Estudio multicéntrico controlado con placebo de la eficacia y tolerancia de idebenona en olvido benigno asociado a la edad

Background: memory loss is a frequent subjective complain observed during aging. Age associated memory impairment has now precise diagnostic criteria. A subgroup of patients with this disorder has an increased risk of progression to Alzheimer's disease, that is why a number of therapeutic efforts has been focused on its treatment. Objective: to evaluate the efficacy and safety of Idebenone in the treatment of patients with Age Associated Cognitive Impairment, specially through the evaluation of the effects of the drug on episodic (verbal and visual) and semantic memory. Design: multicenter prospective randomized placebo controlled study performed in 70 (seventy) patients of both sexes, ambulatory or institutionalized, aged between 50 to 75 years that fulfilled the criteria for Age Associated Memory Impairment Results: fifty six patients finished the study, 29 with Idebenone and 27 with placebo. At 120 days, a significant increase in the Weschler scale scores was seen in the patients who took Idebenone with respect to those on placebo (6.9 ′ 8.8 vs. 2.5 ′ 5.3; p < 0.04). A significant increase in the global phonologic scores (10.2 ′ 18.7 vs. 1.3 ′ 5.0; p < 0.03), and in phonologic fluency was also observed during the first 20 seconds (3.4 ′ 3.9 ′ vs. 0.6 ′ 3.0; p < 0.01). No differences were observed between groups in the phonologic fluency in the middle and final 20 seconds or in the test for semantic fluency. Finally, there was a significant increase in the Wais vocabulary test in the Idebenone group compared to placebo at 120 days (9.5 ′ 9.6 vs. 2.6 ′ 6.4; p < 0.004). Fourteen patients abandoned the study, 6 in the Idebenone group and 8 with placebo (17.1% vs. 22.8%; NS). In the Idebenone group, 3 patients abandoned due to side effects (dizziness, 1 patient; acatysia, 1 patient, and sleep disturbances, 1 patient) and 3 patients abandoned for personal reasons. In the placebo group, 6 patients abandoned due to side effects (2 for dizziness, 2 for flue-like symptoms, 1 for sleep disturbances, and 1 for gastric intolerance) and 2 patients for personal reasons. Conclusions: Idebenone showed a statistically significant improvement in some of the primary efficacy variables evaluated, suggesting that Idebenone has a therapeutic beneficial effect on the course of this disorder.