An Open-Label Ascending Single-Dose, and Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CST-2032 in Healthy Volunteers and Subjects with Mild Cognitive Impairment or Parkinson’s Disease

CuraSen Therapeutics, Inc.0 个研究点目标入组 79 人开始时间: 2020年9月25日最近更新: 2022年1月31日

适应症

试验速览

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•Healthy participants must meet the following:
•- Male or female aged 18-50 years or 55-75 in Cohorts D2 and D3
•- Women of child-bearing potential must agree to effective methods of birth control
•- Free from clinical significantly illness or disease
•- No current use of any prescription medications, over-the-counter medications or nutritional supplements.
•MCI patients must meet the following:
•- Male or female aged 45-75 years
•- Women of child-bearing potential must agree to effective methods of birth control
•- Meet the criteria for amnestic MCI, as per the National Institute on Aging-Alzheimer's Association core clinical criteria
•- A score of greater than or equal to one standard deviation below age and educational norms in the Digit Symbol Substitution Test (DSST)
•PD patients must meet the following:
•- Male or female aged 45-75 years
•- Women of child-bearing potential must agree to effective methods of birth control
•- Meet the criteria for PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism
•- Mini-Mental Status Exam (MMSE) Score greater than or equal to 26

•All participants must not meet the following:
•- Women who are pregnant or lactating
•- History of any clinically significant disease or illness
•- Clinically significant laboratory or ECG abnormality.
•- Positive screening test for human immunodeficiency virus (HIV).
•- Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection.
•- Positive screening test for SARs-CoV2 or, if tests are not available, evidence of possible ongoing infection based on body temperature, blood oxygen and Investigator judgment.
•- History of drug or alcohol abuse >12 months prior to Screening.
•- History of nicotine use >6 months.
•- A positive test for drugs of abuse or alcohol
•- Contraindications for MRI scans.
•Other exclusion criteria apply, such as: specific exclusions for background medications, concurrent illness in each of the eligible participant groups (healthy subjects, or subjects with MCI or PD).

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