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Waldemar G., Hyvärinen M., Josiassen M. K., K Ø rner A., Lehto H. and Wetterberg P.

Tolerability of switching from donepezil to memantine treatment in patients with moderate to severe Alzheimer’s disease (AD). Waldemar G., Hyvärinen M., Josiassen M. K., K Ø rner A., Lehto H. and Wetterberg P. International Journal of Geriatric Psychiatry 2008, 23: 979-981.

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Waldemar G., Hyvärinen M., Josiassen M. K., K Ø rner A., Lehto H. and Wetterberg P.

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  1. Tolerability of switching from donepezil to memantine treatment in patients with moderate to severe Alzheimer’s disease (AD) Waldemar G., Hyvärinen M., Josiassen M. K., KØrner A., Lehto H. and Wetterberg P. International Journal of Geriatric Psychiatry 2008, 23: 979-981

  2. Study Design No. of patients N = 46 (outpatients) Diagnosis Probable Alzheimer’s disease Design Double-blind, randomized, placebo-controlled study Age ≥ 50 years Severity MMSE ≤ 18 Dose; duration 20 mg memantine/day; 8 weeks Outcome CGI-S, MMSE, CGI-C parameters Safety and tolerability Waldemar et al., Int J Geriatr Psychiatry 2008

  3. Study Design Memantine withstepwise discontinuation of Donepezil 5 mg/day Donepezil Memantinetitration W1 to W3 Memantine 20 mg/day W4 to W8 10 mg/day Donepezil Memantinetitration W1 to W3 Memantine 20 mg/day W4 to W8 Placebo Memantine with abrupt discontinuation of Donepezil W-1 W0 W2 W4 W6 W8 Screeningperiod Baseline Donepezil/placebo treatment stops Waldemar et al., Int J Geriatr Psychiatry 2008

  4. Disposition of Patients Patients screened N = 52 Screen failuresN = 5 (10%) Patients randomized N = 47 1 withdrawal of consent MEM (stepwise) N = 22 MEM (abrupt) N = 24 WithdrewN = 1(4%) Lack of efficacy CompletedN = 21(96%) CompletedN = 22(92%) WithdrewN = 2(8%) Adverse events Waldemar et al., Poster presented at EFNS 2005

  5. Baseline Characteristics Abrupt Group Stepwise Group N = 24 N = 22 Mean age,years (±SD) 76.5 (8.4) 79.9 (5.4) Gender, femaleN (%) 19 (79%) 18 (82%) MMSE score, mean (±SD) 13.4 (2.7) 13.0 (3.5) CGI-S score, mean (±SD) 5.2 (0.7) 5.1 (0.7) Waldemar et al., Int J Geriatr Psychiatry 2008

  6. Adverse Events 50 40 30 20 10 0 45.8 31.8 Memantine (stepwise) Memantine (abrupt) Percentage (%) 16.7 7 patients 11 patients 4 patients 0 Total number of patients with AEs AEs in Week 1 * * 2 Vertigo, 1 Athrosis, 1 Pruritus; none judged related to treatment Waldemar et al., Int J Geriatr Psychiatry 2008

  7. Adverse Events Most frequently reported adverse events (incidence ≥5%) MEM (abrupt) MEM (stepwise) No. of patients N = 24(100%) N = 22 (100%) Patients with AEs 11 (45.8%) 7 (31.8%) Accidental injury 1 (4.2%) 3 (13.6%)Anxiety 2 (8.3%) -Vertigo 2 (8.3%) - Waldemar et al., Int J Geriatr Psychiatry 2008

  8. Distribution of Patients by CGI Score at Week 8 74% Improved or No Change Worse 40 30 20 10 0 Memantine (stepwise) Memantine (abrupt) % of patients much improved slightly improved no change slightly worse much worse Waldemar et al., Poster presented at EFNS 2005

  9. Summary • Only 3 patients withdrew from the study (1 due to lack of efficacy, 2 due to AEs) • No clinically important differences in AEs between the two groups • No clinically important differences between the two groups in the incidence of potentially clinically significant vital signs or weight • After the switch to memantine 74% of the patients improved or were stabilized (CGI-C) • The safety and tolerability of switching AD patients from donepezil to memantine was good with either switching schedule • After being switched to memantine the majority of the patients either remained stable or improved Waldemar et al., Int J Geriatr Psychiatry 2008

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