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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518563-35-00

Acronym

NSC24001

Enrollment

Registered

2025-04-06

Start date

2025-08-25

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

Frequency and severity of AEs and SAEs, Changes in clinical/neurological findings, Changes in vital signs and ECG, Changes in laboratory assessments, Changes in suicidal ideation and suicidal behavior as assessed by C-SSRS

Detailed description

NSC001 (parent) PK parameters as applicable for the regimen including, but not limited to AUC(0 last), AUCinf, Cmax, tmax, CL/F (only parent), Vd/F (only parent), t½, % extrapolated AUCinf, Parent exposure ratios for Cmax and AUC(0-last)

Interventions

DRUGTrospium Aristo 20 mg Filmtabletten

DRUGIdentical with the IMP NSC001 but without the active substance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency and severity of AEs and SAEs, Changes in clinical/neurological findings, Changes in vital signs and ECG, Changes in laboratory assessments, Changes in suicidal ideation and suicidal behavior as assessed by C-SSRS	—

Secondary

Measure	Time frame
NSC001 (parent) PK parameters as applicable for the regimen including, but not limited to AUC(0 last), AUCinf, Cmax, tmax, CL/F (only parent), Vd/F (only parent), t½, % extrapolated AUCinf, Parent exposure ratios for Cmax and AUC(0-last)	—

Countries

Austria, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026