| Disease | A PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL INVOLVING 40 PATIENTS SUFFERING FROM MODERATE DEMENTIA. SEVERITY OF THE DISEASE HAD TO CORRESPOND TO STAGES 4 OR 5 OF REISBERG'S GLOBAL DETERIORATION SCALE. INFUSIONS OF EITHER
EGB-761 OR PLACEBO WERE ADMINISTERED 4 DAYS PER WEEK FOR 4 WEEKS. PRIMARY OUTCOME MEASURE WAS THE ACTIVITIES OF DAILY LIVING AS ASSESSED BY THE NURNBERGER-ALTERS-BEOBACHTUNGSSKALA (NAB). THE CLINICAL GLOBAL IMPRESSIONS OF CHANGE (CGI, ITEM2)
AND THE ACTUAL INTELLIGENCE AS ASSESSED BY THE KURZTEST FUR ALLGEMEINE INTELLIGENZ (KAI) WERE FURTHER LARGER VARIABLES. NO RELEVANT GROUP DIFFERENCES COULD BE DETECTED AT BASELINE. AFTER THERAPY, PATIENTS OF THE ACTIVE SUBSTANCE GROUP SCORED
SIGNIFICANTLY BETTER (P < 0.05) ON EACH OUTCOME MEASURE THAN THOSE WHO RECEIVED PLACEBO. USING A SEQUENTIAL TESTING PROCEDURE, A GLOBAL SIGNIFICANCE LEVEL OF P < 0.05 COULD BE ASSURED. SUPERIORITY OF EGB-761 THERAPY WAS ALSO FOUND WITH RESPECT
TO A SELF-RATING SCALE FOR INSTRUMENTAL ACTIVITIES OF DAILY LIVING (NURNBERGER-ALTERS-ALLTAGSAKTIVITATENSKALA), THE IMPROVEMENT OF THE MOST PROMINENT SYMPTOM OF ILLNESS, AND THE DECREASE OF DEPRESSION. THUS, CLINICAL EFFICACY OF EGB-761 COULD
BE SHOWN ON 3 PLANES OF ASSESSMENT: THE BEHAVIORAL, THE PSYCHOPATHOLOGIC AND THE PSYCHOMETRIC PLANE. IT COULD BE CONFIRMED THAT, IN PATIENTS WITH MODERATE DEMENTIA, SHORT-TERM INTRAVENOUS INFUSION THERAPY WITH EGB-761 RESULTS IN AN
IMPROVEMENT OF PSYCHOPATHOLOGY AND COGNITIVE PERFORMANCE, WHICH IS REFLECTED IN AN INCREASED ABILITY TO COPE WITH THE DEMANDS OF DAILY LIVING.
A COMMERCIAL PRODUCT, EGB-761, WAS USED. |