NCT06427668

Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)

A Phase 2, Randomized, Placebo-controlled, Double-Blind Multicenter Study to Assess the Safety, Tolerability, and Pharmacodynamics (PD) in Adult Participants With Mild-to Moderate Alzheimer's Disease (AD) Administered SPG302

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Spinogenix · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.

Detailed description

This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts: Part A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles Part B: a randomized expansion cohort of daily dosing for 28 day cycles

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	SPG302	synthetic small molecule
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-07-29
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2024-05-24
• Last updated: 2025-08-17

Locations

2 sites across 1 country: Australia