Trial Outcomes & Findings for Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients (NCT NCT01602198)
NCT ID: NCT01602198
Last Updated: 2017-02-28
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2017-02-28
Participant Flow
Participant milestones
| Measure |
Exelon Transdermal Patch
Exelon \[rivastigmine\] transdermal patch
Exelon \[rivastigmine\] transdermal patch: Exelon patch 1/day for six months
|
Placebo Transdermal Patch
Placebo transdermal patch
Placebo patch: Placebo patch 1/day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients
Baseline characteristics by cohort
| Measure |
Exelon Transdermal Patch
Exelon \[rivastigmine\] transdermal patch
Exelon \[rivastigmine\] transdermal patch: Exelon patch 1/day for six months
|
Placebo Transdermal Patch
n=1 Participants
Placebo transdermal patch
Placebo patch: Placebo patch 1/day for 6 months
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: Trial was terminated prematurely after enrollment of only 1 participant. Sample size is insufficient for BOLD response analysis.
Outcome measures
Outcome data not reported
Adverse Events
Exelon Transdermal Patch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Transdermal Patch
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exelon Transdermal Patch
Exelon \[rivastigmine\] transdermal patch
Exelon \[rivastigmine\] transdermal patch: Exelon patch 1/day for six months
|
Placebo Transdermal Patch
n=1 participants at risk
Placebo transdermal patch
Placebo patch: Placebo patch 1/day for 6 months
|
|---|---|---|
|
Cardiac disorders
High blood pressure
|
—
0/0 • Adverse events were collected during the study.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place