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


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 postatirelin 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 score observed in the posatirelin group is clinically relevant. It is worth verifying the drug-induced functional improvements, in further studies with large samples.
D000368:Aged; D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy*; D001205:Ascorbic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D001921:Brain / Q000187:drug effects; D018678:Cholinergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003566:Cytidine Diphosphate Choline / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests; D012720:Severity of Illness Index; D013973:Thyrotropin-Releasing Hormone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use
D018678:Cholinergic Agents; D003566:Cytidine Diphosphate Choline; D013973:Thyrotropin-Releasing Hormone; C055448:posatirelin; D001205:Ascorbic Acid