Posatirelin in the treatment of vascular dementia: a double-blind multicentre study vs placebo.
BACKGROUND
The usefulness of posatirelin (L-pyro-2-aminoadipyl-L-leucyl-L-prolinamide), a synthetic peptide having modulatory activity on the monoaminergic and cholinergic systems and neurotrophic effects, was evaluated in vascular dementia.


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 Gottfries-Bråne-Steen (GBS) Rating Scale for dementia, the Randt Memory Test and the Toulouse-Piéron 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 potential 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.
Parnetti
L
L
Perugia University, Italy.
Ambrosoli
L
L
Agliati
G
G
Caratozzolo
P
P
Fossati
L
L
Frattola
L
L
Martucci
N
N
Murri
L
L
Nappi
G
G
Puca
F M
FM
Poli
A
A
Girardello
R
R
Senin
U
U
D000368:Aged; D015140:Dementia, Vascular / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D013973:Thyrotropin-Releasing Hormone / Q000031:analogs & derivatives* / Q000627:therapeutic use
D013973:Thyrotropin-Releasing Hormone; C055448:posatirelin