Randomized placebo-controlled double-blind cross-over study on antihypoxidotic effects of piracetam using psychophysiological measures in healthy volunteers.

The effects of two acute doses (1600 mg, 2400 mg) of 2-oxo-pyrrolidine-1-acetamide (piracetam, Normabraïn) on hypoxia resistance were screened vs placebo in a randomized, double-blind 3-way change-over design in 9 healthy male volunteers (mean age: 26.4 +/- 3.5 years; mean body weight: 74.9 +/- 8.4 kg). Psychophysiological measurements were done with the oculodynamic test (ODT) for oculomotor, performatory and additional cardiorespiratory parameters. Intradiurnal assessments were done under normoxia (prevalue) and hypoxic hypoxidosis (1 hypoxic prevalue, 3 postdose values: 1.0, 2.5 and 4.0 h) with a content of 10.5% O2 and 89.5% N2 in inspired air (hypoxic hypoxidosis)--as a model of brain dysfunctions, related with several types of senile dementia (Primary Degenerative Dementia = Alzheimer type; Multi Infarct Dementia). The results indicate that piracetam especially in its higher dose (2400 mg) displays antihypoxidotic effects already after a single administration in oculomotor, performatory and cardiorespiratory parameters.

RCT Entities:   Population Interventions Outcomes