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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01350362
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : October 2, 2012
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Noscira SA

Tracking Information
First Submitted Date  ICMJE May 6, 2011
First Posted Date  ICMJE May 9, 2011
Last Update Posted Date October 2, 2012
Study Start Date  ICMJE April 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
ADAS-Cog+ [ Time Frame: 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+)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01350362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
  • 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 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 Mini Mental State Examination (MMSE) [ 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 Geriatric Depression Scale (GDS) [ Time Frame: 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) [ 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 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 Questionnaire on urinary incontinence [ 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 τ, phospho-τ, and β−amyloid in CSF and change in MRI measures. [ Time Frame: 26 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2012)
306
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2011)
280
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   France,   Germany,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01350362
Other Study ID Numbers  ICMJE NP031112-10B04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Noscira SA
Study Sponsor  ICMJE Noscira SA
Collaborators  ICMJE ICON Clinical Research
Investigators  ICMJE
Study Director: Teodoro del Ser, PhD Noscira SA
PRS Account Noscira SA
Verification Date October 2012

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