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 randomized controlled trials, longer-term open-label extensions, and long-term observational prospective clinical cohort effectiveness studies support the safety and benefits of anti-AD treatments in combination, most frequently as memantine added on to a stable regimen of background cholinesterase inhibitor treatment.
“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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An evaluation of memantine ER + donepezil for the treatment of Alzheimer’s disease
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“Memantine, an uncompetitive NMDA receptor antagonist, has been shown in clinical trials to be beneficial in patients with moderate to severe AD (Reisberg et al., 2003, 2006; Porsteinsson et al., 2008; Wang et al., 2013).”
BackgroundVitamin E and memantine in Alzheimer's disease: Clinical trial methods and baseline data
Dysken, M. W., Guarino, P., Vertrees, J. E., Asthana, S., Sano, M. C., Llorente, M. D., Pallaki, M., Love, S. B., Schellenberg, G. D., McCarten, J. R., et al. (2013) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2013.01.014 · Cited by 59 · see citing works
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Effectiveness and Safety of Memantine Treatment for Alzheimer's Disease
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“[ 35 ] R C T, m em an tin e”
Antidementia drug use among community-dwelling individuals with Alzheimer’s disease in Finland
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“Effectiveness and tolerability of concomitant use has been reported in the literature but is still under debate (Atri et al., 2008; Porsteinsson et al., 2008; Lopez et al., 2009).”
BackgroundA combination of galantamine and memantine modifies cognitive function in subjects with amnestic MCI
Peters, O., Lorenz, D., Fesche, A., Schmidtke, K., Hüll, M., Perneczky, R., Rüther, E., Möller, H. ‐., Jessen, F., Maier, W., et al. (2012) · The journal of nutrition health & aging · doi:10.1007/s12603-012-0062-8 · Cited by 55 · see citing works
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TREATMENT OF COGNITIVE DEFICITS IN ALZHEIMER'S DISEASE: A PSYCHOPHARMACOLOGICAL REVIEW
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Alzheimer's Therapeutics: Translation of Preclinical Science to Clinical Drug Development
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“However, another study demonstrated no additional benefits from combination therapy (Porsteinsson et al, 2008; see also Schneider et al, 2011).”
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“Acetylcholinesterase inhibitors (Birks and Grimley Evans, 2015) and memantine (Porsteinsson et al., 2008) are used to provide symptom relief.”
Background
- 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
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Pharmacology › 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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