Posatirelin for the treatment of late-onset Alzheimer's disease: a double-blind multicentre study vs citicoline and ascorbic acid

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Abstract
Introduction ‐ Posatirelin (L‐pyro‐2–aminoadipyl‐L‐leucil‐L‐prolinamide) a new synthetic tripeptide with cholinergic, catecholaminergic and neurotrophic properties, was investigated in the treatment of Alzheimer's disease. Material and methods ‐ A multicentre, double‐blind study vs citicoline (reference drug) and ascorbic acid (inactive drug) was carried out in elderly patients suffering from late‐onset Alzheimer's disease. The once daily intramuscular treatment lasted for three months followed by one‐month oral treatment with a placebo. Subscales and factors of GBS (Gottfries‐Bråne‐Steen) Rating Scale were identified as primary measures for efficacy assessment. Results ‐ At the end of the treatment, GBS subscale and factor scores assessing intellectual and emotional impairments, orientation and memory, ability to perform activities of daily living, depression‐anxiety, attention and motivation were improved in the posatirelin group, showing significant differences with respect to the citicoline and/or ascorbic acid groups. Tolerability was good in all groups. Conclusions ‐ The improvement in the GBS Rating Scale scores observed in the posatirelin group is clinically relevant. It is worth verifying the drug‐induced functional improvements, in further studies with large samples.