Exelon vs. Placebo in Delaying Alzheimer's Disease Diagnosis in MCI Patients
This study aims to evaluate if Exelon is effective in delaying the diagnosis of Alzheimer's disease in patients with Mild Cognitive Impairment (MCI), compared to a placebo.
Data Collection
Alzheimer Disease+8
+ Mental Disorders
+ Brain Diseases
Treatment Study
Summary
This study is a phase IIIb trial looking into the delay of Alzheimer's disease diagnosis in individuals with mild cognitive impairment (MCI). The trial focuses on comparing the time it takes for MCI to progress to Alzheimer's disease in participants taking a drug called Exelon versus those taking a placebo. Exelon is currently under review by the U.S. Food and Drug Administration for Alzheimer's disease treatment and is already approved in over 40 countries, including the European Union and several countries in the Americas. The study aims to provide valuable insights into the potential benefits of Exelon in delaying Alzheimer's disease progression. Participants with MCI will be randomly assigned to receive either Exelon or a placebo. Those in the Exelon group will take 1.5 to 6.0 mg twice daily (3.0 to 12 mg/day) for most of the study duration. Every three months, patients will attend regular visits for basic safety and effectiveness assessments. These visits will include evaluations of any adverse events, vital signs, daily living activities, and clinical staging scales to determine if the participant's condition may have progressed to dementia.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 55 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
University of California, Irvine
Orange, United StatesUniversity of Colorado Health Sciences Center
Denver, United StatesNeuromedical Research Institute (Offices in Ft. Lauderdale, Miami Beach and Boca Raton)
Fort Lauderdale, United States