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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01181310 | Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED) | PHASE1 | COMPLETED | 31 | — | — | Jun 1, 2007 | Oct 1, 2007 | Nov 6, 2015 | - | — |
Participants learned a hidden pathway through a maze (10 x 10 grid of tiles on a computer touch screen) using step-by-step guess, with trial and error feedback after each step. Once the pathway was learned, participants repeated the same pathway four more times. The number of pathway errors was used to indicate the level of cognitive function.
| Arm | Type | Description |
|---|---|---|
| A, B, D, E, C | EXPERIMENTAL | Participants received treatment A, B, D, E, C for Periods 1, 2, 3, 4, and 5, respectively. |
| B, C, E, A, D | EXPERIMENTAL | Participants received treatment B, C, E, A, D for Periods 1, 2, 3, 4, and 5, respectively. |
| C, D, A, B, E | EXPERIMENTAL | Participants received treatment C, D, A, B, E for Periods 1, 2, 3, 4, and 5, respectively. |
| D, E, B, C, A | EXPERIMENTAL | Participants received treatment D, E, B, C, A for Periods 1, 2, 3, 4, and 5, respectively. |
| E, A, C, D, B | EXPERIMENTAL | Participants received treatment E, A, C, D, B for Periods 1, 2, 3, 4, and 5, respectively. |
| A, C, B, E, D | EXPERIMENTAL | Participants received treatment A, C, B, E, D for Periods 1, 2, 3, 4, and 5, respectively. |
| B, D, C, A, E | EXPERIMENTAL | Participants received treatment B, D, C, A, E for Periods 1, 2, 3, 4, and 5, respectively. |
| C, E, D, B, A | EXPERIMENTAL | Participants received treatment C, E, D, B, A for Periods 1, 2, 3, 4, and 5, respectively. |
| D, A, E, C, B | EXPERIMENTAL | Participants received treatment D, A, E, C, B for Periods 1, 2, 3, 4, and 5, respectively. |
| E, B, A, D, C | EXPERIMENTAL | Participants received treatment E, B, A, D, C for Periods 1, 2, 3, 4, and 5, respectively. |
| Name | Type | Description |
|---|---|---|
| A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine | DRUG | Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ. |
| B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg | DRUG | Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ. |
| C: MK-3134 25 mg + Scopolamine 0.5 mg | DRUG | A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg. |
| D: Donepezil 10 mg + Scopolamine 0.5 mg | DRUG | A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ. |
| E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg | DRUG | A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ. |
Participants were eligible for inclusion in the study who were: * Male between 18 and 40 years of age. * Non-smokers, in good health (as defined in protocol), and were willing to follow study-related procedures. Participants were not eligible for inclusion in the study if they: * Had a history of...