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Alzheimer's Disease Clinical Trials: Stage, Biomarkers, and Recruiting Studies | TrialFinder
HomeResourcesAlzheimer's Disease Clinical Trials: How Disease Stage and Biomarkers Shape Eligibility

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Published · September 28, 2026

Alzheimer's Disease Clinical Trials: How Disease Stage and Biomarkers Shape Eligibility

Alzheimer's disease is not one trial population. It progresses from mild cognitive impairment (MCI) due to Alzheimer's through mild, moderate, and severe dementia. Trials recruit by stage. Most disease-modifying drug trials enroll only at the early symptomatic stages — MCI or mild dementia — so stage decides which trials a person can join at all.

Many people who open this page are adult children or spouses, not the person with the diagnosis. Most Alzheimer's trials require a study partner, usually a family member, who attends visits and reports on daily function. The notes below are written so a caregiver researching for a parent can use them.

A clinical trial is one option to raise with the treating doctor. It is not automatically better than approved treatment. The useful question is whether a given study matches this stage, biomarker status, and whether a study partner can take part.

Early-stage and advanced Alzheimer's are not interchangeable

Disease stage and biomarker confirmation decide both standard treatment options and which trials fit. A listing written for MCI or mild dementia is not the same as one written for moderate or severe dementia, or as a prevention study for people who do not yet have symptoms.

MCI due to Alzheimer's. Thinking and memory have changed, but daily independence is largely preserved. This is one of the two stages most disease-modifying drug trials use.

Mild dementia. Daily function is affected, still in the early symptomatic window. Together with MCI, this is the group named in most anti-amyloid protocols.

Moderate to severe dementia. Later stages. Disease-modifying drug trials rarely enroll here. Symptomatic studies — cognition, agitation, sleep — and caregiver-support trials are more typical.

Prevention or at-risk. People without symptoms yet, including APOE4 carriers and families with early-onset inherited Alzheimer's. Those lists are a different population from symptomatic disease.

A report that only says "Alzheimer's" or "dementia" is often not enough to judge eligibility. Ask which stage applies.

The plain-language clinical trial glossary can help with terms such as eligibility, phase, and standard of care.

Biomarker testing in plain language

Modern Alzheimer's diagnosis, and most modern trials, no longer rely on symptoms alone. Three routes can look for amyloid and tau biology:

Amyloid and tau PET scans. Imaging that can show amyloid plaques or tau tangles in the brain.

Cerebrospinal fluid (CSF) testing. A lumbar puncture (spinal tap) that measures amyloid and tau proteins in spinal fluid.

Blood tests. Newer plasma tests. The first blood test to aid Alzheimer's diagnosis, measuring pTau217 and amyloid-beta, was cleared by the FDA in May 2025 for adults 55 and older who have symptoms. It is an aid to diagnosis, not a stand-alone yes or no.

Most disease-modifying trials require biomarker confirmation of amyloid pathology before enrollment. A symptoms-only diagnosis may not be enough for those protocols. Availability of PET, CSF, and blood testing varies by clinic and country. The treating doctor can say which route is available and whether a trial would repeat the test.

Anti-amyloid treatment: context, not a recommendation

Two anti-amyloid antibodies are now FDA-approved for early symptomatic Alzheimer's with confirmed amyloid pathology: lecanemab (Leqembi, 2023) and donanemab (Kisunla, 2024).

In plain language, that changed three things. First, there are approved drugs that target amyloid in early disease — they slow decline modestly rather than cure. Second, they carry a risk of ARIA: brain swelling or microbleeds monitored by MRI. ApoE ε4 genetic testing is recommended before starting, because risk is higher in some genotypes. Third, those approvals reshaped the trial pipeline toward earlier intervention, next-generation antibodies, combination approaches, and prevention.

This page does not recommend for or against these drugs. That is a conversation with the treating physician, including whether an approved antibody, a trial, or standard symptomatic care is the relevant path for this person.

The trial list is broader than new anti-amyloid drugs

Recruiting studies are not only next-in-class amyloid antibodies.

Next-generation disease-modifying trials. Other antibodies, tau-targeting approaches, anti-inflammatory studies, and metabolic approaches (including some GLP-1 drugs). These protocols still usually need a stage match and, often, biomarker confirmation.

Symptomatic treatment trials. Studies aimed at cognition, agitation, or sleep, including at later dementia stages where disease-modifying drug trials do not enroll.

Prevention trials. For people at risk before symptoms — for example APOE4 carriers, or families with early-onset inherited Alzheimer's.

Non-drug trials. Lifestyle, cognitive training, and caregiver-support interventions. A caregiver who cannot join a drug study with a parent may still find a support or training trial that names Alzheimer's.

Recruiting Alzheimer's trials

Questions to ask a doctor

A short list is usually enough:

  • Which Alzheimer's stage applies here — MCI, mild dementia, moderate, or severe — and is biomarker testing available?
  • If testing is available, which route fits: amyloid or tau PET, CSF via lumbar puncture, or a blood test?
  • For this stage and biomarker status, is an approved anti-amyloid drug, a trial, or standard symptomatic care the relevant path to discuss?
  • Is ApoE ε4 testing recommended, and how is ARIA risk monitored if an antibody is on the table?
  • What does being a study partner involve — visits, questionnaires, and who can fill that role?
  • For this profile, what is approved or considered standard where I live, and how would a given trial compare?

Want to prepare for the appointment? The guide How to Talk to Your Doctor About Clinical Trials explains how to raise the topic and what to bring with you.

Sources

  • NIA: Alzheimer's disease fact sheet
  • NIA: How Alzheimer's disease is diagnosed
  • FDA: traditional approval of lecanemab (Leqembi), 2023
  • FDA: approval of donanemab (Kisunla), 2024
  • FDA: clearance of the first Alzheimer's blood test, May 2025
  • Recruiting-trial facts on this page come from ClinicalTrials.gov and are shown through TrialFinder listings.

Further reading

How to Talk to Your Doctor About Clinical Trials What questions should you ask your doctor about clinical trials? A step-by-step guide for patients: when to bring it up, what to prepare, and what to do after.

Key Clinical Trial Terms Plain-language explanations of terms patients and families encounter during the clinical trial process.

Start Here: How to Search for Clinical Trials on TrialFinder A step-by-step guide to finding clinical trials on TrialFinder. Learn how to search by condition, use filters, and understand your results.

Before You Join a Clinical Trial: Screening, Informed Consent, and Red Flags What happens between finding a clinical trial and your first visit: screening, the informed consent form, the questions worth asking, common fears answered plainly, and the red flags that should make you walk away.

Clinical Trials in Mental Health: What Patients and Families Should Know Mental health clinical trials can test medications, psychotherapy, TMS devices, digital therapeutics, and psychedelic-assisted treatment. Here is how they differ from cancer trials, and how to start looking.

The Reminder Moderna and Merck's Personalized mRNA Cancer Vaccine Gives Us About Clinical Trials Moderna and Merck's personalized mRNA cancer vaccine just hit its Phase 3 endpoints in melanoma. Here's what it teaches us about the value of joining clinical trials.

Daraxonrasib (RASONQUE) Is Now FDA-Approved for Metastatic Pancreatic Cancer The FDA approved daraxonrasib (RASONQUE) on August 26, 2026 for metastatic pancreatic adenocarcinoma after prior therapy or when multiagent therapy is not an option.

What is a Clinical Trial? (It's More Than You Think) How clinical trials work, why they matter, and what patients should know before considering one.

Not a Perfect Match? Tips for Getting Into a Clinical Trial Anyway A rejection from a clinical trial doesn't have to be the end. Practical tips for patients and caregivers who hit a wall.

How to Talk About Clinical Trials with a Family Member A guide for caregivers on introducing clinical trials to a loved one who is hesitant, tired, or afraid.

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This article was written by a patient advocate based on personal experience, not by a medical professional. It is not medical advice. Consult your doctor before making any medical decisions.

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Trial data from ClinicalTrials.gov. For information only.

This list is limited to recruiting studies whose title or listed conditions name Alzheimer's disease. A stage or approach heading appears only when that term is named in those same fields. Exact biomarker results and study-partner rules are often missing there.

Disease stage

Approach

Loading matching clinical trials

Trials whose title or listed conditions name MCI or mild cognitive impairment

  • OTC Hearing Aid and MCI

    Hearing Loss · Mild Cognitive Impairment · Alzheimer Disease and Related Dementias (ADRD)

    United StatesRecruiting
    Simple summary·Eligibility check·Doctor guide
    Evanston, United States · La Crosse, United States

  • Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline

    Mild Cognitive Impairment · Alzheimer Dementia (AD)

    United StatesRecruiting
    Simple summary·Eligibility check·Doctor guide
    Austin, United States

  • Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)

    Mild Traumatic Brain Injury · Moderate Traumatic Brain Injury · Mild Cognitive Impairment

    United StatesRecruiting
    Simple summary·Eligibility check·Doctor guide
    Boston, United States

  • Autoimmune Features of Neurodegenerative Disorders

    Parkinson Disease · Alzheimer Disease · Mild Cognitive Impairment

    United StatesRecruiting
    Simple summary·Eligibility check·Doctor guide
    New York, United States

  • A Feasiblity Study of Green Activity Program for People Living With Memory Challenges

    Mild Cognitive Impairment · Alzheimer Disease · Subjective Cognitive Decline (SCD)

    United StatesRecruiting
    Simple summary·Eligibility check·Doctor guide
    Bloomington, United States

  • Autophagy-Enhancers to Reduce Sleep Disturbances

    Mild Cognitive Impairment Due to Alzheimer's Disease · Subjective Cognitive Decline (SCD)

    GermanyRecruiting
    Simple summary·Eligibility check·Doctor guide
    Greifswald, Germany

  • Biomarker-based Trial of NPC-1 for Alzheimer's Pathology

    Alzheimer Disease · Mild Cognitive Impairment (MCI) · Subjective Cognitive Decline (SCD)

    United StatesRecruitingPhase 2
    Simple summary·Eligibility check·Doctor guide
    Boston, United States

  • Genetic Studies of Early-onset Dementia

    Dementia, Early Onset · Alzheimer Dementia (AD) · Mild Cognitive Impairment (MCI)

    United StatesRecruiting
    Simple summary·Eligibility check·Doctor guide
    New York, United States

  • The Swedish BioFINDER - Preclinical AD Study

    Alzheimer Disease · Mild Cognitive Impairment · Mild Dementia

    SwedenRecruiting
    Simple summary·Eligibility check·Doctor guide
    Malmö, Sweden

  • Repurposing Siponimod for Alzheimer's Disease

    Alzheimer Disease · Mild Alzheimer Disease · MCI With Increased Risk for Alzheimer Disease

    United StatesRecruitingPhase 2
    Simple summary·Eligibility check·Doctor guide
    Phoenix, United States

  • Validation of a Digital Intervention to Rehabilitate Cognitive Resources

    Mild Cognitive Impairment (MCI) · Subjective Memory Complaint · Dementia Alzheimer Type

    ItalyRecruiting
    Simple summary·Eligibility check·Doctor guide
    Milan, Italy

  • Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease

    Dementia · Alzheimers Disease · Mild Cognitive Impairment Due to Alzheimer's Disease

    United StatesRecruitingPhase 2
    Simple summary·Eligibility check·Doctor guide
    Boston, United States

  • Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

    Major Depressive Disorder · Alzheimer Disease · Mild Cognitive Impairment

    CanadaRecruiting
    Simple summary·Eligibility check·Doctor guide
    Toronto, Canada

  • Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?

    Neuropathology

    FranceRecruiting
    Simple summary·Eligibility check·Doctor guide
    Montpellier, France · Poitiers, France

  • Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab

    Alzheimer Disease · Mild Cognitive Impairment (MCI)

    ChinaRecruiting
    Simple summary·Eligibility check·Doctor guide
    Hangzhou, China

  • Alzheimer's Disease Multinuclear Imaging Neuro-Enhanced Resolution (AD-MINER)

    Alzheimer Disease · Mild Cognitive Impairment Due to Alzheimer's Disease

    ChinaRecruiting
    Simple summary·Eligibility check·Doctor guide
    Beijing, China

  • Remote Sensing for ADRD-Specific Activities Identification in Older Adults

    Alzheimer Disease and Related Dementias (ADRD) · Mild Cognitive Impairment (MCI)

    United StatesRecruiting
    Simple summary·Eligibility check·Doctor guide
    Columbia, United States

  • Understanding Brain Mechanisms Involved in Autobiographical Memory

    Mild Cognitive Impairment · Alzheimer Disease · Memory Loss

    SwitzerlandRecruiting
    Simple summary·Eligibility check·Doctor guide
    Geneva, Switzerland

  • Time Restricted Eating in Alzheimer's Disease

    Mild Cognitive Impairment (MCI)

    United StatesRecruiting
    Simple summary·Eligibility check·Doctor guide
    Phoenix, United States · Phoenix, United States

  • HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population

    Dementia · Mild Cognitive Impairment · Dementia Alzheimers

    SpainRecruiting
    Simple summary·Eligibility check·Doctor guide
    Zaragoza, Spain

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