Completed

Exelon vs. Placebo in Delaying Alzheimer's Disease Diagnosis in MCI Patients

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Study Aim

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.

What is being tested

Data Collection

Who is being recruted

Alzheimer Disease+8

+ Mental Disorders

+ Brain Diseases

From 55 to 85 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorNovartis
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleInvestigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)
Principal SponsorNovartis
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesCognitive Dysfunction

Criteria

6 inclusion criteria required to participate
Are cooperative, able to ingest oral medication, and willing to complete all aspects of the study.

Are aged 55-85 years, inclusive. Subjects older than 85 years may be eligible to participate, with approval of the designated study medical monitor.

Will provide written informed consent prior to their participation in the study.

Are male or female without child-bearing potential (i.e., surgically sterilized [via bilateral tubal ligation,bilateral oophorectomy, or hysterectomy], at least one year postmenopausal, or using adequate birth control).

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25 exclusion criteria prevent from participating
A current diagnosis of severe and unstable cardiovascular disease.

Exclude if T3 uptake is less than 19%; T4 less than 2.9 ((g/dL); free T4 index is less than 0.8

A clinical diagnosis of AD.

A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, severe language difficulty).

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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

Suspended

Medici Research Centers

Peoria, United StatesOpen Medici Research Centers in Google Maps
Suspended

University of California, Irvine

Orange, United States
Suspended

University of Colorado Health Sciences Center

Denver, United States
Suspended

Neuromedical Research Institute (Offices in Ft. Lauderdale, Miami Beach and Boca Raton)

Fort Lauderdale, United States
Completed15 Study Centers