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drugset / Trial / NCT00766363

Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease

NCT00766363 ↗

Phase 1 Completed 49 enrolled FORUM Pharmaceuticals Inc Syneos Health · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inhibitor\]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.

Timeline

Start
2008-10
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule — —
Subject ENCENICLINE Small molecule 0.1 mg Oral
Subject ENCENICLINE Small molecule 0.3 mg Oral
Subject ENCENICLINE Small molecule 1 mg Oral
Subject Rivastigmine Small molecule — —

Indications

Alzheimer disease