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PPD™ CorEvitas™ International Alzheimer's (ALZ) Drug Safety and Effectiveness Registry
The design is an open-ended, prospective, observational, (non-interventional) registry for subjects with mild cognitive impairment (MCI), early symptomatic Alzheimer's disease, Alzheimer's disease, or dementia with clinical suspicion of Alzheimer's disease under the care of a neurologist, psychiatrist, geriatrician or other qualified provider. Longitudinal data are collected from subjects, their care partner(s), and their treating healthcare provider during routine clinical encounters using a structured and standardized data collection method. Approximately 2,000 subjects, with no defined upper limit, across around 75 clinical sites worldwide will be recruited.
The objective of the registry is to create a prospective cohort of Alzheimer's disease subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for Alzheimer's disease. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: Evaluating the effectiveness and safety of commercially available medications for the treatment of Alzheimer's disease, Providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, Research related to drug utilization, disease burden, and unmet needs and Supporting post-authorization safety studies to generate evidence related to real world safety of medications used for the treatment of the disease(s) under study
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
CorEvitas, LLC
Waltham, Massachusetts, United States
Start Date
November 24, 2025
Primary Completion Date
December 31, 2099
Completion Date
December 31, 2099
Last Updated
February 19, 2026
2,000
ESTIMATED participants
Lead Sponsor
CorEvitas
NCT04123314
NCT07178210
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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