Nicotine Treatment of Cognitive Decline in Down Syndrome (NCT01778946) | Clinical Trial Compass
CompletedPhase 1/2
Nicotine Treatment of Cognitive Decline in Down Syndrome
United States7 participantsStarted 2013-04
Plain-language 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).
Who can participate
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Cognitive complaints and/or memory difficulties which are verified as new onset by an informant.
* Cognitive Global Rating consistent with mild impairment or deterioration from premorbid baseline.
* General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease/dementia cannot be made by the physician at the time of the screening visit.
* No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4.
* Age 25+.
* Stable medications for at least 1 month prior to screening. Central nervous system (CNS) medications should be stable for 3 months.
* No evidence of major depression.
* Informant is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more).
* Adequate visual and auditory acuity to allow neuropsychological testing.
* Good general health with no additional diseases expected to interfere with the study.
* Normal B12, rapid plasma reagin (RPR), and Thyroid Function Tests or without any clinically significant abnormalities that would be expected to interfere with the study.
* ECG without clinically significant abnormalities that would be expected to interfere with the study.
* Subject is not pregnant, lactating.
* Subjects will be taking no drugs with cholinergic properties (e.g donepezil).
* Agreement not to take other vitamin or supplements other than multivitamins.
* Negative urine pregnancy test in females.
Exclusion Criteria…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.