Trial Outcomes & Findings for Nicotine Treatment of Cognitive Decline in Down Syndrome (NCT NCT01778946)
NCT ID: NCT01778946
Last Updated: 2022-05-10
Results Overview
Maximum transdermal nicotine dosage able to be maintained stably by participants.
COMPLETED
PHASE1/PHASE2
7 participants
1 Month
2022-05-10
Participant Flow
Participant milestones
| Measure |
Nicotine
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)
Low Dose Nicotine (7mg)
Moderate Dose Nicotine (14mg)
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine Treatment of Cognitive Decline in Down Syndrome
Baseline characteristics by cohort
| Measure |
Nicotine
n=7 Participants
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)
Low Dose Nicotine (7mg)
Moderate Dose Nicotine (14mg)
|
|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
|
BMI
|
24.9 Kg/m^2
STANDARD_DEVIATION 3.6 • n=99 Participants
|
PRIMARY outcome
Timeframe: 1 MonthMaximum transdermal nicotine dosage able to be maintained stably by participants.
Outcome measures
| Measure |
Nicotine
n=4 Participants
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)
Low Dose Nicotine (7mg); Moderate Dose Nicotine (14mg)
|
|---|---|
|
Tolerability of Nicotine Intervention
7 mg
|
1 Participants
|
|
Tolerability of Nicotine Intervention
14 mg
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 time-points over the 6-week testing period: at baseline, day 14, day 28 (end of treatment), and 2-weeks post-treatment on day 42.Psychomotor speed was measured by the performance on the CANTAB simple reaction time task
Outcome measures
| Measure |
Nicotine
n=4 Participants
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)
Low Dose Nicotine (7mg); Moderate Dose Nicotine (14mg)
|
|---|---|
|
Cognitive Improvement - Simple Response Time
Baseline
|
760.08 ms
Standard Deviation 542.96
|
|
Cognitive Improvement - Simple Response Time
Day 14
|
737.13 ms
Standard Deviation 566.94
|
|
Cognitive Improvement - Simple Response Time
Day 28
|
695.52 ms
Standard Deviation 344.87
|
|
Cognitive Improvement - Simple Response Time
Day 42
|
772.79 ms
Standard Deviation 552.51
|
SECONDARY outcome
Timeframe: 4 time-points over the 6-week testing period: at baseline, day 14, day 28 (end of treatment), and 2-weeks post-treatment on day 42.The investigators will measure daily low-moderate dose nicotine treatment's changes to electrophysiological markers of memory performance using an incidental memory task. The incidental memory task consists of presenting participants with a series of 60 complex images, 50 of which are presented once, and 10 which are repeated 5 times each. The task measures the presence of the late positive potential (LPP), a positive deflection over the parietal cortex which is elevated for the repeated compared to the singly presented images. The presence of this potential is indicative of improved recognition memory.
Outcome measures
| Measure |
Nicotine
n=4 Participants
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)
Low Dose Nicotine (7mg); Moderate Dose Nicotine (14mg)
|
|---|---|
|
Exploratory - Event-Related Potentials
Baseline Repeated
|
7.95 µV
Standard Deviation 0.78
|
|
Exploratory - Event-Related Potentials
Day 14 Repeated
|
6.64 µV
Standard Deviation 5.44
|
|
Exploratory - Event-Related Potentials
Day 28 Repeated
|
6.64 µV
Standard Deviation 4.8
|
|
Exploratory - Event-Related Potentials
Day 42 Repeated
|
7.49 µV
Standard Deviation 3.1
|
|
Exploratory - Event-Related Potentials
Baseline Single
|
6.87 µV
Standard Deviation 2.03
|
|
Exploratory - Event-Related Potentials
Day 14 Single
|
6.76 µV
Standard Deviation 2.38
|
|
Exploratory - Event-Related Potentials
Day 28 Single
|
5.83 µV
Standard Deviation 3.3
|
|
Exploratory - Event-Related Potentials
Day 42 Single
|
5.09 µV
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: 4 time-points over the 6-week testing period: at baseline, day 14, day 28 (end of treatment), and 2-weeks post-treatment on day 42.Performance on the Conners' Continuous Performance Test, which is a measure of sustained attention. The main outcome measure was commission errors, which measures attention failures. The commission errors are calculated as T-scores. Higher T-scores indicate worse performance, lower T-scores indicate better performance. Average performance is a score of 50, with a standard deviation of 10.
Outcome measures
| Measure |
Nicotine
n=4 Participants
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)
Low Dose Nicotine (7mg); Moderate Dose Nicotine (14mg)
|
|---|---|
|
Cognitive Improvement - Continuous Performance Test
Baseline
|
47.82 T-score
Standard Deviation 11.46
|
|
Cognitive Improvement - Continuous Performance Test
Day 14
|
49.23 T-score
Standard Deviation 6.41
|
|
Cognitive Improvement - Continuous Performance Test
Day 28
|
43 T-score
Standard Deviation 7.41
|
|
Cognitive Improvement - Continuous Performance Test
Day 42
|
42.95 T-score
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 4 time-points over the 6-week testing period: at baseline, day 14, day 28 (end of treatment), and 2-weeks post-treatment on day 42.Episodic memory performance was assessed by the Buschke Selective Reminding Task. The main outcome metric of this test was the total words correctly recalled.
Outcome measures
| Measure |
Nicotine
n=4 Participants
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)
Low Dose Nicotine (7mg); Moderate Dose Nicotine (14mg)
|
|---|---|
|
Cognitive Improvement - Buschke Selective Reminding Task
Baseline
|
33.75 Words Correctly Recalled
Standard Deviation 24.42
|
|
Cognitive Improvement - Buschke Selective Reminding Task
Day 14
|
41.5 Words Correctly Recalled
Standard Deviation 30.97
|
|
Cognitive Improvement - Buschke Selective Reminding Task
Day 28
|
54.5 Words Correctly Recalled
Standard Deviation 33.89
|
|
Cognitive Improvement - Buschke Selective Reminding Task
Day 42
|
45.5 Words Correctly Recalled
Standard Deviation 32.72
|
SECONDARY outcome
Timeframe: 4 time-points over the 6-week testing period: at baseline, day 14, day 28 (end of treatment), and 2-weeks post-treatment on day 42.Arousal and vigilance were measured by the Critical Flicker Fusion task. The task used at perceptual performance on ascending and descending frequencies of the task.
Outcome measures
| Measure |
Nicotine
n=4 Participants
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)
Low Dose Nicotine (7mg); Moderate Dose Nicotine (14mg)
|
|---|---|
|
Cognitive Improvement - Critical Flicker Fusion Task
Baseline Descending Frequency
|
36.9 Hz
Standard Deviation 9.01
|
|
Cognitive Improvement - Critical Flicker Fusion Task
Day 14 Descending Frequency
|
31.3 Hz
Standard Deviation 4.23
|
|
Cognitive Improvement - Critical Flicker Fusion Task
Baseline Ascending Frequency
|
20.6 Hz
Standard Deviation 8.7
|
|
Cognitive Improvement - Critical Flicker Fusion Task
Day 14 Ascending Frequency
|
29.7 Hz
Standard Deviation 8.4
|
|
Cognitive Improvement - Critical Flicker Fusion Task
Day 28 Ascending Frequency
|
31.6 Hz
Standard Deviation 8.27
|
|
Cognitive Improvement - Critical Flicker Fusion Task
Day 42 Ascending Frequency
|
30 Hz
Standard Deviation 11.7
|
|
Cognitive Improvement - Critical Flicker Fusion Task
Day 28 Descending Frequency
|
26.3 Hz
Standard Deviation 6.51
|
|
Cognitive Improvement - Critical Flicker Fusion Task
Day 42 Descending Frequency
|
26.2 Hz
Standard Deviation 4.65
|
Adverse Events
Nicotine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine
n=7 participants at risk
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)
Low Dose Nicotine (7mg)
Moderate Dose Nicotine (14mg)
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 5 • 6-weeks
Adverse events collected through query of subjects about any new or worsening problems or side effects, conducted at each contact.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place