate patients diagnosed with mild to moderate Alzheimer's disease who are age 70 and over. It is anticipated that the clinical study will enroll over 100 patients and that the evaluation period will be at least 12 months. The intention is to develop the Company's proprietary zinc-based tablet as a drug (in parallel with making reaZin available as a prescription medical food) and to conduct this new clinical study under an Investigational New Drug (IND) application to be filed with the Food & Drug Administration (FDA).

"The biological availability of zinc is impaired in Alzheimer's disease as evidenced by significantly lower plasma zinc levels and deficiencies of neuronal zinc activities, each of which
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SOURCE Adeona Pharmaceuticals, Inc.
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