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Therapeutic efficacy of pyritinol in patients with senile
dementia of the Alzheimer type (SDAT) and multi-infarct dementia
(MID).
Fischhof PK, Saletu B,
Rüther E, Litschauer G, Möslinger-Gehmayr R,
Herrmann WM.
Psychiatric Hospital Baumgartner Höhe, Vienna, Austria.
Neuropsychobiology.
1992;26(1-2):65-70.
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.
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