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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tideglusib 1000 mg Q.D. | Experimental | Group dosed with 1000 mg once daily for 26 weeks/extension |
|
| Tideglusib 1000 mg Q.O.D. | Experimental | Group dosed with 1000 mg once every other day for 26 weeks/extension |
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| Tideglusib 500 mg Q.D. | Experimental | Group dosed with 500 mg once daily for 26 weeks/extension |
|
| Placebo | Placebo Comparator | Once daily administration for 26 weeks/extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tideglusib | Drug | 1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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+) | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs | 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). |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teodoro del Ser, PhD | Noscira SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leuven and 4 Additional Cities | Belgium | |||||
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C520571 | tideglusib |
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| tideglusib | Drug | 1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension |
|
|
| tideglusib | Drug | 500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension. |
|
|
| Placebo | Drug | Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension. |
|
|
| 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) | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test | 26 weeks |
| Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI) | 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) | 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) | 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) | 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) | 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 | 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. | 26 weeks |
| 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 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |