The Efficacy & Safety of Namzaric®in Treating Alzheimer's

 

 

What is it?

Namzaric is a well-studied, FDA-approved medication for moderate to severe Alzheimer’s, that combines two drugs in one pill: donepezil (Aricept) and memantine (Namenda). Donepezil helps improve communication between brain cells by increasing a chemical called acetylcholine. Memantine protects brain cells by regulating glutamate, a chemical that can cause damage when too active. It can help improve symptoms related to memory and daily life, but does not stop the disease itself. Side effects are usually manageable.

 

How large was treatment effect? 

There is clinical-trial evidence that Namzaric (via its components memantine ER + donepezil) can produce small, statistically significant improvements in cognition and global clinical status in patients with moderate-to-severe dementia (typically Alzheimer’s) over about 6 months. (1,2,3,4)

 

The average magnitude of benefit is modest (e.g., +2–3 points on SIB), and functional/daily-living improvements are less robust or inconsistent.

 

The evidence does not reliably support large or dramatic improvements in “memory, attention, everyday functioning” across all or most patients.

 

 

 

Number Needed to Treat (NNT)

There is evidence supporting a clinically meaningful benefit of memantine (or memantine + donepezil) for some patients with moderate-to-severe Alzheimer’s over 6 months — and that the NNT may be in the single digits under some definitions (improvement or stabilization)

 

There is uncertainty in the NNT because “response” may mean different things (cognitive stabilization, slower decline, modest gains) in different studies. 

 

That causes NNT to vary: single-outcome responder analyses commonly yield NNT ≈ 6–10, while more conservative composite responder definitions (e.g., simultaneous improvement on multiple scales) can produce higher NNTs (≈20). (5,6)

 

 

How soon can Namzaric's effects start?

Donepezil (component of Namzaric) may begin to show measurable cognitive benefits in 1 to 3 months, and many patients begin to notice effects by about 4–6 weeks. (1)

 

Memantine’s effects (and hence Namzaric’s full benefit) are more gradual, with clinical trials typically using 24–28 week durations to demonstrate benefit over placebo. (7,8)

 

Therefore, for the combination (Namzaric), it is reasonable to expect that some benefit may appear within weeks to a few months, but full effects on cognition or daily functioning are most often assessed after several months of continuous therapy.

 

How long do effects last?

Benefits can be maintained long-term (years) with continuous therapy. Several sources suggest that cognitive and functional benefit from cholinesterase inhibitors (and by extension, potentially combination therapy) can persist over 1–2 years or longer when the medications are continued. (9, 10,11)

 

Stopping therapy may lead to decline. Abrupt discontinuation of cholinesterase inhibitors was associated with worse cognition and functional status over time. (12)

 

For therapies including Memantine (the other component of Namzaric), there is some data (from extension studies) showing that benefits remain stable over longer-term use. (13)

 

What is uncertain or not well established:

There is no clear, high-quality long-term RCT data definitively showing sustained benefit of the combination therapy (donepezil + memantine) over many years. Reviews note that, over long periods, it becomes difficult to distinguish drug effect from natural variability or slowing progression.

 

 

Number Needed to Harm (NNH)

The NNH, which estimates how many patients need to be treated before one experiences a significant adverse effect, varies depending on the side effect. Higher doses of donepezil (one component of Namzaric) are associated with greater risks of vomiting, syncope (fainting), and weight loss, but precise NNH values vary by study and side effect.

 

There are risks of adverse effects with long-term use (e.g., gastrointestinal side effects, weight loss, syncope), particularly in older or frail individuals — underscoring the need for regular monitoring; however, literature does not provide precise, universal NNH values for all side effects, because they vary by population, dose, and comorbidities.

 

Generally, serious adverse events are less common than benefits, but close monitoring is necessary.

 

 

Bottom line 

 

Namzaric offers modest cognitiveimprovement for a minority of patients with moderate to severe Alzheimer’s, helping slow decline and improve quality of life for several months with manageable side effects.

 

Continuous therapy with Namzaric may maintain benefits (cognition, daily functioning) for 1–2 years or longer in many patients.

 

Discontinuing therapy is associated — in some studies — with cognitive and functional decline over months to a year.

 

Families and caregivers should expect it may take several months of Namzaric treatment to observe improvement or slowing of symptoms.

 

Namzaric is taken once a day by mouth as a capsule, swallowed whole or opened and sprinkled on soft food if swallowing is difficult (but should not be crushed or chewed)

 

Side effects occur less frequently but can include gastrointestinal issues and fainting. Because long-term controlled data for combination therapy are limited, treatment response should ideally be assessed every 6–12 months (or earlier) to weigh ongoing benefits vs risks, especially in frail or older patients.

 

A careful balance of benefit to risk should be discussed with healthcare providers for individualized decision-making.

1. Deardorff, W. J., & Grossberg, G. T. (2016). A fixed-dose combination of memantine extended-release and donepezil in the treatment of moderate-to-severe Alzheimer’s disease. Drug Design, Development and Therapy, 10, 3267–3279. https://doi.org/10.2147/DDDT.S86463

2. Atri, A., Molinuevo, J. L., Lemming, O., Wirth, Y., Pulte, I., & Wilkinson, D., et al. (2013). Memantine in patients with Alzheimer’s disease receiving donepezil: new analyses of efficacy and safety for combination therapy. Alzheimer’s Research & Therapy, 5, Article 6. https://doi.org/10.1186/alzrt160 SpringerLink+1

3. Tariot, P. N., et al. (2004). Memantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil: a randomized controlled trial. Journal of the American Medical Association (JAMA), 291(3), 317-328. https://doi.org/10.1001/jama.291.3.317 PubMed+1

4. Schneider, L. S., Dagerman, K. S., Higgins, J. P. T., & McShane, R. (2011). Combined therapy with cholinesterase inhibitors and memantine for Alzheimer’s disease: a meta-analysis. Journal of Alzheimer’s Disease, 6(2), 147-155. 

5. Tampi, R. R., & van Dyck, C. H. (2007). Memantine: efficacy and safety in mild-to-severe Alzheimer’s disease. Neuropsychiatric Disease and Treatment, 3(2), 245–258. https://doi.org/10.2147/nedt.2007.3.2.245 (PMCID: PMC2654628)

6 . Seltzer, B., et al. (2004). Efficacy of donepezil in early-stage Alzheimer disease. JAMA Neurology, 61(3), 613–620. https://doi.org/10.1001/archneur.61.4.613

7. Grossberg, G. T., et al. (2018). Memantine ER maintains patient response in moderate to severe Alzheimer’s disease. Alzheimer’s Disease and Associated Disorders. https://doi.org/10.1097/WAD.0000000000000282

8. Reisberg, B., Doody, R., Stoffler, A., Schmitt, F., Ferris, S., & Möbius, H.-J. (2003). Memantine in moderate-to-severe Alzheimer’s disease. The New England Journal of Medicine, 348(14), 1333–1341.

9. Rogers, S. L., & Doody, R. S. (2003). Evidence for a long-term effect of cholinesterase inhibitors in Alzheimer’s disease. American Journal of Geriatric Psychiatry, 11(4), 475–482. https://doi.org/10.1176/appi.ajgp.11.4.475

10. Lundh, U., Almkvist, O., & Axelsson, A. (1996). Long-body stability of donepezil’s effect in Alzheimer’s disease patients: a 1-year open-label extension study. International Journal of Geriatric Psychiatry, 11(9), 761–769. https://doi.org/10.1002/(SICI)1099-1166(199609)11:9<761::AID-GPS572>3.0.CO;2-6

11. Howard, R., McShane, R., Lindesay, J., Ritchie, C., Baldwin, A., Barber, R., … Ballard, C. (2012). Long-term donepezil treatment in 565 patients with Alzheimer’s disease (AD2000): randomised double-blind trial. The BMJ, 344, e728. https://doi.org/10.1136/bmj.e728

12. Cochrane Dementia and Cognitive Improvement Group. (2021). Withdrawal or continuation of cholinesterase inhibitors or memantine or both, in people with dementia. Cochrane Database of Systematic Reviews, 2021(6), CD009081. https://doi.org/10.1002/14651858.CD009081.pub2

13. Winblad, B., Poritis, N. (1999). Memantine in severe dementia: results of the 24-week study extension. Dementia and Geriatric Cognitive Disorders, 10(3), 161–171. https://doi.org/10.1159/000017802