Key result
Memantine ER added to cholinesterase inhibitors significantly increased the proportion of patients achieving and maintaining early clinical responses across cognitive and behavioral domains compared to placebo (P < 0.05).
Why the study?
Does memantine ER added to cholinesterase inhibitors improve and maintain cognitive and behavioral responses in patients with moderate to severe Alzheimer's disease?
RCT (n=676)
Double-blind
1:1
Yes
Does memantine ER added to cholinesterase inhibitors improve and maintain cognitive and behavioral responses in patients with moderate to severe Alzheimer's disease?
p-value: p=<0.05
Memantine ER added to cholinesterase inhibitors provides early and maintained improvements across multiple clinical domains in patients with moderate to severe Alzheimer's disease.
Supports adding memantine ER to cholinesterase inhibitors in moderate-severe AD; extends RCT evidence for sustained multi-domain responses.
Memantine extended release (ER) significantly outperformed placebo on co-primary endpoints of Clinician's Interview-based Impression of Change Plus Caregiver Input (CIBIC-Plus) and baseline to endpoint changes on the Severe Impairment Battery (SIB) in a 24-week, randomized trial (NCT00322153) in patients with moderate to severe Alzheimer's disease taking a cholinesterase inhibitor (ChEI). A post hoc analysis compared patients receiving memantine ER/ChEI to placebo/ChEI for time to onset of response and if the response was maintained (achieving improvement at weeks 8, 12, or 18 and maintaining through endpoint/week 24) on the SIB, the Neuropsychiatric Inventory (NPI), CIBIC-Plus, and Activities of Daily Living (ADL) using Fisher exact test. A second post hoc analysis compared percentages of patients for all possible combinations of 2 to 4 assessments with either no decline or clinically notable response using Wald χ. Significantly greater percentages of memantine ER/ChEI patients achieved an early response that was maintained on SIB, NPI, and CIBIC-Plus (P<0.05) versus placebo/ChEI. Significantly greater percentages of memantine ER/ChEI-treated patients achieved and maintained a clinically notable response on ADL/NPI, SIB/ADL/NPI, and SIB/ADL/CIBIC-Plus, compared with placebo/ChEI (P<0.05). Memantine ER results in early, maintained improvement in patients with moderate to severe Alzheimer's disease concurrently taking ChEIs, compared with cholinesterase treatment alone.
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Grossberg et al. (2018) conducted an RCT in Moderate to severe Alzheimer's disease (n=676). Memantine extended release (ER) vs. Placebo plus cholinesterase inhibitor (ChEI) was evaluated on Maintenance of early response (achieved at weeks 8, 12, or 18 and maintained through week 24) on SIB, NPI, and CIBIC-Plus (p=<0.05). Memantine ER added to cholinesterase inhibitors significantly increased the proportion of patients achieving and maintaining early clinical responses across cognitive and behavioral domains compared to placebo (P < 0.05).
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