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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: tideglusib Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tideglusib 1000 mg Q.D.
Group dosed with 1000 mg once daily for 26 weeks/extension
 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
Experimental: Tideglusib 1000 mg Q.O.D.
Group dosed with 1000 mg once every other day for 26 weeks/extension
 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
Experimental: Tideglusib 500 mg Q.D.
Group dosed with 500 mg once daily for 26 weeks/extension
 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
Placebo Comparator: Placebo
Once daily administration for 26 weeks/extension
 Drug: Placebo
Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Other Names:
  • NP-12
  • NP031112


Outcome Measures
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Primary Outcome Measures :
  1. 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+)


Secondary Outcome Measures :
  1. Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs [ Time Frame: 26 weeks ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350362


Locations
Belgium
Leuven and 4 additional cities, Belgium
Finland
Turku and 3 additional cities, Finland
France
Paris and 10 additional cities, France
Germany
Freiburg and 5 additional cities, Germany
Spain
Madrid and 7 additional cities, Spain
United Kingdom
London and 11 additional cities, United Kingdom
Sponsors and Collaborators
Noscira SA
ICON Clinical Research
Investigators
Study Director: Teodoro del Ser, PhD Noscira SA
More Information
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Responsible Party: Noscira SA
ClinicalTrials.gov Identifier: NCT01350362     History of Changes
Other Study ID Numbers: NP031112-10B04
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: October 2012

Keywords provided by Noscira SA:
tideglusib
Alzheimer
NP-12
 NP031112
ARGO
Noscira

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders