Trial Outcomes & Findings for Cholinergic Health After Menopause (CHAMP) (NCT NCT04129060)
NCT ID: NCT04129060
Last Updated: 2026-06-12
Results Overview
BOLD fMRI signal will be measured while each subject performs the N-back test. The Nback test is a measure of working memory where subjects see letters appear on the computer screen one at a time and they have to indicate whether a letter on the screen matches according to a rule which they are informed of and the rules change every nine letters. The condition with no working memory load is called the match condition and subjects indicate whether the current letter matches a target letter. For the working memory load conditions, the matching letter is either one, two, or three back in the sequence. We analyzed BOLD signal from the match condition and the two back conditions only. We examined BOLD signal from two regions involved in working memory, the dorsolateral prefrontal cortex and the posterior parietal cortex. Larger BOLD signal values indicate more blood flow to a particular part of the brain and this is interpreted as that brain region is involved in the task.
COMPLETED
EARLY_PHASE1
98 participants
Two hours post drug administration
2026-06-12
Participant Flow
Subjects were recruited through electronic and paper media in the Burlington, VT and Nashville, TN areas. Subjects were required to be one year since their last menstrual period, have no contraindications for MRI, be a nonsmoker, and be medically healthy.
After screening, subjects were randomized to the study days that included the drug mecamylamine or placebo.
Participant milestones
| Measure |
Mecamylamine Challenge
Subjects received mecamylamine on this study day according to the randomization schedule.
|
Placebo Challenge
Subjects received mecamylamine or placebo according to the randomization schedule. Subjects in this group were randomized to receive placebo first and mecamylamine second.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
53
|
|
Overall Study
COMPLETED
|
40
|
50
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Mecamylamine Challenge
Subjects received mecamylamine on this study day according to the randomization schedule.
|
Placebo Challenge
Subjects received mecamylamine or placebo according to the randomization schedule. Subjects in this group were randomized to receive placebo first and mecamylamine second.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
Baseline Characteristics
Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
Baseline characteristics by cohort
| Measure |
Mecamylamine Challenge
n=45 Participants
Subjects received mecamylamine or placebo according to the randomization schedule. Subjects in this group were randomized to receive mecamylamine first and placebo second.
|
Placebo Challenge
n=53 Participants
Subjects received mecamylamine or placebo according to the randomization schedule. Subjects in this group were randomized to receive placebo first and mecamylamine second in this group.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=27 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=267 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
|
Age, Continuous
|
60.41 years
STANDARD_DEVIATION 4.79 • n=9 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
58.44 years
STANDARD_DEVIATION 5.09 • n=27 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
59.35 years
STANDARD_DEVIATION 5.03 • n=267 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
|
Sex: Female, Male
Female
|
45 Participants
n=9 Participants • Eight of these subjects withdrew consent and did not complete the study procedures.
|
53 Participants
n=27 Participants • Eight of these subjects withdrew consent and did not complete the study procedures.
|
98 Participants
n=267 Participants • Eight of these subjects withdrew consent and did not complete the study procedures.
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants • Eight of these subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=27 Participants • Eight of these subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=267 Participants • Eight of these subjects withdrew consent and did not complete the study procedures.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=27 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=267 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=27 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=267 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=27 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=267 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
4 Participants
n=27 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
5 Participants
n=267 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
|
Race (NIH/OMB)
White
|
44 Participants
n=9 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
49 Participants
n=27 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
93 Participants
n=267 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=27 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
0 Participants
n=267 Participants • Eight of the enrolled subjects withdrew consent and did not complete the study procedures.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
0 Participants
n=27 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
1 Participants
n=267 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=9 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
53 Participants
n=27 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
97 Participants
n=267 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
0 Participants
n=27 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
0 Participants
n=267 Participants • Eight subjects decided to withdraw consent and discontinue participation before completing the study procedures.
|
PRIMARY outcome
Timeframe: Two hours post drug administrationPopulation: The drug mecamylamine became unavailable towards the end of our five year study and not all enrolled subjects could participate in the drug challenge days. Every subject received mecamylamine and placebo according to a randomization schedule.
BOLD fMRI signal will be measured while each subject performs the N-back test. The Nback test is a measure of working memory where subjects see letters appear on the computer screen one at a time and they have to indicate whether a letter on the screen matches according to a rule which they are informed of and the rules change every nine letters. The condition with no working memory load is called the match condition and subjects indicate whether the current letter matches a target letter. For the working memory load conditions, the matching letter is either one, two, or three back in the sequence. We analyzed BOLD signal from the match condition and the two back conditions only. We examined BOLD signal from two regions involved in working memory, the dorsolateral prefrontal cortex and the posterior parietal cortex. Larger BOLD signal values indicate more blood flow to a particular part of the brain and this is interpreted as that brain region is involved in the task.
Outcome measures
| Measure |
Mecamylamine Challenge
n=77 Participants
One of the two study days will be the oral mecamylamine.
|
Placebo Challenge
n=77 Participants
One of the two study days will be the oral placebo.
|
|---|---|---|
|
Blood Oxygen Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI)
Dorsolateral Prefrontal Cortex
|
0.0472 Arbitrary units (a.u.)
Standard Deviation 0.061
|
0.0753 Arbitrary units (a.u.)
Standard Deviation 0.061
|
|
Blood Oxygen Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI)
Posterior Parietal Cortex
|
0.060 Arbitrary units (a.u.)
Standard Deviation 0.069
|
0.078 Arbitrary units (a.u.)
Standard Deviation 0.009
|
PRIMARY outcome
Timeframe: Two hours post drug administrationPopulation: The drug mecamylamine became unavailable towards the end of our five year study and not all enrolled subjects could participate in the drug challenge days. Every subject received mecamylamine and placebo according to a randomization schedule. The number of subjects completing this outcome measure is different than the BOLD and Volume measures because these measures did not rely on a successful MRI scan as the other measures did. Thus, there are more subjects who completed this computerized task.
We assessed working memory performance on the N-back test. During the Nback where subjects see letters appear on the computer screen one at a time and they have to press a button to indicate whether a letter on the screen matches according to a rule. The are informed of the rule and the rules change every nine letters. The condition with no working memory load is called the match condition and subjects indicate whether the current letter matches a target letter. For the working memory load conditions, the matching letter is either one, two, or three back in the sequence. We examined performance using an accuracy measure called d' (d prime) across the 0 back and 2 back conditions similar to the BOLD analysis. Larger d' indicates better memory performance.
Outcome measures
| Measure |
Mecamylamine Challenge
n=84 Participants
One of the two study days will be the oral mecamylamine.
|
Placebo Challenge
n=84 Participants
One of the two study days will be the oral placebo.
|
|---|---|---|
|
Working Memory Performance
0 back
|
2.27 d' (d prime)
Standard Deviation 1.46
|
2.61 d' (d prime)
Standard Deviation 1.17
|
|
Working Memory Performance
2 back
|
1.39 d' (d prime)
Standard Deviation 1.05
|
1.33 d' (d prime)
Standard Deviation 0.93
|
PRIMARY outcome
Timeframe: assessed during the MRIsPopulation: The drug mecamylamine became unavailable towards the end of our five year study and not all enrolled subjects could participate in the drug challenge days. Every subject received mecamylamine and placebo according to a randomization schedule.
Volumes of the right and left BFCS are reported and these measures were acquired during the MRI on each study day.
Outcome measures
| Measure |
Mecamylamine Challenge
n=77 Participants
One of the two study days will be the oral mecamylamine.
|
Placebo Challenge
n=77 Participants
One of the two study days will be the oral placebo.
|
|---|---|---|
|
Volume of Basal Forebrain Cholinergic System (BFCS)
Right BFCS
|
309.08 cubic mm (mm3)
Standard Deviation 35.41
|
310.32 cubic mm (mm3)
Standard Deviation 34.20
|
|
Volume of Basal Forebrain Cholinergic System (BFCS)
Left BFCS
|
280.30 cubic mm (mm3)
Standard Deviation 34.13
|
283.04 cubic mm (mm3)
Standard Deviation 33.07
|
Adverse Events
Mecamylamine Challenge
Placebo Challenge
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place