drugset / Trial / NCT02051335

Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults

NCT02051335 ↗

Phase 1 Completed 27 enrolled AstraZeneca
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether scopolamine-induced cognitive impairment is attenuated by the administration of roflumilast in combination with donepezil.

Timeline

Start
2014-01
Primary completion
2014-05
Completion
2014-05

Outcome

Mixed primary results

registry A: Placebo vs B: Donepezil 10 mg; p = 0.573; LS mean difference -0.31 (95% CI -1.4 to 0.8) NCT02051335 ↗

registry A: Placebo vs D: Roflumilast Dose A + Donepezil 10 mg; p = 0.042; LS mean difference 2.01 (95% CI 0.1 to 4.0) NCT02051335 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule 10 mg Oral
Subject Roflumilast Small molecule — Oral
Background Scopolamine Unknown 0.5 mg Subcutaneous

Indications