2024 ADDF Neuroimaging and CSF Biomarker Program

Eligibility

Funding is open to researchers and clinicians worldwide at:

• Academic medical centers and universities or nonprofits. Industry partnerships are encouraged.
• Biotechnology companies. Existing companies and new startups are both eligible.
• NOTE: Funding is provided through mission-related investments that require return on investment based upon scientific and/or business milestones (refer to the ADDF Research Strategy for more information).

Summary

The ADDF focuses on advancing drug development for Alzheimer’s and related dementias and the biomarker tools that aid in this process. The 2024 ADDF Neuroimaging and CSF Biomarker Program prioritizes biomarker programs that define a specific use and have potential for commercial and clinical translation, with an emphasis on clinical trials (see the Evaluation section below). Funding of up to $600,000 based on stage and scope of research for one year with potential for follow-on funding.

The 2024 ADDF Neuroimaging and CSF Biomarker Program supports advancement of neuroimaging and CSF biomarkers that can do one or more of the following:

1. Demonstrate target engagement for novel therapeutics. Biomarkers that can serve as direct measures of target engagement for novel drugs in clinical development. High priority will be given to projects advancing biomarkers that can be used as specific companion biomarkers for therapies currently in the development pipeline. Identification of such therapies strengthens an application.
2. Detect signs of disease earlier and monitor progression. Programs developing sensitive biomarkers that can detect disease earlier than currently available biomarkers. This includes biomarkers that can predict and monitor conversion from cognitively healthy to mild cognitive impairment (MCI) or MCI to Alzheimer’s disease. We also seek prognostic markers that can predict rates of cognitive decline.
3. More accurately diagnose and distinguish between dementia subtypes. Many types of dementias can present with similar clinical features, and patients often show overlapping pathologies. At present, it is challenging to distinguish between dementia subtypes and proteinopathies. Biomarkers that can distinguish between subtypes and stratify patients in clinical trials are of high priority.

Modality Specific Priorities

Neuroimaging:

• Positron emission tomography (PET): These projects should focus on ligands for target engagement and pharmacodynamic measurements of novel and repurposed therapeutics. This RFP will support pharmacokinetics, safety, synthesis, and clinical development of novel PET ligands. The investigative team should include individuals with experience in developing PET ligands for human use.
• Magnetic resonance imaging (MRI): The proposed structural or functional approach should already have proof-of-concept data in human patients and be translatable for clinical use. Approaches that can measure novel targets and are significant improvements upon what is currently available in MR techniques are of higher priority.
• Magnetic resonance spectroscopy (MRS): The ability to detect specific molecules or proteins relevant to disease or a specific drug in development should be demonstrated in the preliminary data section of the application.

Cerebrospinal fluid (CSF) biomarkers can be a single analyte or panel of analytes; however, the proposed signature should have proof-of-concept data in human patient samples and the specific analyte combination should be well justified.

Functional activity measures applicable to this RFP include electroencephalogram (EEG), magnetoencephalography (MEG), and transcranial magnetic stimulation (TMS). Only highly novel techniques or analyses for EEG, MEG and TMS will be considered. These proposals must meet the following criteria:

• The proposed approach is an improvement on already existing functional measures used in clinical practice for diagnosing and monitoring dementias
• The biomarker and its biological connection to the disease should be established and clearly described
• Proof-of-concept data should be completed in human patients

Other novel approaches: The biomarker should already be identified and validated in at least a small number of human samples.

Application Submission

The application process will be completed in two-stages:

1. Letter of Intent (LOI). Applicants should submit a Letter of Intent (LOI) through the ADDF Funding Portal. An approved LOI is required prior to submission of a full proposal. ADDF’s science team will evaluate LOIs to determine whether the proposed project is consistent with the ADDF's mission and funding priorities. Generally, applicants can expect to be notified within 2-3 weeks of their LOI submission. The deadline for applicants to submit their Letter of Intent to the ADDF is 3:00pm MT, September 29, 2023.

2. Full Proposal. If invited, submit a full proposal through the ADDF Funding Portal. Applicants must obtain institutional approval from the University of Calgary prior to submitting their full proposal to the ADDF.  Initiate required University of Calgary internal approvals by completing a Pre-Award/Application record in RMS (https://my.rms.ucalgary.ca/). Attach a copy of your complete full proposal materials and submit for approvals. Please ensure that you allow time for academic approvals prior to the Research Services Office internal review deadline of 12:00pm MT, November 28, 2023.

Overhead

Not Applicable. Only direct costs are allowed. Please review the ADDF Funding Policies.

Application deadlines

RSO detailed review deadline

RSO final internal review deadline

Program application deadline

Application deadlines

Letter of Intent (LOI) Deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Postdocs, students, and trainees: For fellowships and externally-sponsored research training awards or opportunities, you must complete the Research Funding Application Approval (RFAA) Trainee PDF form, and submit it, along with a complete copy of the application, to Research Services at rsotrainee@ucalgary.ca. Trainees should not use RMS at this time.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via either RMS or the RFAA Trainee form, in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

Additional Resources

Request for Proposals

Application Instructions