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
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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 |
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Alzheimer's Disease | Drug: tideglusib Drug: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
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Experimental: Tideglusib 1000 mg Q.D.
Group dosed with 1000 mg once daily for 26 weeks/extension
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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:
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Experimental: Tideglusib 1000 mg Q.O.D.
Group dosed with 1000 mg once every other day for 26 weeks/extension
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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:
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Experimental: Tideglusib 500 mg Q.D.
Group dosed with 500 mg once daily for 26 weeks/extension
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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:
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Placebo Comparator: Placebo
Once daily administration for 26 weeks/extension
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Drug: Placebo
Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Other Names:
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- 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+)
- 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 ]

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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 |
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.

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
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 |
Study Director: | Teodoro del Ser, PhD | Noscira SA |
Responsible Party: | Noscira SA |
ClinicalTrials.gov Identifier: | NCT01350362 |
Other Study ID Numbers: |
NP031112-10B04 |
First Posted: | May 9, 2011 Key Record Dates |
Last Update Posted: | October 2, 2012 |
Last Verified: | October 2012 |
tideglusib Alzheimer NP-12 |
NP031112 ARGO Noscira |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |