Nicotine Treatment of Cognitive Decline in Down Syndrome
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Vanderbilt University Vanderbilt University Medical Center