[Clinical stabilisation in neurodegenerative diseases: clinical study in phase II]

Neurodegenerative disorders, such as Parkinson's disease (PD), Alzheimer's disease (AD) and multiple sclerosis (MS), are progressive pathological conditions in which current treatments have not proved to be effective at curbing their progress (clinical stabilisation). Although they have very different clinical characteristics, they share the same pathophysiological mechanisms of progression. We developed a compound designed to obtain clinical stabilisation which acts by controlling cell damage due to aberrant apoptosis, oxidation, abnormal deposits of metals and proteins, and pathophysiological enzymatic pathways, such as that of caspases and the MAPK system.

Forty-two patients with AD, PD and MS were included in the study. The compound was administered to them every 12 hours and they were given appointments every three months for a clinical evaluation and a review of general lab analyses.

Subjects were submitted to a follow-up of between 3 and 24 months (mean: 8.85 +/- 5.99 months). No clinical side effects were recorded and there were only some slight alterations in the lab test results, although they were not clinically relevant. Clinical stabilisation was achieved in all the patients (100%) with MS and the scores on the Expanded Disability Status Scale improved in four patients (40%); clinical stabilisation in 17 patients (100%) with PD and improvements in the score on the Unified Parkinson's Disease Rating Scale in 15 of them (88.2%); and clinical stabilisation in 12 patients (100%) with AD, and an increase in the score obtained on the minimental test in nine cases (75%).

The compound is safe and a promising therapeutic option, since there is a clear tendency towards clinical stabilisation when it is being used. An experimental study needs to be conducted in order to determine the therapeutic scope of the compound and its possible preventive effects, as well as to evaluate other indications.