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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01350362
• Date of registration: 06/05/2011
• Prospective Registration: No
• Primary sponsor: Noscira SA
• Public title: Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients ARGO
• Scientific 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
• Date of first enrolment: April 2011
• Target sample size: 306
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01350362
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Teodoro del Ser, PhD
• Affiliation: Noscira SA

Key inclusion & exclusion criteria

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.



Age minimum: 50 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

Drug: tideglusib

Drug: Placebo

Primary Outcome(s)

ADAS-Cog+ [Time Frame: 26 weeks]

Secondary Outcome(s)

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) [Time Frame: 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) [Time Frame: 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 t, phospho-t, and ß-amyloid in CSF and change in MRI measures. [Time Frame: 26 weeks]

Adverse events (AEs): Number of AEs and patients with an incidence rate of = 5% AEs [Time Frame: 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 [Time Frame: 26 weeks]

Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test [Time Frame: 26 weeks]

Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI) [Time Frame: 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) [Time Frame: 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). [Time Frame: 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) [Time Frame: 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) [Time Frame: 26 weeks]

Secondary ID(s)

NP031112-10B04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ICON Clinical Research