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Memantine Treatment in Patients with Mild to Moderate Alzheimers Disease Already Receiving a Cholinesterase Inhibitor: A Randomized, Double-Blind, Placebo-Controlled Trial
Abstract
OBJECTIVE: To evaluate the efficacy and safety of memantine in patients with mild to moderate Alzheimer's disease (AD) receiving cholinesterase inhibitor (ChEI) treatment. METHODS: Participants (N= 433) with probable AD, Mini-Mental State Exam (MMSE) scores between 10-22 (inclusive), and concurrent stable use of ChEIs (donepezil, rivastigmine, galantamine) were randomized to placebo or memantine (20 mg once daily) for 24 weeks. Primary outcomes were changes from baseline on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and on Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) score. Secondary measures comprised the 23-item Alzheimer Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL(23)), Neuropsychiatric Inventory (NPI), and MMSE. RESULTS: At the end of the trial, there were no statistically significant differences between the memantine- and placebo group on primary and secondary outcome measures. The incidence of adverse events (AEs) was similar between the two groups, with no AE occurring in more than 5% of memantine-treated patients and at a rate twice that of the placebo group. CONCLUSIONS: In this trial, memantine did not show an advantage over placebo based on protocol-specified primary or secondary analyses in patients with mild to moderate AD on stable ChEI regimens. There were no significant differences in tolerability and safety between the memantine- and placebo groups.
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“Short-term (6-12 months) RCTs (level I evidence), longer-term (12-36 months) openlabel extensions of RCTs (level II or III evidence), and long-term (2 to 5-plus years) observational prospective clinical cohort effectiveness studies (level II evidence) support the safety and benefits of anti-AD treatments in combination, most frequently as memantine added on to a stable regimen of background ChEI”
From The Alzheimer’s Disease Clinical Spectrum (2019) · cites this paper as [121]
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“9), which, similar to our study, included patients receiving concurrent ChEI treatment, showed no overall advantage of memantine on this measure [43].”
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“Keywords: Alzheimer’s disease, memantine, cholinesterase inhibitors, systematic review, meta-analysis”
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“But on the other hand, a more recent study investigating memantine in addition to one of three AChEIs did not show any clear cognitive or non-cognitive beneficial effects in AD patients [129].”
Memantine benefits functional abilities in moderate to severe Alzheimer's disease
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“…ADCS-ADL 23 scales (for the purposes of this paper, referred to as ADL 14 ), because three studies recruited patients with mild-to-moderate AD and therefore used the ADCS-ADL 23 (17, 18, 22) and three studies recruited patients with moderate-to-severe AD and therefore used the ADCS-ADL 19 (19-21).”
InfluentialAtri, A., Rountree, S. D., López, O. L., & Doody, R. S. (2012) · Neurodegenerative Diseases · doi:10.1159/000335156 · Cited by 23
Pyrimidine analogues for the management of neurodegenerative diseases
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MR Spectroscopy for Assessment of Memantine Treatment in Mild to Moderate Alzheimer Dementia
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“Memantine’s utility in treating moderate to severe AD has not been consistent in studies of patients with mild AD using standard cognitive and functional measures to assess cognitive decline [9].”
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“Overall, previous results based on changes from baseline in the total ADAS-cog score have supported the efficacy of memantine versus placebo in mild to moderate AD (Peskind et al., 2006; Bakchine and Loft, 2008; Porsteinsson et al., 2008).”
ResultDifferential Pharmacological Effects on Brain Reactivity and Plasticity in Alzheimer’s Disease
Brem, A., Atkinson, N. J., Seligson, E. E., & Pascual‐Leone, Á. (2013) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2013.00124 · Cited by 22
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BackgroundCombination Therapy for the Treatment of Alzheimer’s Disease: Recent Progress and Future Prospects
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“In our analysis, we regard MEM-MD-12 as the current study and the remaining trials as historical studies.”
InfluentialEffects of memantine treatment on language abilities and functional communication: A review of data
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“Post-hoc meta-analyses of data from two 24-week, randomized, double-blind, placebo-controlled trials [7, 8] reported that combination therapy with donepezil (10 mg/day) and memantine (20 mg/day) was associated with enhanced efficacy, without marked impact on safety and tolerability, compared with donepezil alone, in p…”
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“However, the second 24-week randomized trial, comprising 433 patients with mild to moderate AD, showed no significant difference between the group on cholinesterase inhibitor plus placebo and the group on cholinesterase inhibitor plus memantine.(22)”
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“Another randomized placebo-controlled clinical trial in individuals with mild to moderate AD using an AChEI (donepezil, galantamine or rivastigmine) revealed that memantine was no better than placebo on measures of cognition, behavior and functionality.(30) A meta-analysis of 6 clinical trials concluded that memantine…”
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The Pattern Element Scale: A Brief Tool of Traditional Medical Subtyping for Dementia
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“However, cholinesterase inhibitors and memantine, the currently available N-methyl-D-aspartate receptor antagonist, have a modest clinical effect on the symptoms and do not prevent the deterioration associated with dementia [2, 3].”
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“Second, two of the three prior adjunctive therapy studies showed benefit, and the citation used to indicate lack of replication refers to a study in patients with milder, rather than moderate to severe Alzheimer’s disease and is not pertinent.(8) This study achieved some very important results— that stopping donepezil…”
ResultTratamento da doença de Alzheimer
de Assis, F., do Vale, C., Neto, Y. C., Bertolucci, P. H. F., Machado, J. C., da Silva, D. J., Allam, N., & Balthazar, M. L. F. (2011) · Dementia & Neuropsychologia · Cited by 6
Memantin als Add-on-Medikation zur Acetylcholinesteraseinhibitor-Therapie bei Alzheimer-Demenz
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Metadata
- Authors
- Porsteinsson, A., Grossberg, G., Mintzer, J., & Olin, J.
- Affiliations
- University of Rochester Medicine (US)
- Venue
- Current Alzheimer Research
- Publisher
- Bentham Science Publishers Ltd.
- Published
- 2008-02-01
- Volume
- 5
- Issue
- 1
- Pages
- 83-89
- ISSN
- 1567-2050 (ISSN-L)
- OpenAlex
- W2149626554
- Cited by
- 272
- References
- 0
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 8 · 2023: 7 · 2022: 13 · 2021: 9 · 2020: 8 · 2019: 17 · 2018: 9 · 2017: 12 · 2016: 16 · 2015: 21 · 2014: 17 · 2013: 22 · 2012: 28
- FWCI
- 17.52
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Alzheimer Research (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Pharmacology (medical) › Cholinesterase and Neurodegenerative Diseases
- Keywords
- memantine, Alzheimer's disease, cholinesterase inhibitors, donepezil, rivastigmine, galantamine, combination therapy, cognitive function, activities of daily living, neuropsychiatric symptoms, drug safety, tolerability
- MeSH terms
- Activities of Daily Living, Aged, Aged, 80 and over, Alzheimer Disease, Cholinesterase Inhibitors, Double-Blind Method, Drug Therapy, Combination, Humans, Memantine, Mental Status Schedule, Middle Aged, Neuropsychological Tests, Prospective Studies, Severity of Illness Index, Receptors, N-Methyl-D-Aspartate, Treatment Outcome, Excitatory Amino Acid Antagonists
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