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NCT Number: NCT01350362

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leuven and 4 Additional Cities, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Men and women (of non-childbearing potential) with a diagnosis of probable Alzheimer's disease.
  • Age of 50 to 85 years.
  • MMSE score 14 to 26.
  • Well-tolerated treatment with one of the approved Acetylcholinesterase-Inhibitors and/or Memantine in a stable dose

Main Exclusion Criteria:

  • Significant psychiatric on medical disease.
  • 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
  • Chronic daily drug intake of excluded concomitant medications.
  • Enrollment in another investigational drug study within 3 months before the baseline visit.

Treatment and study plan

Tideglusib

Drug

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

Placebo

Drug

Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.

Other names: NP-12, NP031112

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Noscira SA

Industry

Collaborators

  • ICON Clinical Research

Registry information

Official study 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

Acronym: ARGO

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 9, 2011
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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