Choline alphoscerate in cognitive decline and in acute cerebrovascular disease: an analysis of published clinical data

This paper has reviewed the documentation on the clinical efficacy of choli ne alphoscerate, a cholinergic precursor, considered as a centrally acting parasympathomimetic drug in dementia disorders and in acute cerebrovascular disease. Thirteen published clinical trials, examining in total 4054 patie nts, have evaluated the use of choline alphoscerate in various forms of dem entia disorders of degenerative, vascular or combined origin, such as senil e dementia of the Alzheimer's type (SDAT) or vascular dementia (VaD) and in acute cerebrovascular diseases, such as transitory ischemic attack (TIA) a nd stroke. Analysis has assessed the design of each study, in particular wi th respect to experimental design, number of cases, duration of treatment a nd tests used to evaluate drug clinical efficacy. Most of the ten studies p erformed in dementia disorders were controlled trials versus a reference dr ug or placebo. Overall, 1570 patients were assessed in these studies, 854 o f which in controlled trials. As detected by validated and appropriate test s, such as Mini Mental State Evaluation (MMSE) in SDAT and Sandoz Clinical Assessment Geriatric (SCAG) in VaD, administration of choline alphoscerate significantly improved patient clinical condition. Clinical results obtaine d with choline alphoscerate were superior or equivalent to those observed i n control groups under active treatment and superior to the results observe d in placebo groups. Analysis stresses the clear internal consistency of cl inical data gathered by different experimental situations on the drug effec t, especially with regard to the cognitive symptoms (memory, attention) cha racterising the clinical picture of adult-onset dementia disorders. The the rapeutic usefulness of choline alphoscerate in relieving cognitive symptoms of chronic cerebral deterioration differentiates this drug from cholinergi c precursors used in the past, such as choline and lecithin. Three uncontro lled trials were performed with choline alphoscerate in acute cerebrovascul ar stroke and TIA, totalling 2484 patients. The results of these trials sug gest that this drug might favour functional recovery of patients with cereb ral stroke and should be confirmed in future investigations aimed at establ ish the efficacy of the drug in achieving functional recovery of patients w ith acute cerebrovascular disease. (C) 2001 Elsevier Science Ireland Ltd. A ll ri-hts reserved.