Alzheimer's Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Phase 1b Safety Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Patients With Mild to Moderate Probable Alzheimer's Disease
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.
This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose
levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking
an AChEI medication (donepezil or rivastigmine).
Study drug will be supplied as capsules and will be orally administered once daily for a
total of 28 days. Eligible subjects will be admitted to an inpatient study unit on Day -2
(two days before the first dose of study drug is administered) and will remain confined to
the inpatient study unit for a total of five days. Starting on Day 4, subjects will continue
the study in the outpatient setting, with study visits on Days 7, 14, 21, and 28. Safety
assessments, PK sampling, and cognitive testing will be performed inpatient and at each
study visit.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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