A Phase 1 Study to Evaluate the Safety, Pharmacokinetic (PK) and Effects of CST-2032 in Healthy Volunteers and Subjects with Mild Cognitive Impairment or Parkinson’s Disease

Phase 1

• Conditions: Mild Cognitive Impairment; Parkinson's disease; Neurological - Parkinson's disease; Neurological - Other neurological disorders; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12620000957998
• Lead Sponsor: CuraSen Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-25
• Study Completion: 2021-10-01
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

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

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified