Nicotine Treatment of Cognitive Decline in Down Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01778946|
Recruitment Status : Recruiting
First Posted : January 29, 2013
Last Update Posted : May 20, 2019
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.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome Mild Cognitive Impairment||Drug: Low Dose Nicotine (7mg) Drug: Moderate Dose Nicotine (14mg)||Phase 1 Phase 2|
Over 50% of adults with Down Syndrome (DS) develop Alzheimer's disease (AD) by the age of 60 (Nadel 2003), and life expectancy in DS is now 50-60 years. Thus, age-associated cognitive impairment and dementia in older adults with DS is an urgent public health concern. The investigators propose that nicotinic stimulation is a promising strategy to stabilize or improve cognitive functioning in adults with DS, possibly with additional neuroprotective effects. The investigators have extensive experience investigating the role of nicotinic receptors on human cognition and impairment. This application takes advantage of new insights into treating Mild Cognitive Impairment (MCI-the precursor condition to Alzheimer's Disease (AD) in typically developing individuals) with nicotine to propose an open label pilot study of transdermal nicotine in middle-aged non-smoking DS patients who show early cognitive and/or behavioral changes consistent with MCI/dementia.
The goal of this study is to establish preliminary evidence for safety, gain preliminary evidence as to whether nicotine enhances cognitive functioning in DS adults, and examine electrophysiological, biological, and behavioral correlates of nicotinic stimulation effects.
The investigators propose that positive results on cognitive or functional indices that would lead to a larger and longer double-blind trial to test more definitively whether nicotinic stimulation may be cognitively and/or functionally enhancing for DS patients. The knowledge gained from the translational aspects of this project will guide the development of potentially 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. This work also represents the first time that cutting-edge advances in treating MCI/AD in the general population are immediately and rigorously applied to those with DS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nicotinic Treatment of Age-Related Cognitive Decline in Down Syndrome: An Open Label Pilot Trial|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Low Dose Nicotine (7mg) Moderate Dose Nicotine (14mg)
All participants in study will begin with the 7mg patch, titrating from 2 hours/day to a full 16 hours/day over the course of the first 7 days (based on individual tolerance).
Day 7 - Day 28 of the study, participants will apply a new nicotine patch daily. Depending on tolerance, some participants may increase to the moderate dose (14mg) patch.
All participants will apply a new patch daily for a total of 28 days (1 month)
Drug: Low Dose Nicotine (7mg)
Drug: Moderate Dose Nicotine (14mg)
- Safety of Nicotine Intervention [ Time Frame: 1 Month ]Measure safety of administering nicotine daily in terms of number and severity of adverse events.
- Cognitive Improvement [ Time Frame: 1 Month ]Measure whether daily low-moderate dose transdermal nicotine can enhance cognitive function/performance (memory, learning, attention) in middle aged persons with Down Syndrome, identified as suffering from mild cognitive decline.
- Exploratory [ Time Frame: 1 Month ]
The investigators will measure daily low-moderate dose nicotine treatment's changes to
- electrophysiologic markers of cognitive status, and
- clinical, biological and cognitive effects of genes such as apolipoprotein E(APOE)/CYP2A6 and behavioral measures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778946
|Contact: Alexander C Conley, Ph.D.||email@example.com|
|Contact: Paul A Newhouse, M.D.||firstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt Psychiatric Hospital||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator: Paul A Newhouse, MD|
|Sub-Investigator: Elisabeth Dykens, PhD|
|Sub-Investigator: Alexandra S Key, PhD|
|Principal Investigator:||Paul A Newhouse, MD||Vanderbilt University Dept. of Psychiatry|
|Study Director:||Alexander C Conley, PhD||Vanderbilt University Medical Center Dept. of Psychiatry|