Clinical Trial: Nicotine Treatment of Mild Cognitive Impairment (MCI)
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Double-Blind Treatment of Mild Cognitive Impairment (MCI) With Transdermal Nicotine or Transdermal Placebo
Brief Summary: The purpose of this 12-month study is to determine whether nicotine, administered in the form of nicotine patches, can improve symptoms of memory loss in some people experiencing mild memory problems (referred to in this study as "mild cognitive impairment" or MCI).
Detailed Summary:
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 12 months and will be conducted at 3 clinical sites in the United States.
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. Nicotine imitates many of the actions of acetylcholine. By administering nicotine over a longer period of time to patients with MCI, this study could lead to a better understanding of whether nicotine can act to improve memory loss symptoms over the longer term and whether it can help delay the progression of memory loss symptoms. The amount of nicotine in each patch used in this study is the same level found in patches that are used in people who are trying to quit smoking.
This study will include up to twelve visits.
Sponsor: National Institute on Aging (NIA)
Current Primary Outcome: Safety of transdermal nicotine patch [ Time Frame: 13 months ]
Original Primary Outcome:
Current Secondary Outcome:
- Change in cognitive performance [ Time Frame: 13 months ]
- Change in global functioning [ Time Frame: 13 months ]
Original Secondary Outcome:
Information By: National Institute on Aging (NIA)
Dates:
Date Received: September 9, 2004
Date Started: September 2003
Date Completion: July 2008
Last Updated: January 7, 2008
Last Verified: January 2008
