Clinical efficacy of aniracetam, either as monotherapy or combined with cholinesterase inhibitors, in patients with cognitive impairment: a comparative open study

CNS Neurosci Ther. 2012 Apr;18(4):302-12. doi: 10.1111/j.1755-5949.2010.00244.x. Epub 2011 Feb 26.


Introduction: Dementia constitutes an increasingly prevalent cognitive disorder with serious socioeconomic implications.

Aims: In the present study, we aimed to evaluate the efficacy of aniracetam, either as monotherapy or combined with cholinesterase inhibitors (ChEIs), in terms of several neuropsychological parameters, in a considerable number of patients with dementia.

Results: In our prospective, open-label study, we enrolled a total of 276 patients (mean age 71 ± 8 years, 95 males) with cognitive disorders. Our study population comprised four groups: no treatment group (n = 75), aniracetam monotherapy group (n = 58), ChEIs monotherapy group (n = 68), and group of combined treatment (n = 68). Patients were examined with validated neuropsychological tests at baseline, 3, 6, and 12 months of treatment. In patients treated with aniracetam, all studied parameters were adequately maintained at 6 and 12 months, while emotional state was significantly improved at 3 months. In patients treated with ChEIs, we observed a significant cognitive deterioration at 12 months. The comparison between aniracetam and ChEIs in patients with relatively mild dementia (15 ≤ MMSE ≤ 25) revealed a significantly better cognitive performance with aniracetam at 6 months and improved functionality at 3 months. Comparing aniracetam monotherapy with combined treatment in the same population, aniracetam performed better in the cognitive scale at 6 months, and displayed a notable tendency for enhanced mood at 12 months and improved functionality at 6 months.

Conclusions: Our findings indicate that aniracetam (a nootropic compound with glutamatergic activity and neuroprotective potential) is a promising option for patients with cognitive deficit of mild severity. It preserved all neuropsychological parameters for at least 12 months, and seemed to exert a favorable effect on emotional stability of demented patients.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cholinesterase Inhibitors / administration & dosage*
  • Cognition Disorders / drug therapy*
  • Cognition Disorders / psychology*
  • Cohort Studies
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Nootropic Agents / administration & dosage*
  • Prospective Studies
  • Pyrrolidinones / administration & dosage*
  • Treatment Outcome


  • Cholinesterase Inhibitors
  • Nootropic Agents
  • Pyrrolidinones
  • aniracetam