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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: tideglusib

• Registration Number: NCT01350362
• Lead Sponsor: Noscira SA

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Primary Completion: 2012-07
• Status Verified: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Once daily administration for 26 weeks/extension
Tideglusib 1000 mg Q.O.D.	tideglusib	Group dosed with 1000 mg once every other day for 26 weeks/extension
Tideglusib 1000 mg Q.D.	tideglusib	Group dosed with 1000 mg once daily for 26 weeks/extension
Tideglusib 500 mg Q.D.	tideglusib	Group dosed with 500 mg once daily for 26 weeks/extension

Primary Outcome Measures

Name	Time	Method
ADAS-Cog+	26 weeks	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+)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test	26 weeks
Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs	26 weeks
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
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
Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI)	26 weeks
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
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
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
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
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
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 τ, phospho-τ, and β-amyloid in CSF and change in MRI measures.	26 weeks