LOIs for Neuroimaging and CSF Biomarker Program

The Alzheimer’s Drug Discovery Foundation (ADDF) invites letters of intent for its Neuroimaging and CSF Biomarker Program.

The RFP will support efforts to develop and validate established biomarkers for which there is a clear clinical need in Alzheimer’s disease and related dementias. It prioritizes biomarkers with a defined context of use, a clear advantage over other relevant biomarkers, and a path to commercialization and/or clinical use.

Specifically, the RFP focuses on developing novel PET ligands for clinical trials, supporting novel CSF biomarkers, validating innovative MRI approaches in larger cohorts, and developing novel measures of functional activity such as EEG. Novel biomarkers of neuroinflammation, synaptic integrity, autophagy, and TDP-43 are a high priority. Other target areas of interest include neuronal loss, vascular injury and blood-brain barrier integrity, mitochondria and metabolic function, protein misfolding, oxidative stress, white matter changes, Lewy body dementia, and other novel targets supported by compelling biological rationale and connection to the disease. ADDF has limited interest in CSF measures of amyloid and tau.

Grants of up to $600,000 (direct costs only) will be awarded in support of the advancement of neuroimaging and CSF biomarkers that can do one or more of the following:

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.

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. ADDF also seeks prognostic markers that can predict rates of cognitive decline.

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.

Eligible applicants include researchers and clinicians at academic medical centers, universities, nonprofits, and biotechnology companies worldwide. Existing companies and new startups are also eligible, and industry partnerships are strongly encouraged.

Letters of intent are due May 13, 2024, at 5:00 p.m. ET, and selected applicants will be invited to submit a full proposal by July 22, 2024, at 5:00 p.m. ET.

For complete program details, eligibility criteria, and a link to the application portal, see the Alzheimer's Drug Discovery Foundation website.