NCT05033912

A Study of CST-2032 in Subjects With Cognitive Impairment

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CuraSen Therapeutics, Inc. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effects of CST-2032 when administered with pre-administered CST-107 on safety, tolerability, cognition, cerebral perfusion, and cerebral metabolism in patients with cognitive impairment.

Detailed description

This is a phase1, randomized sequence of placebo, low-, mid- and high-dose CST-2032 in Subjects with cognitive impairment. Sixteen (16) subjects with cognitive impairment will be enrolled. The first subject enrolled will be dosed as a sentinel. If no significant safety issues are noted in the sentinel subject, the remaining subjects will be dosed starting 24 hours after the Day 4 dose for the sentinel subject. Subjects will have the option to attend all study visits as outpatients or be admitted for a 4-5-night confinement period at the research facility. Subjects will receive matching placebo for CTS-2032, 1mg, 3mg, and 9 mg CST-2032 two hours after a pre-administered dose of 3 mg CST-107 in a randomized sequence on Days 1, 2, 3 and 4. Cognitive assessments (CANTAB) and a verbal fluency test will be administered daily. If operationally feasible, subjects will also undergo arterial spin labeling (ASL) magnetic resonance (MRI) imaging of the brain on Days 1 and 4.

Conditions

• Mild Cognitive Impairment (MCI)
• Parkinson Disease (PD)

Interventions

Type	Name	Description
DRUG	CST-2032, matching placebo for CST-2032, CST-107	CST-2032 and matching placebo oral liquid; CST-107 white capsules

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-03-01
• Completion: 2022-05-01
• First posted: 2021-09-05
• Last updated: 2021-10-28

Regulatory

• FDA-regulated drug study