clinical trial – Alzheimer’s disease – AEN-100

Based upon the apparent cognitive benefit observed in these older patients who were managed with reaZin (Adeona’s prescription medical food) 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 AEN-100, a zinc-based tablet, as a drug and to conduct this new clinical study under an Investigational New Drug application to be filed with the Food & Drug Administration.

Positive Alzheimer’s Subgroup Analysis Supports Additional Clinical Study of Proprietary Zinc-Based Therapy

After presenting the top-line results in April from the clinical study evaluating reaZin that demonstrated, on average, that the cognitive function (as measured by three standardized cognitive tests) of the patients managed with reaZin remained relatively stable over six months, while the placebo group showed deterioration, Adeona conducted further analyses to determine if certain subgroups in the patient sample benefitted from reaZin more than others.

After analyzing a number of independent variables associated with the patients enrolled in the clinical study on a post-hoc basis, the strongest relationship was found to be between age and cognitive outcomes. Patients in the study ranged from 52 to 86 years of age. Patients in the placebo group, on average, showed age-related cognitive decline – the older the patient, the greater the rate of cognitive decline. In contrast, patients in the reaZin treatment group, on average, showed cognitive stabilization, no matter what their age. Therefore, the older the reaZin treatment patient, the greater the amount of cognitive benefit compared 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