What is Mild Cognitive Impairment (MCI)?
Mild cognitive impairment causes cognitive changes that are serious enough to be noticed by the individuals experiencing them or to other people, but the changes are not severe enough to interfere with daily life or independent function.
What is the Purpose of the Study?
The purpose of this study is to determine whether nicotine can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as “mild cognitive impairment” or MCI). The study will last approximately two years (24 months) and will be conducted at 20-30 clinical sites in the United States. Each site will enroll 10-15 subjects, for a total of 300 subjects throughout all of the sites. Participants will be assigned to one of 2 treatment groups: nicotine or placebo.
Recent studies have suggested that one of the causes of memory disorders may be a reduction in a particular chemical substance in the brain. This chemical substance, acetylcholine, is thought to act on certain brain cells in a specific way that helps us to remember and use memories as well as affect our mood. In MCI (and Alzheimer’s disease), the level of acetylcholine may be changed, and this may impair brain functioning. Preliminary studies have suggested that short-term administration of nicotine appears to improve memory in patients with mild memory loss and early Alzheimer’s disease. It has been known for many years that nicotine imitates many of the actions of acetylcholine. By administering nicotine over a longer period of time to patients with MCI, we hope to better understand whether nicotine may act to improve memory loss symptoms over the longer term and whether it may help to delay the progression of memory loss symptoms.