PMID- 21561398 OWN - NLM STAT- MEDLINE DCOM- 20111101 LR - 20220317 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 27 IP - 7 DP - 2011 Jul TI - Tolerability and efficacy of memantine add-on therapy to rivastigmine transdermal patches in mild to moderate Alzheimer's disease: a multicenter, randomized, open-label, parallel-group study. PG - 1375-83 LID - 10.1185/03007995.2011.582484 [doi] AB - OBJECTIVE: To compare the tolerability and efficacy of combination therapy of memantine plus rivastigmine patch with rivastigmine patch monotherapy in patients with mild to moderate Alzheimer's disease (AD). RESEARCH DESIGN AND METHODS: In this multicenter, randomized, open-label study, patients entered an 8-week run-in period (a 5 cm 2 rivastigmine patch for 4 weeks, then a 10 cm(2) patch for 4 weeks) followed by 16 weeks of memantine plus rivastigmine patch or rivastigmine patch monotherapy. The primary outcome measure was the retention rate at the end of the trial. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov. NCT01025466. RESULTS: Overall, 88 and 84 patients received rivastigmine patch with and without memantine, respectively, and of these, 77 (87.5%) and 70 (83.3%) patients completed the study. The difference in retention rate was not significant (95% confidence interval: -6.3-14.7%). The incidence of adverse events (AEs) (53.4 vs. 50.6%) and discontinuation due to AEs (6.8 vs. 4.8%) were not different between patients with and without memantine. The most frequent AEs were skin irritation in patients with and without memantine (42.0 vs. 34.9%, p = 0.71), but discontinuation due to skin irritation was rare (4.5 vs. 2.4%, p = 0.74). The incidence of gastrointestinal AEs was very low in patients with and without memantine (nausea, 2.3 vs. 1.2%; vomiting, 1.1 vs. 1.2%). The Korean Version of the Cohen Mansfield Agitation Inventory scores favored rivastigmine patch monotherapy at the end of treatment (p = 0.01). Changes in other efficacy measures were similar between the groups. CONCLUSION: There were no significant differences in tolerability and safety between the treatment groups. The combination therapy of memantine plus rivastigmine patch did not show an advantage over rivastigmine patch monotherapy on efficacy analyses. The sample size for comparing tolerability may have been too small to detect a difference of efficacy between the two groups. FAU - Choi, Seong Hye AU - Choi SH AD - Department of Neurology, Inha University School of Medicine, Incheon, South Korea. FAU - Park, Kyung Won AU - Park KW FAU - Na, Duk L AU - Na DL FAU - Han, Hyun Jeong AU - Han HJ FAU - Kim, Eun-Joo AU - Kim EJ FAU - Shim, Yong S AU - Shim YS FAU - Lee, Jae-Hong AU - Lee JH CN - Expect Study Group LA - eng SI - ClinicalTrials.gov/NCT01025466 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20110512 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Antiparkinson Agents) RN - 0 (Neuroprotective Agents) RN - 0 (Phenylcarbamates) RN - PKI06M3IW0 (Rivastigmine) RN - W8O17SJF3T (Memantine) SB - IM MH - Administration, Cutaneous MH - Aged MH - Aged, 80 and over MH - Alzheimer Disease/*drug therapy MH - Antiparkinson Agents/administration & dosage/adverse effects MH - Drug Therapy, Combination MH - Female MH - Humans MH - Male MH - Memantine/*administration & dosage/*adverse effects MH - Middle Aged MH - Neuroprotective Agents/administration & dosage/adverse effects MH - Phenylcarbamates/*administration & dosage/adverse effects MH - Rivastigmine MH - Severity of Illness Index MH - Transdermal Patch MH - Treatment Outcome FIR - Kim, Byeong-Chae IR - Kim BC FIR - Na, Hae Ri IR - Na HR FIR - Lee, Jun-Young IR - Lee JY FIR - Moon, So Young IR - Moon SY FIR - Kwon, Jay C IR - Kwon JC FIR - Ryu, Seung-Ho IR - Ryu SH FIR - Kim, Jung Eun IR - Kim JE FIR - Ku, Bon D IR - Ku BD FIR - Kim, Shin Gyeom IR - Kim SG FIR - Park, Kee Hyung IR - Park KH FIR - Park, Key-Chung IR - Park KC FIR - Yoon, Soo Jin IR - Yoon SJ FIR - Park, Jong-Moo IR - Park JM FIR - Heo, Jae-Hyeok IR - Heo JH FIR - Choi, Mun Seong IR - Choi MS FIR - Yi, Hyon-Ah IR - Yi HA FIR - Park, Hyun Young IR - Park HY FIR - Shin, Joon-Hyun IR - Shin JH FIR - Cho, Soo Jin IR - Cho SJ EDAT- 2011/05/13 06:00 MHDA- 2011/11/02 06:00 CRDT- 2011/05/13 06:00 PHST- 2011/05/13 06:00 [entrez] PHST- 2011/05/13 06:00 [pubmed] PHST- 2011/11/02 06:00 [medline] AID - 10.1185/03007995.2011.582484 [doi] PST - ppublish SO - Curr Med Res Opin. 2011 Jul;27(7):1375-83. doi: 10.1185/03007995.2011.582484. Epub 2011 May 12.