This paper has reviewed the documentation on the clinical efficacy of
choline 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 patients, have evaluated the use of
choline alphoscerate in various forms of
dementia disorders of degenerative, vascular or combined origin, such as
senile dementia of the Alzheimer's type (SDAT) or
vascular dementia (VaD) and in acute
cerebrovascular diseases, such as transitory ischemic attack (TIA) and
stroke. Analysis has assessed the design of each study, in particular with respect to experimental design, number of cases,
duration of treatment and tests used to evaluate
drug clinical efficacy. Most of the ten studies performed in
dementia disorders were controlled trials versus a reference
drug or placebo. Overall, 1570 patients were assessed in these studies, 854 of which in controlled trials. As detected by validated and appropriate tests, 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 obtained with
choline alphoscerate were superior or equivalent to those observed in control groups under active treatment and superior to the results observed in placebo groups. Analysis stresses the clear internal consistency of clinical data gathered by different experimental situations on the
drug effect, especially with regard to the
cognitive symptoms (memory, attention) characterising the clinical picture of adult-onset
dementia disorders. The therapeutic usefulness of
choline alphoscerate in relieving
cognitive symptoms of chronic cerebral deterioration differentiates this
drug from
cholinergic precursors used in the past, such as
choline and
lecithin. Three uncontrolled trials were performed with
choline alphoscerate in acute
cerebrovascular stroke and TIA, totalling 2484 patients. The results of these trials suggest that this
drug might favour functional recovery of patients with
cerebral stroke and should be confirmed in future investigations aimed at establish the efficacy of the
drug in achieving functional recovery of patients with acute
cerebrovascular disease.