Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients
NCT ID: NCT01350362
Last Updated: 2012-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
306 participants
INTERVENTIONAL
2011-04-30
2012-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tideglusib 1000 mg Q.D.
Group dosed with 1000 mg once daily for 26 weeks/extension
tideglusib
1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
Tideglusib 1000 mg Q.O.D.
Group dosed with 1000 mg once every other day for 26 weeks/extension
tideglusib
1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension
Tideglusib 500 mg Q.D.
Group dosed with 500 mg once daily for 26 weeks/extension
tideglusib
500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
Placebo
Once daily administration for 26 weeks/extension
Placebo
Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Interventions
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tideglusib
1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
tideglusib
1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension
tideglusib
500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
Placebo
Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
50 Years
85 Years
ALL
No
Sponsors
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ICON Clinical Research
INDUSTRY
Noscira SA
INDUSTRY
Responsible Party
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Principal Investigators
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Teodoro del Ser, PhD
Role: STUDY_DIRECTOR
Noscira SA
Locations
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Leuven and 4 Additional Cities, , Belgium
Turku and 3 Additional Cities, , Finland
Paris and 10 Additional Cities, , France
Freiburg and 5 Additional Cities, , Germany
Madrid and 7 Additional Cities, , Spain
London and 11 Additional Cities, , United Kingdom
Countries
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Other Identifiers
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NP031112-10B04
Identifier Type: -
Identifier Source: org_study_id