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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
306
1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension
500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
Unnamed facility
Leuven and 4 Additional Cities, Belgium
Unnamed facility
Turku and 3 Additional Cities, Finland
Unnamed facility
Paris and 10 Additional Cities, France
Unnamed facility
Freiburg and 5 Additional Cities, Germany
ADAS-Cog+
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+)
Time frame: 26 weeks
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
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Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
Unnamed facility
Madrid and 7 Additional Cities, Spain
Unnamed facility
London and 11 Additional Cities, United Kingdom
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