POSATIRELIN IN THE TREATMENT OF VASCULAR DEMENTIA - A DOUBLE-BLIND MULTICENTER STUDY VS PLACEBO

Introduction - The usefulness of posatirelin (L-pyro-2-aminoadipyl-L-l eucyl-L-prolinamide), a synthetic peptide having modulatory activity o n the monoaminergic and cholinergic systems and neurotrophic effects, was evaluated in vascular dementia. Patients and methods - A multicent re, parallel groups, double-blind clinical study vs placebo was carrie d out with patients suffering from probable vascular dementia accordin g to eh NINDS-AIREN criteria. The study consisted of a two-week run-in of a once daily, orally administered, placebo phase, followed by 12 w eeks of intramuscular treatment with posatirelin 10 mg/ml or placebo g iven one a day and a follow-up after one month's withdrawal. Efficacy was assessed using the Gottfries-Brane-Steen (GBS) Rating Scale for de mentia, the Randt Memory Test and the Toulouse-Pieron Attention Test. Data were evaluated using analysis of variance and covariance. Results - As regards GBS scores, patients treated with posatirelin showed a s ignificant improvement in intellectual performance, in orientation, mo tivation and memory as compared to controls. The improvement of memory performance was also confirmed by the acquisition score and memory in dex of the Randt Memory Test. At the end of the follow-up period the d ifferences between treatments were still maintained. Tolerability was good. Conclusions - The significant improvement patients treated with posatirelin suggests the potential usefulness of this drug in vascular dementia. Furthermore, the presence of a long-lasting effect after dr ug withdrawal suggests the possibility of administering the drug cycli cally.