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Kolykhalov I.V.

Mental Health Research Center

Mkhitaryan E.A.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Fedorova Y.B.

Research Center for Mental Health

Ponomareva E.V.

Research Center for Mental Health

Selezneva N.D.

Mental Health Research Center

Cherdak M.A.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Dudchenko N.G.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Seyfedinova A.B.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Isaev R.I.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Gavrilova S.I.

Mental Health Research Centre

Tkacheva O.N.

Pirogov Russian National Research Medical University

Russian experience in using a combination of fixed doses of donepezil and memantine in the treatment of Alzheimer’s disease as an observational non-interventional multicenter program

Authors:

Kolykhalov I.V., Mkhitaryan E.A., Fedorova Y.B., Ponomareva E.V., Selezneva N.D., Cherdak M.A., Dudchenko N.G., Seyfedinova A.B., Isaev R.I., Gavrilova S.I., Tkacheva O.N.

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Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(12): 69‑75

DOI: 10.17116/jnevro202312312169

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To cite this article:

Kolykhalov IV, Mkhitaryan EA, Fedorova YB, et al. . Russian experience in using a combination of fixed doses of donepezil and memantine in the treatment of Alzheimer’s disease as an observational non-interventional multicenter program. S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(12):69‑75. (In Russ.)
https://doi.org/10.17116/jnevro202312312169

Подписка 2025 (S.S. Korsakov Journal of Neurology and Psychiatry)
 
 
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OBJECTIVE

To evaluate the efficacy, safety, and compliance to therapy with Mioreol, first used as part of routine clinical practice in patients with moderate-to-severe dementia due to AD.

MATERIAL AND METHODS

The study was conducted as a non-interventional observational program. The work was performed on a group of 48 patients with moderate-to-severe AD aged from 60 to 90 years (median age 74 [69; 77]). The therapeutic dose of Mioreol was 10 mg donepezil + 20 mg memantine, the drug was taken orally, once a day at the same time, regardless of meals. The duration of the course of therapy was 24 weeks. The effects of the drug were assessed using the MMSE, ADAS-Cog, NPI, and CGI scales before the start of therapy and by the end of 12 and 24 weeks of treatment.

RESULTS

The use of Mioreol in six-month therapy of AD patients with moderate-to-severe dementia improved not only cognitive but also a wide range of non-cognitive mental disorders. There was an improvement in the CGI-C scale in more than 50% of included patients, positive dynamics on the ADAS-cog scale (6.5 points reduction in total score) and reduction of non-cognitive mental disorders on the NPI scale (4 points reduction in total score).

CONCLUSION

Fixed-dose combination therapy with Mioreol is an effective and well-tolerated treatment option for patients with moderate-to-severe AD. A combination of fixed-dose therapeutic doses of donepezil and memantine is potentially more appropriate than the simultaneous use of two recommended drugs for the treatment of AD, which will improve treatment adherence in patients with moderate to severe AD.

Keywords:

Alzheimer’s disease
cholinesterase inhibitor
donepezil
fixed-dose combination
memantine
Mioreol

Authors:

Kolykhalov I.V.

Mental Health Research Center

Mkhitaryan E.A.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Fedorova Y.B.

Research Center for Mental Health

Ponomareva E.V.

Research Center for Mental Health

Selezneva N.D.

Mental Health Research Center

Cherdak M.A.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Dudchenko N.G.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Seyfedinova A.B.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Isaev R.I.

Russian Gerontological Scientific and Clinical Center separate structural department of N.I. Pirogov Russian National Research Medical University

Gavrilova S.I.

Mental Health Research Centre

Tkacheva O.N.

Pirogov Russian National Research Medical University

Received:

30.11.2023

Accepted:

01.12.2023

List of references:

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  2. Shirbhate E, Patel VK, Tiwari P, et al. Combination Therapy for the Treatment of Alzheimer’s Disease: Recent Progress and Future Prospects. Curr Top Med Chem. 2022;22(22):1849-1867. https://doi.org/10.2174/1568026622666220907114443
  3. Lee JH, Jeong SK, Kim BC, et al. Donepezil across the spectrum of Alzheimer’s disease: dose optimization and clinical relevance. Acta Neurol Scand. 2015;131(5):259-267.  https://doi.org/10.1111/ane.12386
  4. Deardorff WJ, Grossberg GT. Pharmacotherapeutic strategies in the treatment of severe Alzheimer’s disease. Expert Opin Pharmacother. 2016;17(13):1789-1800. https://doi.org/10.1080/14656566.2016.1215431
  5. Gauthier S, Molinuevo JL. Benefits of combined cholinesterase inhibitor and memantine treatment in moderate-severe Alzheimer’s disease. Alzheimers Dement. 2013;9(3):326-331.  https://doi.org/10.1016/j.jalz.2011.11.005
  6. Calhoun A, King C, Khoury R, Grossberg GT. An evaluation of memantine ER + donepezil for the treatment of Alzheimer’s disease. Expert Opin Pharmacother. 2018;19(15):1711-1717. https://doi.org/10.1080/14656566.2018.1519022
  7. Guo J, Wang Z, Liu R, et al. Memantine, Donepezil, or Combination Therapy-What is the best therapy for Alzheimer’s Disease? A Network Meta-Analysis. Brain Behav. 2020;10(11):e01831. https://doi.org/10.1002/brb3.1831
  8. Singh G, Thomas SK, Arcona S, et al. Treatment persistency with rivastigmine and donepezil in a large state medicaid program. J Am Geriatr Soc. 2005;53(7):1269-1270. https://doi.org/10.1111/j.1532-5415.2005.53384_9.x
  9. Bangalore S, Kamalakkannan G, Parkar S, Messerli FH. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med. 2007;120(8):713-719.  https://doi.org/10.1016/j.amjmed.2006.08.033
  10. Deardorff WJ, Grossberg GT. A fixed-dose combination of memantine extended-release and donepezil in the treatment of moderate-to-severe Alzheimer’s disease. Drug Des Devel Ther. 2016;10:3267-3279. https://doi.org/10.2147/DDDT.S86463
  11. Touchon J, Lachaine J, Beauchemin C, et al. The impact of memantine in combination with acetylcholinesterase inhibitors on admission of patients with Alzheimer’s disease to nursing homes: cost-effectiveness analysis in France. Eur J Health Econ. 2014;15(8):791-800.  https://doi.org/10.1007/s10198-013-0523-y
  12. Dou KX, Tan MS, Tan CC, et al. Comparative safety and effectiveness of cholinesterase inhibitors and memantine for Alzheimer’s disease: a network meta-analysis of 41 randomized controlled trials. Alzheimers Res Ther. 2018;10(1):126.  https://doi.org/10.1186/s13195-018-0457-9
  13. Chen R, Chan PT, Chu H, et al. Treatment effects between monotherapy of donepezil versus combination with memantine for Alzheimer disease: A meta‐analysis. PLoS One. 2017;12(8);e183586. https://doi.org/10.1371/journal.pone.0183586
  14. Smolyarchuk EA, Leykin ZN. Comparative clinical study of the pharmacokinetics and bioequivalence of the combined drug Mioreol and the combined use of mono-drugs containing donepezil and memantine. Zhurnal Nevrologii i Psikhiatrii im. S.S. Korsakova. 2022;122(3):85-91. (In Russ.). https://doi.org/10.17116/jnevro202212203185
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