Thermo Fisher launches international Alzheimer’s registry to strengthen real-world evidence generation

The new PPD™ CorEvitas™ Alzheimer’s Disease Registry aims to generate harmonized, regulatory-grade real-world data (RWD) to support long-term evaluation of treatment safety, effectiveness, and unmet needs in routine clinical practice.

Thermo Fisher Scientific has announced the enrolment of the first patient in its newly launched PPD CorEvitas Alzheimer’s Disease Registry, marking an expansion of its real-world evidence (RWE) capabilities in neurodegenerative disease. The international, multi-country registry is designed to collect harmonized, longitudinal RWD under a common global protocol, supporting evaluations of drug safety and effectiveness across routine clinical settings. By generating standardized, fit-for-purpose RWE across multiple countries, the registry is positioned to inform regulatory decision-making, clinical practice, and future therapeutic development in Alzheimer’s disease.

Alzheimer’s disease is a progressive neurodegenerative condition characterized by declining memory, cognition, and functional ability. According to a recent report, an estimated 7.2 million people aged 65 years and older are living with Alzheimer’s, a figure projected to double by 2050. Globally, this figure is expected to reach 78 million in 2030 and 139 million in 2050.

As one of the leading causes of death in the US, the disease represents a major public health challenge and highlights the need for robust evidence to guide treatment decisions, regulatory assessments, and care strategies. While no cure currently exists, available therapies may help manage symptoms or slow disease progression, increasing the importance of understanding their real-world performance.

The CorEvitas Alzheimer’s Disease Registry builds on Thermo Fisher’s existing portfolio of PPD CorEvitas Clinical Registries, which collectively span more than 500 investigator sites and include longitudinal data from over 100,000 patients. Like other CorEvitas registries, the Alzheimer’s initiative will capture structured clinician-reported and patient-reported data derived from routine clinical practice, enabling analyses that complement evidence generated through clinical trials.

According to the company, the registry’s longitudinal design will support the evaluation of long-term safety outcomes, treatment patterns, and the evolving use of approved Alzheimer’s therapies in real-world care. It is also intended to help identify unmet medical needs, clarify the disease’s impact on patients and caregivers, and assess clinical outcomes associated with existing treatment options.

“The launch of this registry reflects the power of collaboration between clinicians, industry partners and scientific leaders to accelerate progress in Alzheimer’s disease research,” said Peter Wahl, ScD, vice president and global head of scientific affairs for PPD CorEvitas Clinical Registries at Thermo Fisher Scientific. “Together, we are building a regulatory-grade, RWE foundation that will help shape the understanding of current and next generation of therapies.”

A key focus of the registry is detailed safety monitoring, including MRI-based assessments of brain bleeding and swelling that can occur with certain Alzheimer’s treatments. The registry will also collect data on plaque clearance, an important indicator of treatment effectiveness when considered alongside cognitive outcomes, contributing to a more comprehensive understanding of benefit–risk profiles in routine practice.

The launch of the registry also comes at a time of heightened regulatory focus on how patient registries and RWD can address post-trial evidence gaps and support regulatory decision-making in Alzheimer’s disease. This was reflected in a recent joint HMA–EMA workshop, which brought together regulators and a broad range of stakeholders to examine how registries can better support long-term evidence generation on the safety and effectiveness of Alzheimer’s therapies.