of pyritinol in patients with senile dementia of the Alzheimer type (SDAT) and
multi-infarct dementia (MID).
Fischhof PK, Saletu B, Ruther E, Litschauer G,
Moslinger-Gehmayr R, Herrmann WM.
Psychiatric Hospital Baumgartner Hohe, Vienna, Austria.
This trial was performed to
investigate the efficacy of pyritinol in the treatment of senile dementia.
Initially, a total of 183 inpatients were screened for eligibility. Of 164
patients who met the inclusion criteria, 156 completed the trial. Allocation
of the patients to the Senile Dementia of the Alzheimer Type group or the
Multi-Infarct Dementia group was based on the Hachinski Ischemic Score,
computed tomography scans and electroencephalographic (EEG) findings. In a
12-week double-blind treatment phase either 200 mg pyritinol dihydrochloride-monohydrate
or placebo was given 3 times daily. Confirmatory statistics included item 2 of
the Clinical Global Impression, the total score of the Short Cognitive
Performance Test (Syndrom Kurz Test) and the factor 'cognitive disturbances'
of the Sandoz Clinical Assessment Geriatric scale. In addition, data on
tolerance, of EEG brain mapping and of a responder analysis were evaluated
based on descriptive statistics. The therapeutic efficacy of pyritinol was
clearly demonstrated by confirmatory analysis as the drug was statistically
significantly superior to placebo in all 3 target variables. The clinical
relevance of the outcome was underlined by the analysis of the descriptive
variables and by the convergence found at the different observation levels.
The EEG mapping demonstrated significant differences between placebo and
pyritinol, with the latter decreasing slow and increasing fast alpha and beta
activity, which reflects improvement of vigilance. Based on the results of
this trial, it can be accepted that the therapeutic effect of pyritinol is
superior to placebo in patients with mild to moderate dementia of both
degenerative and vascular etiology.