Renacenz Marketing Plan

1
W Demencji Naczyniowej
Preliminary results of the Russian phase IV
trial (randomized, double-blind,
placebo-controlled)
2
Schemat badania i dawkowanie
100mg acetylsalicylic acid PO, OD, 7d/w, 24 w
20ml Cerebrolysin/Placebo IV, OD, 5d/w, 4w (2x)
20 Infuzji
20 Infuzji
Tydzien 4
Tydzien 12
Tydzien 16
Tydzien 24
Start badania
Koniec badania
3
Efficacy criteria
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)
4
Patient disposition
5
Treatment difference from baseline (ADAS-COG,
ITT)
ADAS-COG score LS Mean

-3.991
-2.743
plt.0001 negative values are equivalent of
improvement
6
Treatment difference from baseline (ADAS-COG,
ITT MMSElt20)
ADAS-COG score LS Mean
-7.028
-6.678

-5.602
-3.626
p0.0002 plt.0001 negative values are
equivalent of improvement
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Effects of Cerebrolysin on global function
(CIBIC, ITT, week 24)
Values are n plt.0001
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Effects of Cerebrolysin on global function
(CIBIC, ITT MMSElt20, week 24)
Values are n plt.0001
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In Alzheimers Disease
Preliminary results of the Spanish phase IV
trial (A randomized , double-blind, clinical
trial to compare the safety and efficacy of
Cerebrolysin and Aricept (Donepezil) and a
combination therapy in patients with probable
Alzheimers Disease)
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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
13-16 tydzien badania
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. N197. ITT data set.
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Figure 2 Shift analysis of the ADAS-cog score
at week 28 for ITT analysis sets Funkcje
kognitywne
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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. N232. ITT data set.