MedTrace Logo

Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients

NCT01350362 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2012-10-02

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the cognitive changes after administration of tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in patients with mild to moderate Alzheimer's disease.

After the 26 week core treatment period, the patients may continue in the study under blinded conditions for an optional extension period up to a maximum of 39 additional weeks (total study duration up to 65 weeks), until the last patient in the study has completed the 26 week of treatment.

Conditions

Interventions

DRUG

tideglusib

1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.

DRUG

tideglusib

1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension

DRUG

tideglusib

500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.

DRUG

Placebo

Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Noscira SA

    lead INDUSTRY

Principal Investigators

  • Teodoro del Ser, PhD · Noscira SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-07-31
Completion
2012-10-31

Countries

  • Belgium
  • Finland
  • France
  • Germany
  • Spain
  • United Kingdom

More Related Trials

Entities

Drugs
Diseases

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 NCT01350362 on ClinicalTrials.gov