At a glance
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Nicotinic Treatment of Age-Related Cognitive Decline in Down Syndrome: An Open Label Pilot Trial
In Brief
A Phase 2 clinical trial evaluating Low Dose Nicotine (7mg) and Moderate Dose Nicotine (14mg) for Down Syndrome and Mild Cognitive Impairment. Completed, enrolled 7 participants across 1 site.
Detailed Summary
This study will ascertain whether nicotine is safe and tolerable in DS patients, help with dose-ranging of nicotine in DS, look for evidence of enhancements in cognitive functioning, and establish evidence for biological and behavioral correlates of nicotinic stimulation effects. The knowledge gained from the translational aspects of this project may also guide the application of new nicotinic drugs in DS and generate, for the first time, data on the importance of nicotinic receptor changes in the development of cognitive impairment in DS adults. Hypotheses: * Transdermal nicotine treatment will be well tolerated out to one month by non-smoking DS patients without significant adverse effects. * Nicotine will enhance cognitive performance by one month compared to baseline and post-treatment testing. * Nicotine will enhance functioning detectable by clinician and/or informant ratings (pre-post).