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

This study has been completed.
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Noscira SA
ClinicalTrials.gov Identifier:
NCT01350362
First received: May 6, 2011
Last updated: October 1, 2012
Last verified: October 2012

May 6, 2011
October 1, 2012
April 2011
July 2012   (final data collection date for primary outcome measure)
ADAS-Cog+ [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
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+)
Same as current
Complete list of historical versions of study NCT01350362 on ClinicalTrials.gov Archive Site
  • Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: tideglusib
    1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
    Other Names:
    • NP-12
    • NP031112
  • 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
    Other Names:
    • NP-12
    • NP031112
  • Drug: tideglusib
    500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
    Other Names:
    • NP-12
    • NP031112
  • Drug: Placebo
    Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
    Other Names:
    • NP-12
    • NP031112
  • Experimental: Tideglusib 1000 mg Q.D.
    Group dosed with 1000 mg once daily for 26 weeks/extension
    Intervention: Drug: tideglusib
  • Experimental: Tideglusib 1000 mg Q.O.D.
    Group dosed with 1000 mg once every other day for 26 weeks/extension
    Intervention: Drug: tideglusib
  • Experimental: Tideglusib 500 mg Q.D.
    Group dosed with 500 mg once daily for 26 weeks/extension
    Intervention: Drug: tideglusib
  • Placebo Comparator: Placebo
    Once daily administration for 26 weeks/extension
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
October 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   Spain,   United Kingdom
 
NCT01350362
NP031112-10B04
Yes
Noscira SA
Noscira SA
ICON Clinical Research
Study Director: Teodoro del Ser, PhD Noscira SA
Noscira SA
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP