At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating EVP-6124 (0.1 mg/day), EVP-6124 (0.3 mg/day), and 4 other interventions for Alzheimer's Disease and Central Nervous System Diseases. Completed, enrolled 49 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
EVP-6124 was administered as one 0.1 mg capsule per day for 28 days.
EVP-6124 was administered as one 0.3 mg capsule every day for 28 days.
EVP-6124 was administered as one 1.0 mg capsule every day for 28 days.
Matching placebo was administered as one capsule per day for 28 days.
Concomitant therapy with donepezil at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.
Concomitant therapy with rivastigmine at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.