Alzheimer’s Drug Discovery Foundation (ADDF) Announces New Biobank Sharing Program to Accelerate Alzheimer’s Disease Biomarker Research

• ADDF’s Diagnostics Accelerator partners with leading pharmaceutical companies to provide access to valuable patient samples collected from earlier clinical trials to qualified researchers for biomarker development
• ADDF also announces three new research awards, expanding the Diagnostics Accelerator’s investments to almost $16 million across the world

The Alzheimer’s Drug Discovery Foundation (ADDF) has partnered with leading pharmaceutical companies to create one of the largest biobank sharing programs including blood and cerebral spinal fluid specimens from Alzheimer’s disease patients who participated in earlier clinical trials.

These collaborative agreements, including one with Roche (known as Genentech in the United States), one with Shionogi & Co., LTD and Janssen Pharmaceuticals, Inc., and one with Eisai, are part of the ADDF’s Diagnostics Accelerator (DxA). The Diagnostics Accelerator is an initiative supported by a coalition of leading philanthropists, including ADDF co-founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Bezos, and others, dedicated to developing reliable and affordable biomarker tests for early diagnosis of Alzheimer’s disease.

“Our collaborations with each of these companies combine to bridge a significant gap, giving researchers access to thousands of high-quality biological samples that would otherwise take them a great deal of time and money to secure,” said Howard Fillit, M.D., Founding Executive Director and Chief Science Officer of the ADDF. “Not only do we fund research, but this biobank is another way we connect researchers with professionals and companies with a range of resources and expertise that can help advance their research—and advance the entire field—more quickly.”

Access to the samples will be facilitated through the Diagnostics Accelerator. As part of the rigorous scientific due diligence the ADDF’s scientists complete for each DxA proposal, they will also consider which research proposals would benefit from access to the samples and which collection would be the best fit.

The clinical specimens provided through these agreements were collected under informed consent in past clinical trials to allow use of those samples for research purposes. Specimens are from trials that included patients at different stages of Alzheimer’s disease and will be available to researchers developing cutting-edge biomarkers for diagnosis of Alzheimer’s.

To meet the criteria for access to the biobank, researchers must employ an established analytical methodology, including a clear biological rationale for the biomarker and a plan for how the samples will be used. The ADDF will collaborate with company partners to determine which proposals get access to the samples, but the final decision about granting access will rest with each company.

These sample collections come from seven completed phase 2 and 3 trials. All were “gold standard” randomized, double blind and placebo-controlled trials that had precise criteria about which patients were included and how their samples were collected. Every specimen was collected under rigorous clinical trial conditions and is well characterized, meaning researchers will have crucial details about each sample, such as the patient’s age, ethnicity, sex and cognitive test scores.

The trials included through the new program are: EARLY (NCT02569398), sponsored by Janssen Pharmaceuticals, Inc. and Shionogi & Co., LTD; ABBY (NCT 01343966), BLAZE (NCT01397578) and CREAD 1 (NCT02670083) & 2 (NCT03114657), sponsored by Roche; and MissionAD1 (NCT02956486) and MissionAD2 (NCT03036280), sponsored by Eisai.

The Diagnostics Accelerator Also Announces Nearly $3 Million in Additional Research Investments

Three new investments by the ADDF’s Diagnostics Accelerator support tests that measure protein and genetic biomarkers in the blood that indicate the status of neurodegeneration in the brain. With these awards, the DxA has now invested nearly $16 million in 19 research projects around the world in both academic and biotech settings.

• Michael Catania, PhD and his team at Biological Dynamics in San Diego (up to $1,836,770 award) aim to expand applications of their technology to detect Alzheimer’s disease biomarkers embedded in small particles called exosomes that are naturally released from neurons in the brain and then carried into the bloodstream.
• Gregory Penner, PhD at NeoNeuro in France (up to $363,000 award) has developed a potentially revolutionary approach to Alzheimer’s diagnosis using aptamers—small man-made DNA sequences that bind to specific targets in blood to diagnose various stages of Alzheimer’s disease.
• Marta Barrachina, PhD and her team at ADmit Therapeutics in Spain (up to $497,652) aim to develop an Alzheimer’s diagnostic blood test to evaluate DNA modifications they found to be predictive of disease progression and which may represent an early disease indicator.