CLIN-011

CompletedPhase 2Results posted

A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodegenerative Disorders

A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover, Study of the Pharmacodynamic Effects of CST-103 Co-administered With CST-107 on the Central Nervous System in Subjects With Neurodegenerative Disorders

Lead sponsor

CuraSen Therapeutics, Inc.

Asset

Clenbuterol / nadolol

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MoCA 18-28•Study partner/caregiver required

Primary endpoints

•Negative Emotional Bias in the Facial Expression Recognition Task (FERT)•Cognitive Fluctuations

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCST103/CST107-CLIN-011

NCT IDNCT04739423

Timeline

Milestones

Study first posted2021-02-04actual

Study start2021-06-28actual

Primary completion2022-07-04actual

Study completion2022-08-31actual

Last update posted2024-12-02actual

Results first posted2024-12-02actual

Assets

Drug assets

Clenbuterol / nadolol

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age40 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Subjects with PD:

•Male or female subjects ≥ 40 and ≤ 80 years of age, at time of informed consent.

•Diagnosed with Parkinson's Disease, as defined by the United Kingdom Parkinson Disease Brain Bank criteria, associated with REM sleep behavior disorder (PD)

•Modified Hoehn \& Yahr ≥ stage 1 and ≤ stage 3 during "On" period as documented in the 3 months prior to Screening or completed at Screening.

•Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 28.

Subjects with MCI:

•Male or female subjects ≥ 50 and ≤ 80 years of age, at time of informed consent.

•Meet the criteria for amnestic Mild Cognitive Impairment (MCI) as per the National Institute on Aging-Alzheimer's Association core clinical criteria.

•Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 26.

•No dementia according to the International Classifications of Diseases (ICD)-10 and Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV.

•Memory complaint reported by the subject or his/her partner, family member or caregiver.

•Score of greater than or equal to one standard deviation below age and educational norms in the Digit Symbol Substitution Test (DSST) during Screening.

•Cognitive decline not primarily caused by vascular, traumatic, or medical problems.

Subjects with Dementia with Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD):

•Male or female subjects ≥ 50 and ≤ 80 years of age, at time of informed consent.

•Diagnosis of dementia associated with Dementia with Lewy Bodies or Parkinson's disease (PDD).

•Documented cognitive fluctuations endorsed on the Dementia Cognitive Fluctuation Scale (DCFS) with a combined score of ≥8 in items 4, 11, 12 and 14.

•Montreal Cognitive Assessment (MoCA) score ≥ 18 and ≤ 26.

•Have informant or caregiver throughout the study who will submit written consent to cooperate with this study, who routinely accompanies and/or stays with subject 12 hours or more a week, assists with treatment compliance, provides assessments and is able to escort the subject on required visits to study institution.

•Modified Hoehn \& Yahr ≥ stage 1 and ≤ stage 3 during "On" period as documented in the 3 months prior to Screening or completed at Screening.

•Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI.

For ALL Subjects:

•Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.

•Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from start of Screening through 30 days after the last study medication administration: use a reliable method of birth control, or monogamous relationship with a male partner of confirmed sterility, or practice complete abstinence.

•Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal.

•Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg/m2, inclusive at Screening.

•Stable medical conditions for 3 months prior to Screening visit (e.g., controlled hypertension, dyslipidemia).

•Willing to follow the protocol requirements and comply with protocol restrictions.

•Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative

Exclusion criteria

•Poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.

•Pulmonary disease, including asthma if requiring the use of a β2-Adrenergic bronchodilator, or evidence of clinically significant moderate or severe pulmonary symptoms.

•Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, or Babinski sign.

•Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or meeting DSM-IV diagnostic criteria for psychotic disorders.

•Evidence of any significant clinical disorder or laboratory finding (or in the case of potassium levels below normal range) that renders the participant unsuitable for receiving an investigational drug.

•History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).

•Any clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments conducted at Screening.

•Clinically significant abnormalities of ECG, including QTcF > 450 ms, for males and QTcF > 470 ms for females, and/or HR < 50 beats per minute, or evidence of clinically significant bundle branch blocks, as indicated by 12-lead ECG.

•Calculated creatinine clearance of ≤70 mL/min according to the Cockcroft-Gault equation.

•Current use of any prohibited prescription medication (high-dose aspirin, paracetamol or levodopa, β-AR agonists or β-AR blockers, hypnotics or benzodiazepines other than clonazepam, monoamine oxidase inhibitors, opioids ), over-the-counter medication, or herbal supplements/products.

•Prior treatment with any investigational drug ≤90 days prior to dosing (Day 1), or ≤5 half-lives of the drug (whichever is longer), or current enrollment in any other study treatment or disease study, except for observational studies.

•Known or suspected alcohol or substance abuse within the past 12 months and/or positive test for alcohol or drugs of abuse.

•Active suicidal ideation within 3 months prior to study Screening.

•Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] at Screening).

•Positive screening test for human immunodeficiency virus (HIV).

•Current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

•Contraindications to wearing the BioStamp digital device sensors, which include but are not limited to implanted pacemakers, defibrillators, or other active implantable devices.

•Known allergies or hypersensitivities to adhesives or hydrogel.

•Other reasons for which the PI considers it is not in the best interest of the participant to undertake the study.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Memory

Other (unclassified)

Memory

4 endpoints

Primary/protocol endpoint

Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)

Time frame:Days 7 and 14 of each Treatment Period (Two 14-day periods)

change from baseline, improvement

Primary/registry result

Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)

Time frame:Days 7 and 14 of each Treatment Period (Two 14-day periods)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	Standard error
PD - PlaceboAccuracy for happiness - Change from baseline to Day 14n=23 Participants	8.1316	2.5783
Accuracy for sadness - Change from baseline to Day 14n=23 Participants	-6.9002	1.7950
Reaction time for anger - Change from baseline to Day 7n=21 Participants	-150.77	78.70
PD - ActiveAccuracy for happiness - Change from baseline to Day 14n=24 Participants	13.6138	2.5462
Accuracy for sadness - Change from baseline to Day 14n=24 Participants	-2.1048	1.7749
Reaction time for anger - Change from baseline to Day 7n=23 Participants	16.52	75.97
MCI - PlaceboAccuracy for happiness - Change from baseline to Day 14n=12 Participants	8.0168	4.9441
Accuracy for sadness - Change from baseline to Day 14n=12 Participants	-7.7744	2.3576
Reaction time for anger - Change from baseline to Day 7n=12 Participants	-17.51	158.55
MCI - ActiveAccuracy for happiness - Change from baseline to Day 14n=12 Participants	6.7407	4.9441
Accuracy for sadness - Change from baseline to Day 14n=12 Participants	-5.8789	2.3576
Reaction time for anger - Change from baseline to Day 7n=12 Participants	-25.03	165.47

Least Squares Mean5.482295% CI0.0575 - 10.9069p0.0479Mixed Models Analysis

Between treatment analysis for Accuracy for happiness - change from baseline to Day 14.

Least Squares Mean4.795495% CI0.9843 - 8.6064p0.0161Mixed Models Analysis

Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14

Least Squares Mean167.2995% CI25.36 - 309.23p0.0237Mixed Models Analysis

Between treatment analysis of Reaction time for anger - change from baseline to Day 7

Least Squares Mean-1.276195% CI-9.2424 - 6.6902p0.7188Mixed Models Analysis

Between treatment analysis for Accuracy for happiness - change from baseline to Day 14

Least Squares Mean1.895595% CI-4.9026 - 8.6935p0.5478Mixed Models Analysis

Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14

Least Squares Mean-7.5295% CI-291.21 - 276.17p0.9510Mixed Models Analysis

Between treatment analysis of Reaction time for anger - change from baseline to Day 7

Secondary/protocol endpoint

Change From Baseline in CANTAB Cognitive Assessments

Time frame:Days 1, 7, 14 of each Treatment Period (Two 14-day periods)

change from baseline, improvement

Secondary/registry result

Change From Baseline in CANTAB Cognitive Assessments

Time frame:Days 1, 7, 14 of each Treatment Period (Two 14-day periods)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Words	Standard error
PD - PlaceboImmediate Word Recall: Number of words - Change from Baseline to Day 1, 4 hours post dosen=25 Participants	-0.50	0.375
Immediate Word Recall: Number of words - Change from Baseline to Day 14, 4 hours post dosen=24 Participants	0.20	0.380
Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post dosen=25 Participants	-2.50	0.556
Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post dosen=23 Participants	-1.17	0.572
Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hrs post-dosen=23 Participants	-1.94	0.474
PD - ActiveImmediate Word Recall: Number of words - Change from Baseline to Day 1, 4 hours post dosen=23 Participants	0.18	0.385
Immediate Word Recall: Number of words - Change from Baseline to Day 14, 4 hours post dosen=24 Participants	1.32	0.380
Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post dosen=23 Participants	-0.78	0.572
Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post dosen=24 Participants	0.13	0.564
Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hrs post-dosen=24 Participants	-0.24	0.466
MCI - PlaceboImmediate Word Recall: Number of words - Change from Baseline to Day 1, 4 hours post dosen=12 Participants	0.89	0.531
Immediate Word Recall: Number of words - Change from Baseline to Day 14, 4 hours post dosen=12 Participants	1.89	0.531
Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post dosen=10 Participants	0.64	0.824
Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post dosen=12 Participants	0.37	0.776
Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hrs post-dosen=12 Participants	-0.44	0.891
MCI - ActiveImmediate Word Recall: Number of words - Change from Baseline to Day 1, 4 hours post dosen=13 Participants	0.83	0.514
Immediate Word Recall: Number of words - Change from Baseline to Day 14, 4 hours post dosen=12 Participants	1.65	0.530
Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post dosen=12 Participants	0.59	0.770
Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post dosen=12 Participants	1.34	0.775
Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hrs post-dosen=12 Participants	0.40	0.889
PDD or DLB - PlaceboImmediate Word Recall: Number of words - Change from Baseline to Day 1, 4 hours post dosen=3 Participants	-1.96	0.474
Immediate Word Recall: Number of words - Change from Baseline to Day 14, 4 hours post dosen=2 Participants	-2.79	0.514
Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post dosen=3 Participants	-1.44	0.431
Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post dosen=2 Participants	1.01	0.518
Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hrs post-dosen=2 Participants	-3.67	1.109
PDD or DLB - ActiveImmediate Word Recall: Number of words - Change from Baseline to Day 1, 4 hours post dosen=2 Participants	-0.12	0.514
Immediate Word Recall: Number of words - Change from Baseline to Day 14, 4 hours post dosen=2 Participants	-1.29	0.514
Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post dosen=2 Participants	0.51	0.518
Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post dosen=2 Participants	0.01	0.518
Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hrs post-dosen=2 Participants	-6.17	1.109

Least Squares Mean0.6895% CI-0.066 - 1.432p0.0737Mixed Models Analysis

Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose

Least Squares Mean1.1295% CI0.382 - 1.868p0.0033Mixed Models Analysis

Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose

Least Squares Mean1.7295% CI0.600 - 2.840p0.0029Mixed Models Analysis

Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose

Least Squares Mean1.2995% CI0.168 - 2.418p0.0247Mixed Models Analysis

Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose

Least Squares Mean1.6995% CI0.653 - 2.732p0.0016Mixed Models Analysis

Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hours post-dose

Least Squares Mean-0.0695% CI-1.127 - 1.009p0.9126Mixed Models Analysis

Between treatment analysis for Immediate Word recall: number of words - Change from Baseline to Day 1, 4 hours post-dose

Least Squares Mean-0.2495% CI-1.317 - 0.837p0.6570Mixed Models Analysis

Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose

Least Squares Mean-0.0695% CI-1.787 - 1.669p0.9458Mixed Models Analysis

Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose

Least Squares Mean0.9795% CI-0.642 - 2.579p0.2327Mixed Models Analysis

Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose

Least Squares Mean0.8495% CI-1.208 - 2.879p0.4154Mixed Models Analysis

Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to day 7, 4 hours post-dose

Behavior / neuropsychiatric

6 endpoints

Secondary/protocol endpoint

Digital Wearable Device (BioStamp) - Sleeping Heart Rate

Time frame:Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

descriptive

Secondary/protocol endpoint

Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV)

Time frame:Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

descriptive

Secondary/protocol endpoint

Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)

Time frame:Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

descriptive

Secondary/registry result

Digital Wearable Device (BioStamp) - Sleeping Heart Rate

Time frame:Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

descriptive

Posted result

Group	Value (least_squares_mean), beats per minute	Standard error
PD - Placebon=7 Participants	-0.39	0.466
PD - Activen=8 Participants	4.59	0.480
Overall - Placebon=9 Participants	-0.39	0.394
Overall - Activen=9 Participants	4.67	0.405

Least Squares Mean5.0695% CI3.956 - 6.160p<0.0001Mixed Models Analysis

Between treatment analysis (active - placebo) for Sleeping Heart Rate change from baseline across periods

Secondary/registry result

Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV)

Time frame:Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

descriptive

Posted result

Group	Value (least_squares_mean), ratio	Standard error
PD - Placebon=7 Participants	-0.26	0.325
PD - Activen=8 Participants	0.74	0.330
Overall - Placebon=9 Participants	-0.18	0.324
Overall - Activen=9 Participants	0.82	0.329

Least Squares Mean1.0095% CI0.432 - 1.565p0.0017Mixed Models Analysis

Between treatment analysis (active - placebo) for sleeping HRV change from baseline across periods.

Secondary/registry result

Digital Wearable Device (BioStamp) - Sleeping Heart Rate Variability (HRV) - Root Mean Square of Successive Differences (RMSSD)

Time frame:Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

descriptive

Posted result

Group	Value (least_squares_mean), RMSSD	Standard error
PD - Placebon=7 Participants	2.40	3.101
PD - Activen=8 Participants	-7.41	3.184
Overall - Placebon=9 Participants	-1.16	3.229
Overall - Activen=9 Participants	-11.37	3.292

Least Squares Mean-10.2295% CI-16.867 - -3.567p0.0049Mixed Models Analysis

Between treatment analysis (active - placebo) for sleeping HRV root mean square of successive differences change from baseline across periods

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Change From Baseline in Cognitive Fluctuations

Time frame:Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods)

change from baseline, improvement

Primary/registry result/low confidence

Change From Baseline in Cognitive Fluctuations

Time frame:Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods)

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PDD or DLB PlaceboHow great is the difference between the worst and the best period of function on that day?n=3 Participants	2	-
Length of time sleeping during day.n=3 Participants	2	-
How often is patient drowsy and lethargic during the day?n=3 Participants	1	-
Overall, how would you rate the patient's level of consciousness on a usual day?n=3 Participants	2	-
PDD + DLB - ActiveHow great is the difference between the worst and the best period of function on that day?n=2 Participants	2	-
Length of time sleeping during day.n=2 Participants	1	-
How often is patient drowsy and lethargic during the day?n=2 Participants	1	-
Overall, how would you rate the patient's level of consciousness on a usual day?n=2 Participants	2	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.