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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00277810 | Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease | PHASE2 | COMPLETED | 250 | — | — | Mar 1, 2006 | Jun 1, 2008 | Jul 7, 2020 | 83 | United States, Argentina +9 |
| NCT00151398 | Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD) | PHASE2 | COMPLETED | 229 | — | — | Oct 6, 2005 | Mar 15, 2008 | May 6, 2022 | 56 | United States, Argentina +3 |
| NCT00563732 | Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin | PHASE1 | COMPLETED | - | — | — | Dec 1, 2007 | Sep 1, 2008 | Sep 9, 2008 | - | — |
| NCT00494962 | Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects | PHASE1 | COMPLETED | 40 | — | — | Jun 1, 2007 | Jun 1, 2007 | Dec 5, 2007 | 1 | Germany |
| NCT00499642 | Study Evaluating the Effect of Lecozotan SR on the QTc Interval | PHASE1 | COMPLETED | - | — | — | Jun 1, 2007 | Aug 1, 2007 | Dec 28, 2007 | 2 | France |
| NCT00366483 | Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects | PHASE1 | COMPLETED | 40 | — | — | May 1, 2006 | - | Mar 16, 2007 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| lecozotan SR (SRA-333) | DRUG | one of 3 doses of lecozotan sr dose for 6 months as an extension to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr |
| lecozotan SR | DRUG | evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil. |
| Donepezil | DRUG | 10 mg donepezil QD dosed up to 40 weeks |
| Lecozotan | DRUG | - |
| Moxifloxacin | DRUG | - |
Inclusion Criteria: * Diagnosis of probable Alzheimer's disease * Current use of cholinesterase inhibitor * Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at ...