Memantine Treatment in Patients With Moderate to Severe Alzheimer Disease Already Receiving Donepezil: A Randomized Controlled Trial
Abstract
CONTEXT: Memantine is a low- to moderate-affinity, uncompetitive N-methyl-D-aspartate receptor antagonist. Controlled trials have demonstrated the safety and efficacy of memantine monotherapy for patients with moderate to severe Alzheimer disease (AD) but no controlled trials of memantine in patients receiving a cholinesterase inhibitor have been performed. OBJECTIVE: To compare the efficacy and safety of memantine vs placebo in patients with moderate to severe AD already receiving stable treatment with donepezil. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled clinical trial of 404 patients with moderate to severe AD and Mini-Mental State Examination scores of 5 to 14, who received stable doses of donepezil, conducted at 37 US sites between June 11, 2001, and June 3, 2002. A total of 322 patients (80%) completed the trial. INTERVENTIONS: Participants were randomized to receive memantine (starting dose 5 mg/d, increased to 20 mg/d, n = 203) or placebo (n = 201) for 24 weeks. MAIN OUTCOME MEASURES: Change from baseline on the Severe Impairment Battery (SIB), a measure of cognition, and on a modified 19-item AD Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL19). Secondary outcomes included a Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), the Neuropsychiatric Inventory, and the Behavioral Rating Scale for Geriatric Patients (BGP Care Dependency Subscale). RESULTS: The change in total mean (SE) scores favored memantine vs placebo treatment for SIB (possible score range, 0-100), 0.9 (0.67) vs -2.5 (0.69), respectively (P<.001); ADCS-ADL19 (possible score range, 0-54), -2.0 (0.50) vs -3.4 (0.51), respectively (P =.03); and the CIBIC-Plus (possible score range, 1-7), 4.41 (0.074) vs 4.66 (0.075), respectively (P =.03). All other secondary measures showed significant benefits of memantine treatment. Treatment discontinuations because of adverse events for memantine vs placebo were 15 (7.4%) vs 25 (12.4%), respectively. CONCLUSIONS: In patients with moderate to severe AD receiving stable doses of donepezil, memantine resulted in significantly better outcomes than placebo on measures of cognition, activities of daily living, global outcome, and behavior and was well tolerated. These results, together with previous studies, suggest that memantine represents a new approach for the treatment of patients with moderate to severe AD.
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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 [120]
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- Authors
- Tariot, P. N., Farlow, M. R., Grossberg, G. T., Graham, S. M., McDonald, S., Gergel, I., & for the Memantine Study Group
- Affiliations
- University of Rochester Medicine (US)
- Saint Louis University (US)
- Forest Laboratories (United States) (US)
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2004-01-21
- Volume
- 291
- Issue
- 3
- Pages
- 317
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2132806643
- Cited by
- 1,403
- References
- 23
- Citations by year
- 2026: 29 · 2025: 41 · 2024: 42 · 2023: 26 · 2022: 39 · 2021: 58 · 2020: 27 · 2019: 45 · 2018: 32 · 2017: 34 · 2016: 44 · 2015: 63 · 2014: 63 · 2013: 65 · 2012: 80
- FWCI
- 79.74
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Aging (U19AG010483)
- 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, donepezil, Alzheimer's disease, NMDA receptor antagonists, cognitive impairment, activities of daily living, functional independence, behavioral symptoms, neuropsychiatric symptoms, adverse events, treatment safety, treatment efficacy, Severe Impairment Battery, CIBIC-Plus
- MeSH terms
- Donepezil, Aged, Alzheimer Disease, Cholinesterase Inhibitors, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Indans, Male, Memantine, Neuropsychological Tests, Piperidines, Severity of Illness Index, Dopamine Agents, Excitatory Amino Acid Antagonists, Nootropic Agents
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