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Eptastigmine led to cognitive, clinical, and functional benefits in Alzheimer's disease

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Question In patients with moderate to moderately severe Alzheimer's disease (AD), how effective and safe is eptastigmine?

Design

Randomised, double blind, placebo controlled trial with 24 weeks of follow up.

Setting

36 centres in the US and Europe.

Patients

491 patients (mean age 71 y, 63% women) who met the diagnostic criteria for AD established by the NINCDS-ADRDA and described by DSM-IV, and who had a cognitive deficit for ≥6 months, a Mini-Mental State Examination Scale score between 10 and 22, a Global Deterioration Scale rating of 4 or 5, a modified Hachinski ischaemic score <3, and a Hamilton Depression Scale score <18. Exclusion criteria were other neurological or psychiatric disorders; renal, hepatic, or cardiovascular diseases; peptic ulcer; bronchial asthma; neutropenia; deficiencies in thyroxine, vitamin B12, or folate; or treatment with medication known to affect the central nervous system. 86% completed the study.

Intervention

164 patients were assigned to placebo, 166 to 15 mg 3 times daily of eptastigmine, and 161 to 20 mg 3 times daily of eptastigmine for a period of 24 weeks. Eptastigmine was given using a 4 week stepwise dose escalation starting from 5 …

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