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

Alzheimer's Disease Clinical Trial

— ARGO  

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, 4-arm, 26 Week Parallel-Group Study to Evaluate Efficacy, Safety and Tolerability of 2 Oral Doses and 2 Regimes of Tideglusib vs Placebo in Mild-to-Moderate AD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350362
• Other study ID #: NP031112-10B04
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2011
• Last updated: October 1, 2012
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Noscira SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicinal Products and Health ProductsFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

This double-blind, placebo-controlled, randomized, parallel group study will be conducted at multiple centers in the European Union. Patients with mild to moderate Alzheimer's disease will undergo a screening period, and then they will be randomized to one of these four groups: tideglusib 1000 mg once daily (Q.D.), tideglusib 1000 mg every other day (Q.O.D.), tideglusib 500 mg Q.D., or matching placebo, for a 26-week, double-blind, placebo-controlled treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Main Inclusion Criteria:

1. Men and women (of non-childbearing potential) with a diagnosis of probable Alzheimer's disease.

2. Age of 50 to 85 years.

3. MMSE score 14 to 26.

4. Well-tolerated treatment with one of the approved Acetylcholinesterase-Inhibitors and/or Memantine in a stable dose

Main Exclusion Criteria:

1. Significant psychiatric on medical disease.

2. Any chronic liver disease as indicated by out of range values of ALAT, ASAT or direct bilirubin, clinically relevant hepatic steatosis or other clinical manifestations of liver disease

3. Chronic daily drug intake of excluded concomitant medications.

4. Enrollment in another investigational drug study within 3 months before the baseline visit.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• tideglusib
1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
• tideglusib
1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension
• tideglusib
500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
• Placebo
Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Noscira SA	ICON Clinical Research

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-Cog+	The change from Baseline of the 3 active study medication groups will be compared with the placebo group in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog+)	26 weeks	No
Secondary	Adverse events (AEs): Number of AEs and patients with an incidence rate of = 5% AEs		26 weeks	Yes
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Alzheimer's Disease Cooperative Study Unit Activities of Daily Living (ADCS-ADL).		26 weeks	No
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Mini Mental State Examination (MMSE)		26 weeks	No
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test		26 weeks	No
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI)		26 weeks	No
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Geriatric Depression Scale (GDS)		26 weeks	No
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Clinical Global Impression of Change (CGIC)		26 weeks	No
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the European Quality of life Instrument (EQ-5D)		26 weeks	No
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Caregiver time (RUD Lite)		26 weeks	No
Secondary	Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Questionnaire on urinary incontinence		26 weeks	No
Secondary	Exploratory Endpoints (only in a subgroup of patients at predefined sites): Change from Baseline of the 3 active study medication groups will be compared with the placebo group in levels of t, phospho-t, and ß-amyloid in CSF and change in MRI measures.		26 weeks	Yes