NCT00948259

Safety Study of a Glycogen Synthase Kinase 3 (GSK3) Inhibitor in Patients With Alzheimer´s Disease

Phase IIa 20 Week Double-blind, Placebo-controlled, Randomized, Escalating Dose Study to Evaluate the Safety and Tolerability of Four Oral Doses of NP031112, a Novel GSK3 Inhibitor, in Mild to Moderate Alzheimer's Disease Patients With Stable Anticholinesterasic Treatment.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Noscira SA · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if 4 escalating doses during 20 weeks of NP031112 are safe and tolerated in patients with Alzheimer´s disease.

Conditions

• Alzheimer´s Disease

Interventions

Type	Name	Description
DRUG	NP031112	unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)
DRUG	Placebo	unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-07-29
• Last updated: 2009-11-11

Locations

3 sites across 1 country: Germany