Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease

Phase 3 Terminated 369 enrolled H. Lundbeck A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.

Timeline

Start: 2003-12
Primary completion: 2010-04
Completion: 2010-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Memantine vs Placebo; p = 0.418; Mean Difference (Final Values) 1.23 (95% CI -1.75 to 4.21); ANCOVA NCT00857649 ↗

registry analysis (superiority or other test); Memantine vs Placebo; p = 0.603; Mean Difference (Final Values) -0.48 (95% CI -2.30 to 1.34); ANCOVA NCT00857649 ↗

paper There were no statistically significant differences between memantine and placebo in mean change from baseline in NPI, SIB, or any of the secondary outcome measures. PMID 23472619 ↗

Publications

Results Herrmann N, Gauthier S, Boneva N, Lemming OM; 10158 Investigators. A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease. Int Psychogeriatr. 2013 Jun;25(6):919-27. doi: 10.1017/S1041610213000239. Epub 2013 Mar 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Memantine	Unknown	20 mg	Oral