[Dihydroergocristine in the treatment of organic brain psychosyndrome. Dose-finding study against placebo].

Purpose of this study was to evaluate the activity of dihydroergocristine (DHEC, CAS 17479-19-5) at three different dosages, when administered to aged patients with senile dementia of Alzheimer type. Eighty patients, 48 males and 32 females, aged 55-80 years, affected with senile organic brain syndrome, were admitted to the trial. Clinical evaluation was made by SCAG (Sandoz Clinical Assessment Geriatric Scale). Inclusion criteria considered patients presenting at the basal evaluation a total SCAG score between 60 and 90, with stressed impairment of cognitive function. All the patients were divided in four groups and treated with DHEC 1.5, 3, 6 mg/d or placebo for three months. The evaluation of the total SCAG score demonstrated a significant activity of the drug compared vs placebo, and a dose-related effect. Also for the single clusters it was demonstrated a significant (p < 0.05) dose/effect relation, except for the "affective" one; on the contrary "cognitive functioning" cluster displayed the best benefit. The drug was very well tolerated, as only some cases of dyspepsia, mild gastralgia and nausea were reported in some patients.

RCT Entities:   Population Interventions Outcomes