A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodeg… (NCT04739423) | Clinical Trial Compass
CompletedPhase 2
A Study of Clenbuterol (CST-103) Co-administered With Nadolol (CST-107) in Subjects With Neurodegenerative Disorders
Australia, New Zealand, United Kingdom41 participantsStarted 2021-06-28
Plain-language summary
This is a Phase II, randomized, placebo-controlled, double-blind, crossover study on the CNS and pharmacodynamic effects of clenbuterol (CST-103) co-administered with nadolol (CST-107) in 4 subject populations with Neurodegenerative Disorders.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Dementi…
What they're measuring
1
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Timeframe: Days 7 and 14 of each Treatment Period (Two 14-day periods)
2
Change From Baseline in Cognitive Fluctuations
Timeframe: Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods)