W Demencji Naczyniowej
Start badania Tydzien 4 Tydzien 12 Tydzien 16 Tydzien 24 Koniec badania 20ml Cerebrolysin/Placebo IV, OD, 5d/w, 4w (2x) 20 Infuzji
Primary efficacy criteria: ADAS-COG + change score from baseline to week 24 (ITT; LOCF) CIBIC + score distribution at week 24 (ITT; LOCF) Secondary efficacy criteria: MMSE, ADCS-ADL, Clock-Drawing Test, Trial-Making Test Safety criteria: Adverse events, vital signs, laboratory tests (hematology, blood chemistry, urinalysis)
Randomized n=242 Cere 20ml n=121 No post-baseline data (n=4) ITT population n=117 Total discontinued (n=14) Consent withdrawn (10) Adverse event (2) Lack of efficacy (1) Other reason (1) Completed n=107 Placebo n=121 Received no medication (n=2) No post-baseline data (n=6) ITT population n=115 Total discontinued (n=11) Consent withdrawn (7) Administrative reason (1) Adverse event (2) Other reason (1) Completed n=110
* *p<.0001; negative values are equivalent of improvement ADAS-COG + score LS Mean
+ + p=0.0002; *p<.0001; negative values are equivalent of improvement ADAS-COG + score LS Mean
Values are n; p<.0001
In Alzheimers Disease
Figure 1 : Time course of the ADAS-cog+ treatment of different treatment groups (ITT analysis) Funkcje kognitywne. LS mean. There are no significant group differences. Negative score changes represent cognitive improvement from baseline. N=197. ITT data set. Dawkowanie: ARICEPT lub Placebo codziennie/raz dziennie przez caly okres badania Dawkowanie: CEREBROLYSIN lub Placebo jeden raz dziennie przez 5 dni w tygodniu w okresach 1-4 tydzien oraz tydzien badania
Figure 2 Shift analysis of the ADAS-cog+ score at week 28 for ITT analysis sets Funkcje kognitywne
Figure 3: CIBIC+ score at week 28 (ITT analysis) Aktywnosc ruchowa, sprawnosc na codzien Note: 1 = wyrazna poprawa. 2 = poprawa. 3 = minimalna poprawa. 4 = brak zmiany. 5 = minimalne pogorszenie. 6 = pogorszenie. 7 = wyrazne pogorszenie. N=232. ITT data set.