Completed

Investigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx)

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What is being tested

Rivastigmine

Drug
Who is being recruted

Alzheimer Disease

+ Cognition Disorders
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: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40 countries for Alzheimer's disease to date, including all 15 member states of the European Union, New Zealand, Argentina, Brazil and Mexico. Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo. Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day) for the majority of the study. At every regular visit scheduled every three months, patients will be given basic efficacy and safety assessments. These assessments will include evaluation of adverse events, vital signs, activities of daily living, and clinical staging scales to determine if the subject may have converted to dementia.

Official TitleInvestigation Into Delay to Diagnosis of Alzheimer's Disease With Exelon (InDDEx) 
Principal SponsorNovartis
Last updated: June 24, 2005
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.
Design Details
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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 55 to 85 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer Disease
Cognition Disorders
Criteria
6 inclusion criteria required to participate
Are aged 55-85 years, inclusive. Subjects older than 85 years may be eligible to participate, with approval of the designated study medical monitor
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)
Are cooperative, able to ingest oral medication, and willing to complete all aspects of the study
Will provide written informed consent prior to their participation in the study

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25 exclusion criteria prevent from participating
Advanced, severe, and unstable disease of any type that may interfere with primary and secondary variable evaluations including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the subject to a significant degree or put the subject at special risk
Cognitive impairment sufficient to warrant a diagnosis of dementia
Met the DSM-IV and NINCDS-ADRDA criteria for AD
A clinical diagnosis of AD

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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 CentersPeoria, United StatesSee the location
Suspended
University of California, IrvineOrange, United States
Suspended
University of Colorado Health Sciences CenterDenver, United States
Suspended
Neuromedical Research Institute (Offices in Ft. Lauderdale, Miami Beach and Boca Raton)Ft. Lauderdale, United States
Completed15 Study Centers