[Oestro-progestagen treatment combined with rivastigmine in menopausal women suffering from Alzheimer's disease. The results of a 28-weeks controlled study]

Abstract

Objective: To compare the efficacy on cognitive function of the combination of hormone replacement therapy with rivastigmine, acetylcholinesterase inhibitor, in menopausal women suffering from mild to moderately severe Alzheimer's disease.

Method: This was a randomised double blind study of 117 women suffering from mild to moderately severe Alzheimer-like dementia (MMSE between 10 and 26). The patients were randomly assigned to continuous hormone therapy (n=59) and placebo (n=58), all receiving treatment with rivastigmine. Follow-up was of 28 weeks. ASSESSMENT CRITERIA: ADAS-Cog (Alzheimer's disease assessment scale--cognitive subscale) (primary endpoint); MMSE (mini mental state examination), GDS (global deterioration scale), CGC-Plus (clinical global change-plus), NPI (neuropsychiatric inventory), IADL (instrumental activities of daily living). Data regarding tolerance was recorded.

Results: No significant difference was observed in the parameters assessing efficacy (cognitive function, global assessment, functioning, neuropsychiatric symptoms) and tolerance between the two groups of treatment.

Conclusion: Oestro-progestagen treatment did not provide further improvement when combined with rivastigmine during mild to moderately severe Alzheimer's disease.