NCT06995573

A Study to Assess Safety and Tolerability and to Explore Efficacy of NSC001 in Mild to Moderate Alzheimer's Disease

A Phase 2a, Multi-Center, Randomized, Parallel Group, Double Blind and Placebo-controlled Clinical Trial to Assess Safety and Tolerability as Well as Explorative Efficacy of the Orthosteric Selective Muscarinic M1 Agonist NSC001 in Mild to Moderate Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: NSC-Therapeutics · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of NSC001 on in patients with mild to moderate Alzheimer's disease and to evaluate the influence of the compound on cognitive function.

Detailed description

NSC001 is an orally administered small molecule rigid cholinergic agonist that has a high selectivity for M1 muscarinic receptors (MI), designed to improve cognitive and behavioral function in patients with Alzheimer's Disease (AD). The primary pharmacology available for NSC001 from preclinical models and studies in healthy volunteers provides a compelling rationale for the evaluation of the safety and tolerability of this compound in patients with mild to moderate AD and for the investigation of NSC001 effects on cognitive function and behavior in such patients.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	NSC001	rigid, orthosteric acetylcholine analog, highly specific for M1 muscarinic receptor
OTHER	Placebo	matching placebo to NSC001

Timeline

• Start date: 2025-08-25
• Primary completion: 2026-07-30
• Completion: 2026-09-30
• First posted: 2025-05-29
• Last updated: 2026-04-17

Locations

10 sites across 2 countries: Austria, Germany