What is a clinical trial?

A clinical trial is a research study involving human participants designed to evaluate medical interventions — such as drugs, devices, or behavioral strategies. Trials follow a structured protocol and are registered on ClinicalTrials.gov. They progress through phases: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale comparison), and Phase 4 (post-market surveillance).

How do I find clinical trials I'm eligible for?

You can search ClinicalTrials.gov or use ClinicalMetric to filter by condition, phase, or location. Each trial listing includes eligibility criteria such as age range, sex, diagnosis, and prior treatment history. Contact the study team directly or ask your physician to refer you to a relevant trial.

Are clinical trials safe to participate in?

Clinical trials are conducted under strict ethical and regulatory oversight, including IRB approval and FDA regulation in the US. All participants must give informed consent after reviewing potential risks and benefits. Phase 1 trials carry more uncertainty, while Phase 3 trials involve interventions with an established safety profile. Participation is always voluntary and you may withdraw at any time.

What are the phases of clinical trials?

Clinical trials progress through four main phases. Phase 1 tests safety and dosing in a small group (20–80 people). Phase 2 evaluates efficacy and side effects in a larger group (100–300). Phase 3 compares the intervention against standard treatments in thousands of participants. Phase 4 occurs after approval and monitors long-term effects in the general population.

Do participants get paid for joining clinical trials?

Many clinical trials offer compensation for time and travel expenses, though payment structures vary widely by study. Compensation is not intended to be coercive. Some trials also cover treatment costs for participants. Always review the consent form carefully and ask the study coordinator about any financial considerations before enrolling.

Alzheimer's Disease Clinical Trials 2026: Leqembi, Kisunla & What's Next

Medical Notice

This article is for informational purposes only and does not constitute medical advice. Clinical trial eligibility and availability vary. Always consult a qualified healthcare professional before making any medical decisions or considering participation in a clinical trial.

Summary

2023–2024 marked the first FDA approvals of disease-modifying Alzheimer's drugs in history (lecanemab/Leqembi and donanemab/Kisunla). In 2026, research is expanding rapidly: subcutaneous formulations, combination therapies, GLP-1 trials for cognitive protection, and prevention trials in people with genetic risk but no symptoms yet. Understanding what's available — and what's coming — is critical for patients and families navigating this landscape.

The First Disease-Modifying Treatments

For decades, Alzheimer's treatments only addressed symptoms. Lecanemab (Leqembi, Eisai/Biogen) and donanemab (Kisunla, Eli Lilly) are anti-amyloid antibodies — they clear amyloid-beta plaques from the brain, the protein aggregates that accumulate decades before symptoms appear. Both drugs showed statistically significant slowing of cognitive decline (approximately 35%) compared to placebo in large Phase 3 trials.

Both drugs carry a risk of ARIA (amyloid-related imaging abnormalities) — brain swelling or microbleeds detected on MRI. ARIA is usually asymptomatic but can be serious. Risk is higher in APOE4 carriers (the most common genetic risk factor for Alzheimer's). Regular MRI monitoring is required during treatment.

What's in Trials Now (2026)

Subcutaneous lecanemab: Intravenous biweekly infusions are burdensome for patients. Eisai is running trials of a subcutaneous auto-injector formulation that patients can self-administer at home. Phase 3 results are expected in 2026.

Tau-targeting therapies: While amyloid drives early Alzheimer's pathology, tau tangles correlate more closely with neurodegeneration and cognitive symptoms. Anti-tau antibodies (semorinemab, zagotenemab) and tau aggregation inhibitors are in Phase 2/3 trials. Combination amyloid + tau approaches are being explored.

GLP-1 trials for Alzheimer's: The EVOKE and EVOKE+ trials tested oral semaglutide vs. placebo in early Alzheimer's. Results showed a non-significant trend — but interest in GLP-1 mechanisms in the brain has accelerated substantially. GLP-1 receptors are expressed on neurons and microglia; GLP-1 drugs reduce neuroinflammation and have neuroprotective effects in animal models. Multiple follow-on trials are now recruiting.

Prevention trials (AHEAD 3-45): The AHEAD study is testing lecanemab in cognitively normal older adults with intermediate or elevated amyloid — people who are "pre-Alzheimer's" by biomarker but symptom-free. This represents a fundamental shift: treating the disease before it causes cognitive damage.

Next-generation anti-amyloid: Remternetug (Eli Lilly) is an anti-amyloid antibody with a different binding profile designed for faster plaque clearance and potentially lower ARIA risk. Phase 3 is enrolling.

Who Qualifies for Alzheimer's Trials?

Eligibility depends heavily on disease stage and biomarker status:

Treatment trials (Leqembi/Kisunla-type): Mild cognitive impairment (MCI) or mild dementia due to Alzheimer's; confirmed amyloid pathology via PET scan or CSF testing; CDR (Clinical Dementia Rating) 0.5 or 1
Prevention trials: Cognitively normal; age typically 55–80; elevated or intermediate amyloid on PET; APOE4 carriers are often prioritized
Tau trials: Typically target more moderate Alzheimer's (CDR 1–2) where tau pathology is more prominent

APOE genotyping is often part of the screening process. APOE4 homozygotes (two copies) face higher ARIA risk and may be excluded from some trials or require more intensive monitoring.

Accessing Alzheimer's Trials

The Alzheimer's Association Trial Match (alz.org/trialmatch) is a dedicated matching service. The Banner Alzheimer's Institute, Mayo Clinic, and most major academic medical centers run Alzheimer's research programs. Genetic testing through programs like the Alzheimer's Prevention Registry can help identify at-risk individuals eligible for prevention trials.

ClinicalMetric allows you to search all currently recruiting Alzheimer's trials directly — filter by "Alzheimer" or "dementia" to see open studies near you.