Posatirelin in the treatment of vascular dementia: A double-blind multicentre study vs placebo

Introduction - The usefulness of posatirelin (L-pyro-2-aminoadipyl-L-leucyl-1-prolinamide) , a synthetic peptide having modulatory activity on the monoaminergic and cholinergic systems and neurotrophic effects, was evaluated in vascular dementia. Patients and methods - A multicentre, parallel groups, double-blind clinical study vs placebo was carried out with patients suffering from probable vascular dementia according to the NINDS-AIREN criteria. The study consisted of a two-week run-in of a once daily, orally administered, placebo phase, followed by 12 weeks of intramuscular treatment with posatirelin 10 mg/ml or placebo given once a day and a follow-up after one month's withdrawal. Efficacy was assessed using the Gottries-Brane-Steen (GBS) Rating Scale for dementia, 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 significant improvement in intellectual performance; in orientation, motivation and memory as compared to controls. The improvement of memory performance was also confirmed by the acquisition score and memory index of the Randt Memory Test. At the-end of the follow-up period the differences between treatments were still maintained. Tolerability was good. Conclusions - The significant improvement observed in cognitive functions, attention and motivation of demented patients treated with posatirelin suggests the pootential usefulness of this drug in vascular dementia. Furthermore, the presence of a long-lasting effect after drug withdrawal suggests the possibility of administering the drug cyclically.