NCT05104463

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease

A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Effects of CST-2032 and CST-107 on Cognition in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: CuraSen Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, randomized, placebo-controlled, double-blind, crossover study to evaluate the effects CST-2032 administered with CST-107 on cognition in participants with Mild Cognitive Impairment (MCI) or mild dementia.

Detailed description

Approximately 60 participants will be enrolled in a 2 period, 2-way crossover design following study eligibility confirmation during the screening period. During each treatment period, subjects will receive daily doses of CST-2032 administered with CST-107 or matching placebo for 14 days. Each treatment period will be separated by a washout period of at least 7 days and up to 21 days. All participants will complete clinical, cognitive and pharmacodynamic assessments during each treatment period. PK blood samples will be collected prior to, during and after study medication administration.

Conditions

• Mild Cognitive Impairment
• Dementia

Interventions

Type	Name	Description
DRUG	CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107	CST-2032 and matching placebo white tablets, CST-107 and matching placebo yellow tablets

Timeline

• Start date: 2022-04-11
• Primary completion: 2023-12-20
• Completion: 2024-02-01
• First posted: 2021-11-03
• Last updated: 2025-01-23
• Results posted: 2025-01-23

Locations

15 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study