[Randomized double-blind comparative study of minaprine (200mg/j) and of placebo on memory loss].
Thirty five subjects (age: 45-69 years) with subjective memory loss, without any other neuropsychiatric or somatic disease, were recruited in a phase II study. This double blind randomized versus placebo controlled study compared the effects of minaprine (200 mg/d) with placebo, in two parallel groups, during 2 months, on memory, attention and vigilance. Three psychometric tests were the main criteria of assessment: a standardized battery of memory tests (SM 5), the dual-coding test, the analysis of choice reaction times (CRT) and the critical flicker fusion point (CFF). A positive effect of minaprine was detected on words delayed recall (p = 0.028) and immediate recognition of words (p = 0.049). The global clinical tests (CGI, MacNair scale) were not statistically modified. Tolerability of minaprine and placebo were comparable. A positive pharmacodynamic activity on mnemonic performance is thus demonstrated in favour of minaprine (200 mg/d) in this specific population characterized by a memory complaint. These results would lead to a phase III study in which the main criteria would be global scales in order to confirm the clinical reliability of the present results.
Allain
H
H
Laboratoire de Pharmacologie Expérimentale et Clinique, Faculté de Médecine, Rennes, France.
Belliard
S
S
Lieury
A
A
Menard
G
G
Patat
A
A
Le Coz
F
F
Gandon
J M
JM
D000368:Aged; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008569:Memory Disorders / Q000188:drug therapy*; D008875:Middle Aged; D011724:Pyridazines / Q000009:adverse effects / Q000627:therapeutic use*
D000697:Central Nervous System Stimulants; D011724:Pyridazines; C006149:minaprine
Etude comparative en double aveugle randomisée de la minaprine (200 mg/j) et du placebo sur la plainte mnésique.