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W Demencji Naczyniowej

W Demencji Naczyniowej. Preliminary results of the Russian phase IV trial ( randomized , double-blind, placebo-controlled ). 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.

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W Demencji Naczyniowej

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  1. W DemencjiNaczyniowej Preliminaryresults oftheRussianphase IV trial (randomized, double-blind, placebo-controlled)

  2. Schematbadania i dawkowanie 100mg acetylsalicylicacid 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. Efficacycriteria Primary efficacycriteria: ADAS-COG+change score frombaselinetoweek 24 (ITT; LOCF) CIBIC+ score distributionatweek 24 (ITT; LOCF) Secondaryefficacycriteria: MMSE, ADCS-ADL, Clock-Drawing Test, Trial-Making Test Safetycriteria: Adverseevents, vital signs, laboratorytests (hematology, bloodchemistry, urinalysis)

  4. Patient disposition

  5. Treatment differencefrombaseline (ADAS-COG+, ITT) ADAS-COG+ score LS Mean * -3.991 -2.743 *p<.0001; negative values are equivalent of improvement

  6. Treatment differencefrombaseline (ADAS-COG+, ITT: MMSE<=20) ADAS-COG+ score LS Mean -7.028 -6.678 + -5.602 -3.626 +p=0.0002; *p<.0001; negative values are equivalent of improvement

  7. EffectsofCerebrolysin on global function (CIBIC+, ITT, week 24) Values are n; p<.0001

  8. EffectsofCerebrolysin on global function (CIBIC+, ITT: MMSE<=20, week 24) Values are n; p<.0001

  9. In Alzheimer‘sDisease Preliminaryresults oftheSpanishphaseIV 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 Alzheimer’s Disease)

  10. 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. N=197. ITT data set.

  11. Figure 2 Shift analysis of the ADAS-cog+ score at week 28 for ITT analysis sets Funkcje kognitywne

  12. 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.

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