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A 24-week randomized, controlled trial of memantine in patients with moderate-to-severe Alzheimer disease.
Alzheimer Dis Assoc Disord. 2007 Apr-Jun; 21(2):136-43.AD

Abstract

This study examined the efficacy and safety of memantine monotherapy in patients with moderate-to-severe Alzheimer disease (AD). Patients not receiving a cholinesterase inhibitor (N=350) were randomized to receive memantine (20 mg/d) or placebo during this 24-week, double-blind, placebo-controlled trial. Prospectively defined analyses failed to demonstrate a statistically significant benefit of memantine treatment compared with placebo on the Severe Impairment Battery (SIB) at week 24 end point, although a significant advantage was observed for memantine at weeks 12 and 18. The 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL19) did not differ significantly between groups in any analysis. Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-Plus) did not significantly favor memantine at week 24 despite a significant advantage for memantine at weeks 12 and 18. Other secondary outcomes showed no significant treatment differences. Post hoc analyses of potentially confounding covariates and alternative methods of imputing missing data did not substantially alter the results. Because of the violations of normality assumptions for the SIB and ADCS-ADL19, nonparametric analyses were performed; statistically significant benefit of memantine over placebo was demonstrated at week 24 for the SIB but not the ADCS-ADL19. The type and incidence of adverse events were similar in both groups.

Authors+Show Affiliations

Yale University School of Medicine, New Haven, CT 06510, USA. christopher.vandyck@yale.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17545739

Citation

van Dyck, Christopher H., et al. "A 24-week Randomized, Controlled Trial of Memantine in Patients With Moderate-to-severe Alzheimer Disease." Alzheimer Disease and Associated Disorders, vol. 21, no. 2, 2007, pp. 136-43.
van Dyck CH, Tariot PN, Meyers B, et al. A 24-week randomized, controlled trial of memantine in patients with moderate-to-severe Alzheimer disease. Alzheimer Dis Assoc Disord. 2007;21(2):136-43.
van Dyck, C. H., Tariot, P. N., Meyers, B., & Malca Resnick, E. (2007). A 24-week randomized, controlled trial of memantine in patients with moderate-to-severe Alzheimer disease. Alzheimer Disease and Associated Disorders, 21(2), 136-43.
van Dyck CH, et al. A 24-week Randomized, Controlled Trial of Memantine in Patients With Moderate-to-severe Alzheimer Disease. Alzheimer Dis Assoc Disord. 2007 Apr-Jun;21(2):136-43. PubMed PMID: 17545739.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 24-week randomized, controlled trial of memantine in patients with moderate-to-severe Alzheimer disease. AU - van Dyck,Christopher H, AU - Tariot,Pierre N, AU - Meyers,Barnett, AU - Malca Resnick,E, AU - ,, PY - 2007/6/5/pubmed PY - 2007/9/27/medline PY - 2007/6/5/entrez SP - 136 EP - 43 JF - Alzheimer disease and associated disorders JO - Alzheimer Dis Assoc Disord VL - 21 IS - 2 N2 - This study examined the efficacy and safety of memantine monotherapy in patients with moderate-to-severe Alzheimer disease (AD). Patients not receiving a cholinesterase inhibitor (N=350) were randomized to receive memantine (20 mg/d) or placebo during this 24-week, double-blind, placebo-controlled trial. Prospectively defined analyses failed to demonstrate a statistically significant benefit of memantine treatment compared with placebo on the Severe Impairment Battery (SIB) at week 24 end point, although a significant advantage was observed for memantine at weeks 12 and 18. The 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL19) did not differ significantly between groups in any analysis. Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-Plus) did not significantly favor memantine at week 24 despite a significant advantage for memantine at weeks 12 and 18. Other secondary outcomes showed no significant treatment differences. Post hoc analyses of potentially confounding covariates and alternative methods of imputing missing data did not substantially alter the results. Because of the violations of normality assumptions for the SIB and ADCS-ADL19, nonparametric analyses were performed; statistically significant benefit of memantine over placebo was demonstrated at week 24 for the SIB but not the ADCS-ADL19. The type and incidence of adverse events were similar in both groups. SN - 0893-0341 UR - https://www.unboundmedicine.com/medline/citation/17545739/A_24_week_randomized_controlled_trial_of_memantine_in_patients_with_moderate_to_severe_Alzheimer_disease_ DB - PRIME DP - Unbound Medicine ER -