Through the Diagnostics Accelerator (DxA), the Alzheimer’s Drug Discovery Foundation (ADDF) has partnered with leading pharmaceutical companies to create one of the largest biobank-sharing programs for specimens from Alzheimer’s patients who participated in earlier clinical trials. Well-characterized samples of serum, plasma, whole blood, and CSF from clinical trials that included patients at different stages of Alzheimer’s disease will be available to select researchers developing and validating biomarkers for the diagnosis of Alzheimer’s disease.
Access to samples will be facilitated through this RFP. To meet the criteria for access to samples, proposals should be in the proof-of-principle or validation stages of development. Submissions must employ an established analytical methodology and include a clear biological rationale for the biomarker and statistical justification for the requested sample numbers.
Proof-of-principle studies should be supported by prior human data justifying that the candidate markers might function as biomarkers that could be used to support clinical trials for Alzheimer’s disease or related dementias.
Validation awards will support the further development of previously identified biomarkers for use in Alzheimer’s disease research.
Proposals must include specific aims and must employ an established analytical methodology, including a clear biological rationale for the biomarker and a plan for how the samples will be used, power analysis, and any statistical details.
Applicants should address how proposed studies would move the biomarker towards the clinic including strategies for regulatory approval and scale-up together with commercialization where appropriate. Proposals should consider compatibility with existing sampling infrastructure, scalability, and intellectual property position. Where available, target biomarkers in peripheral fluids should be compared to quantitative measurements using PET and/or CSF, and outcomes beyond cognition alone.
The ADDF will work to connect highly reviewed proposals with the relevant organization, but the final decision on granting access will rest with each organization.
For interested investigators, please refer to the Diagnostics Accelerator Biobank Sharing RFP.
Proposals requesting funds and samples should apply through the Diagnostics Accelerator Peripheral Biomarker Program and see here for instructions on how to submit a proposal.
“Our collaboration with these companies— Eisai, Janssen, Roche and Shionogi—helps 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”
Gold Standard Samples
Some of the sample collections come from completed phase 2 and 3 trials, and prospective cohort studies. All were “gold standard” randomized, double-blind, and placebo-controlled trials that had precise criteria about how samples were collected, and which patients were included. Every specimen was collected under rigorous clinical trial conditions and is well characterized. Researchers will have crucial details about each sample, such as the patient’s age, ethnicity, sex, and cognitive test scores, as well as if the patient was submitted to a tested compound or placebo, under Data Sharing Agreements. The trials included through the new program are:
- EARLY (sponsored by Janssen and Shionogi)
- ABBY, BLAZE and CREAD 1 & 2 (sponsored by Roche)
- MissionAD1 and MissionAD2 (sponsored by Eisai)
In addition to samples from clinical trials, valuable case-control samples are available to qualified applicants:
- BioFINDER Pilot AD Cohort – Prospective cohort of approx. 50 controls and 50 patients with prodromal AD/AD dementia; subject to a non-negotiable MTA with Biobank Sverige.
More detailed information on these samples can be provided upon request, but applicants are required to first define the specific sample requirements and justification for the proposed study.