By Jenny Powers
THESSALONIKI, Greece -- March 16, 2010 -- Aniracetam as monotherapy is effective in preserving cognitive function at 1 year of treatment, according to study results presented here at the 25th Conference of Alzheimer's Disease International (ADI).
Chrysie Koliaki, MD, 2nd Propaedeutic Department of Internal Medicine, Research Institute and Diabetes Center, Attikon University Hospital, Medical School of Athens, Athens, Greece, presented the results of this prospective, multicentre, open-label study on March 11.
The study aimed to evaluate the efficacy of aniracetam, which selectively modulates the alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor, both as monotherapy and in combination with cholinesterase inhibitors, as determined by cognitive, functional, and behavioural parameters in patients with dementia.
The study enrolled 252 patients with cognitive disorders of variable severity; 25 patients had mild cognitive impairment, 192 were diagnosed with Alzheimer's disease (AD), and 35 had other forms of dementia. The study had 4 treatment groups: no treatment (n = 75), aniracetam monotherapy group (n = 47), cholinesterase inhibitor monotherapy (n = 68), and combination treatment (n = 62). Patients were examined with validated neuropsychological tests at baseline and at 3, 6, and 12 months.
Patients in the no-treatment group declined significantly in cognitive performance at 12 months (P = .004). Aniracetam-treated patients remained stable in all evaluated parameters at 6 and 12 months and showed improved emotional status beginning at 3 months (P = .03). A statistically significant deterioration of cognitive status was observed at 12 months in the patients treated with cholinesterase inhibitors (P = .01), whereas patients in the combination-treatment group demonstrated improved emotional status at 3 months (P = .04), followed by a decline of mental (P = .04) and functional (P = .05) parameters at 12 months.
In a subgroup analysis, patients with moderate dementia (Mini-Mental State Examination [MMSE] 15-25) displayed significantly better cognitive performance with aniracetam monotherapy at 6 months of treatment than with cholinesterase inhibitor monotherapy, respectively (MMSE 23.4 +- 3.1 vs 18.7 +- 4.2; P = .005). Patients with moderate dementia treated only with aniracetam performed better than those who received combination therapy on cognitive (P = .002) and functional scales (P = .05) at 6 months, and their mood was significantly improved at 12 months (P = .03).
The researchers concluded that aniracetam holds promise for the long-term treatment of patients with Alzheimer's disease who have moderate cognitive defect. Aniracetam monotherapy was superior to combination therapy and cholinesterase inhibitor monotherapy in preserving neuropsychological parameters for at least 12 months and had a favourable effect on the emotional state of patients with Alzheimer's disease.
[Presentation title: The Effect of Aniracetam, Either as Monotherapy or Combined With Cholinesterase Inhibitors, on Neuropsychological Findings of Patients With Dementia in Different Stages. Data From the Greek Amnesia Study: Aniracetam Monotherapy Compared With Cholinesterase Inhibitors. Abstract OC055]
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