Trial · NCT04739423
A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodegenerative Disorders
NCT04739423, Phase 2, Completed, CuraSen Therapeutics, Inc.; results first posted 2024-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodegenerative Disorders. Trials, record NCT04739423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04739423
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodegenerative Disorders
- NCT number
- NCT04739423
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- CuraSen Therapeutics, Inc.
- Conditions
- Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease Dementia
- Interventions
- clenbuterol (CST-103), nadolol (CST-107), matching placebo
- First posted
- 2021-02-04
- Last updated
- 2024-12-02
- Results first posted
- 2024-12-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | Days 7 and 14 of each Treatment Period (Two 14-day periods) | Faces with six different basic emotions (happiness, fear, anger, disgust, sadness, surprise) are briefly displayed on a screen and participants are required to indicate the expression of the face via a button-press. Cohort A only. |
| Primary | Change From Baseline in Cognitive Fluctuations | Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods) | Dementia Cognitive Fluctuation Scale (DCFS). Number of participants with improvement relative to screening. Cohort B only. |
| Secondary | Change From Baseline in CANTAB Cognitive Assessments | Days 1, 7, 14 of each Treatment Period (Two 14-day periods) | The CANTAB cognitive assessments consists of a series of interrelated computerized tests of memory, attention, and executive function, administered via a touch sensitive screen. This includes the immediate and delayed Verbal Recognition Memory (VRM) recall and recognition tests that measure the ability to encode and subsequently retrieve verbal information. |
| Secondary | Digital Wearable Device (BioStamp) - Sleeping Heart Rate | Screening, Days 1-14 of each Treatment Period (Two 14-day periods) | A wireless device that measures physical activity and sleep while at home. |
| Secondary | Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) | Screening, Days 1-14 of each Treatment Period (Two 14-day periods) | A wireless device that measures physical activity and sleep while at home. |
| Secondary | Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD) | Screening, Days 1-14 of each Treatment Period (Two 14-day periods) | A wireless device that measures physical activity and sleep while at home. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | Days 7 and 14 of each Treatment Period (Two 14-day periods) | Full Analysis Set (FAS) - The FAS included all randomized study subjects who had taken at least one dose of blinded study drug in this crossover study. In accordance with the protocol this outcome measure was only applicable for Cohort A.~Data are presented by treatment for each patient population analyzed. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Cognitive Fluctuations | Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods) | All participants enrolled in Cohort B. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in CANTAB Cognitive Assessments | Days 1, 7, 14 of each Treatment Period (Two 14-day periods) | Full Analysis Set (FAS) - The FAS included all randomized study subjects who had taken at least one dose of blinded study drug.~Data are presented by treatment for each patient population analyzed. | Words | LEAST_SQUARES_MEAN |
| SECONDARY | Digital Wearable Device (BioStamp) - Sleeping Heart Rate | Screening, Days 1-14 of each Treatment Period (Two 14-day periods) | Per protocol, the BioStamp wearable device was used in a substudy that included only the clinical sites based in Australia and New Zealand. There were a total of 18 subjects in this substudy. However, only 9 subjects provided a dataset that could be analyzed for treatment effect (ie. that included baseline data and end of study period data). Data are presented by treatment for each patient population. | beats per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) | Screening, Days 1-14 of each Treatment Period (Two 14-day periods) | Per protocol, the BioStamp wearable device was used in a substudy that included only the clinical sites based in Australia and New Zealand. There were a total of 18 subjects in this substudy. However, only 9 subjects provided a dataset that could be analyzed for treatment effect (ie. that included baseline data and end of study period data). Data are presented by treatment for each patient population. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD) | Screening, Days 1-14 of each Treatment Period (Two 14-day periods) | Per protocol, the BioStamp wearable device was used in a substudy that included only the clinical sites based in Australia and New Zealand. There were a total of 18 subjects in this substudy. However, only 9 subjects provided a dataset that could be analyzed for treatment effect (ie. that included baseline data and end of study period data). Data are presented by treatment for each patient population. | RMSSD | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | PD - Placebo | Accuracy for happiness - Change from baseline to Day 14 | 8.1316 | Standard Error 2.5783 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | PD - Active | Accuracy for happiness - Change from baseline to Day 14 | 13.6138 | Standard Error 2.5462 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | MCI - Placebo | Accuracy for happiness - Change from baseline to Day 14 | 8.0168 | Standard Error 4.9441 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | MCI - Active | Accuracy for happiness - Change from baseline to Day 14 | 6.7407 | Standard Error 4.9441 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | PD - Placebo | Accuracy for sadness - Change from baseline to Day 14 | -6.9002 | Standard Error 1.7950 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | PD - Active | Accuracy for sadness - Change from baseline to Day 14 | -2.1048 | Standard Error 1.7749 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | MCI - Placebo | Accuracy for sadness - Change from baseline to Day 14 | -7.7744 | Standard Error 2.3576 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | MCI - Active | Accuracy for sadness - Change from baseline to Day 14 | -5.8789 | Standard Error 2.3576 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | PD - Placebo | Reaction time for anger - Change from baseline to Day 7 | -150.77 | Standard Error 78.70 | Percent change |
| Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT) | PD - Active | Reaction time for anger - Change from baseline to Day 7 | 16.52 | Standard Error 75.97 | Percent change |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PD Sequence 1 | 12 | |
| Overall Study | STARTED | PD Sequence 2 | 13 | |
| Overall Study | STARTED | MCI Sequence 1 | 6 | |
| Overall Study | STARTED | MCI Sequence 2 | 7 | |
| Overall Study | STARTED | PDD or DLB Sequence 1 | 1 | |
| Overall Study | STARTED | PDD or DLB Sequence 2 | 2 | |
| Overall Study | COMPLETED | PD Sequence 1 | 12 | |
| Overall Study | COMPLETED | PD Sequence 2 | 12 | |
| Overall Study | COMPLETED | MCI Sequence 1 | 5 | |
| Overall Study | COMPLETED | MCI Sequence 2 | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events450
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | PD - Placebo | 3 | 25 | |
| other | Headache | Nervous system disorders | PD - Active | 5 | 24 | |
| other | Headache | Nervous system disorders | MCI - Placebo | 0 | 12 | |
| other | Headache | Nervous system disorders | MCI - Active | 2 | 13 | |
| other | Headache | Nervous system disorders | PDD and DLB - Placebo | 0 | 3 | |
| other | Headache | Nervous system disorders | PDD and DLB - Active | 0 | 2 | |
| other | Tremor | Nervous system disorders | PD - Placebo | 0 | 25 | |
| other | Tremor | Nervous system disorders | PD - Active | 6 | 24 | |
| other | Tremor | Nervous system disorders | MCI - Placebo | 0 | 12 | |
| other | Tremor | Nervous system disorders | MCI - Active | 0 | 13 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PD - Placebo | 0 | 25 |
| Total, all-cause mortality | PD - Active | 0 | 24 |
| Total, all-cause mortality | MCI - Placebo | 0 | 12 |
| Total, all-cause mortality | MCI - Active | 0 | 13 |
| Total, all-cause mortality | PDD and DLB - Placebo | 0 | 3 |
| Total, all-cause mortality | PDD and DLB - Active | 0 | 2 |
| Total, other adverse events | PD - Placebo | 16 | 25 |
| Total, other adverse events | PD - Active | 20 | 24 |
| Total, other adverse events | MCI - Placebo | 4 | 12 |
| Total, other adverse events | MCI - Active | 7 | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04739423
GET https://conductscience.org/api/trials/v1/NCT04739423/results?page=2