Cliinnical trials about anti–Alzheimer's disease effects of Melissa officinalis extract

Abstract

Previous basic studies on Alzheimer's disease (AD) models have reported that rosmarinic acid (RA) can inhibit the aggregation including oligomerization of amyloid β–protein (Aβ) resulting in the decrease of cyto– and synaptic toxicities. We conducted the randomized placebo–controlled double–blind trials aimed to assess i) pharmacokinetics, ii) safety and tolerability, and iii) efficacy of lemon balm (Melissa officinalis : M. officinalis) extract containing RA on cognition in older adults without dementia. We conducted three randomized placebo–controlled double–blind trials ; the first one was performed in healthy individuals (n = 11) to assess the tolerability and safety of M. officinalis extract capsule, the second one aimed to show the safety, tolerability, and efficacy in patients with mild AD dementia (n = 20), and the third one investigated the effects on cognition in older adults (n = 323) without dementia. The results indicate that M. officinalis extract is tolerable and safe in healthy individuals and patients with mild AD dementia. Additionally, M. officinalis may prevent cognitive decline in older adults without hypertension.