Thirty five subjects (age: 45-69 years) with subjective memory loss, w
ithout any other neuropsychiatric or somatic disease, were recruited i
n a phase II study. This double blind randomized versus placebo contro
lled study compared the effects of minaprine (200 mg/d) with placebo,
in two parallel groups, during 2 months, on memory, attention and vigi
lance. Three psychometric tests were the main criteria of assessment:
a standardized battery of memory tests (SM 5), the dual-coding test, t
he analysis of choice reaction times (CRT) and the critical flicker fu
sion 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 statisti
cally modified. Tolerability of minaprine and placebo were comparable.
A positive pharmacodynamic activity on mnemonic performance is thus d
emonstrated in favour of minaprine (200 mg/d) in this specific populat
ion 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.