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

NCT00948259 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-11-11

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Noscira SA

    lead INDUSTRY

Principal Investigators

  • Klaus-Christian Steinwachs, MD · Studienzentrum PD Dr. Steinwachs

  • Manfred Windisch, Ph.D. · JSW Life Sciences GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00948259 on ClinicalTrials.gov