Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01350362 | Efficacy, Safety and Tolerability of Tideglusib to Treat Mild-to-Moderate Alzheimer's Disease Patients | PHASE2 | COMPLETED | 306 | — | — | Apr 1, 2011 | Oct 1, 2012 | Oct 2, 2012 | 6 | Belgium, Finland +4 |
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+)
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
|---|---|---|
| tideglusib | DRUG | 1000 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. |
Main Inclusion Criteria: 1. Men and women (of non-childbearing potential) with a diagnosis of probable Alzheimer's disease. 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 Main ...