Active Clinical Trial

Expanding the ADLD ASO Trial

From a single patient to a multi-patient program. A $925,000 leadership gift to Mayo Clinic unlocks the next phase of ADLD treatment.

First-in-Human Underway

n=1 trial active at Mayo Clinic

Mayo Clinic Lead

RNA Therapeutics Discovery Program

n-Lorem Foundation Partner

Individualized ASO development

Where We Are

A historic first in ADLD

For patients living with adult-onset autosomal dominant leukodystrophy, no disease-modifying treatments have ever been approved or formally studied in clinical care. ADLD progresses slowly but relentlessly, often over more than a decade, ultimately leading to death.

That changed when Mayo Clinic, in collaboration with the n-Lorem Foundation, developed a first-of-its-kind antisense oligonucleotide (ASO) therapy targeting the root cause of ADLD: overexpression of the LMNB1 gene. ASOs have already proven successful in genetic and neurologic disorders including spinal muscular atrophy, ALS, and Duchenne muscular dystrophy.

Our single-patient trial at Mayo has shown signs that the therapy may be safely reducing disease-related damage. The patient has tolerated multiple doses well, with initial decreases in markers of neurodegeneration.

The Path Forward

Five years to scale a working therapy

Years 1–2

Multi-Patient Enrollment

Up to five participants enrolled in a clinical trial targeting the known disease mechanism. Each patient is treated and monitored over two years.

Years 3–4

Refine and Expand

Expand enrollment, refine biomarkers from the Natural History Study, and strengthen the multi-patient dataset that anchors regulatory engagement.

Year 5

Regulatory Path

Prepare for regulatory review and grow durable program infrastructure so this platform can serve future ADLD therapies and other rare diseases.

The Investment

$925,000 over five years

Mayo Clinic requests a leadership gift of $925,000, payable over five years, to build and scale this program from one patient to a regulator-ready multi-patient trial.

Cost Breakdown

5-Year Program

Trial Management and Oversight

Clinical trial coordination, regulatory affairs, monitoring

$250,000

Participant Costs

$100,000 per patient over two years; covers dosing, imaging, lab work, and follow-up for up to five participants

$500,000

Program Infrastructure

Principal investigator, research and clinical operations, data management and reporting

$175,000

Total Leadership Gift

$925,000

Why This Matters

Beyond the first patient

Generate the data regulators need

Multi-patient data gives the FDA the evidence needed to consider expanded access, IND filings, and a path to approval.

Build a reusable trial platform

Mayo Clinic gains an established ASO trial infrastructure that can be adapted for future ADLD therapies (shRNA, repurposed drugs) and other rare diseases.

Unlock additional funding

A funded multi-patient program de-risks the science and positions ADLD for grants, biotech partnerships, and additional philanthropy that single-patient trials cannot attract.

Move every patient forward

A successful trial platform creates a path for every ADLD patient who has been waiting for a treatment, not just the first.

Fund the Expansion

Donate to the ASO Trial

Every dollar goes directly to Mayo Clinic's ASO trial program. 100% to science, no overhead.

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