A Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Effects of NTRX-07 in Subjects with Mild Cognitive Impairment (MCI) or Mild to Moderate Alzheimer’s Disease (AD) (SPPN-AD)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517957-29-00

Acronym

NTRX-07-C201

Enrollment

Registered

2025-01-30

Start date

2025-04-02

Completion date

Unknown

Last updated

2025-08-04

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

Conditions

Mild Cognitive Impairment (MCI), Mild to moderate Alzheimer’s Disease (AD)

Brief summary

To determine the safety and tolerability in AD subjects following 28 days of administration of NTRX-07

Detailed description

Plasma and CSF pharmacokinetics of NTRX-07

Interventions

DRUGNTRX-07

DRUGSolid oral dosage Placebo oval tablet of the same size

DRUGshape

DRUGand weight as the active drug product NTRX-07 45 mg tablet

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To determine the safety and tolerability in AD subjects following 28 days of administration of NTRX-07	—

Secondary

Measure	Time frame
Plasma and CSF pharmacokinetics of NTRX-07	—

Countries

Czechia, Hungary, Poland

Outcome results

None listed

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