DIAN-TU

Active not recruitingPhase 2 / PHASE3

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

Lead sponsor

Washington University School of Medicine

Assets

E2814 / Lecanemab

Listed sites

Recruiting sites

Enrollment

197

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Primary end point is the change from Week 24

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDIAN-TU-001 (E2814)

NCT IDNCT05269394

NihR01AG068319

Secondary IDThe Alzheimer's AssociationDIAN-TU OLE-21725093

Timeline

Milestones

Study start2021-12-22actual

Study first posted2022-03-08actual

Last update posted2026-02-13actual

Primary completion2028-04estimated (month precision)

Study completion2028-07estimated (month precision)

Assets

Drug assets

E2814 Lecanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion Criteria:

•Between 18-80 years of age

•Individuals who know they have an Alzheimer's disease-causing mutation.

•Are within -10 to + 10 years of the predicted or actual age of cognitive symptom onset.

•Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive)

•Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning

•Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.

•For women of childbearing potential, if partner is not sterilized, participant must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide).

•Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.

•Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion

Exclusion criteria

•Significant neurologic disease (other than AD) or psychiatric disease that may currently or during the course of the study affect cognition or participant's ability to complete the study.

•At high risk for suicide, e.g., significant suicidal ideation or attempt within last 12 months. Current stable mild depression or current use of antidepressant medications is not exclusionary.

•History or presence of brain MRI scans indicative of any other significant abnormality

•Substance or alcohol use disorder currently or within the past 1 year

•Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan.

•History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders

•Anticoagulants except low dose (≤ 325 mg) aspirin.

•Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months.

•History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.

•Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.

•Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Tau biomarkers

Global cognition

Neurodegeneration biomarkers

Amyloid biomarkers

Global cognition

2 endpoints

Secondary/protocol endpoint

Symptomatic Population (Cohort 1): Key Secondary: Change from Week 24 to Week 208 in Clinical Dementia Scale - Sum of Boxes (CDR-SB).

Time frame:Weeks 24, 52, 104, 156 and 208

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

Symptomatic Population (Cohort 1): Change from Week 24 to Week 104 and Week 208 in the cognitive composite score

Time frame:Weeks 24, 52, 76, 104, 128, 156, 180 and 208

descriptive

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Symptomatic Population (Cohort 1): Change from Week 0 to Week 24 in amyloid PET

Time frame:Week 0 to Week 24

descriptive

Tau biomarkers

3 endpoints

Primary/protocol endpoint

The primary end point is the change from Week 24 to Week 104 and Week 208 in tau PET in the Symptomatic Population (Cohort 1).

Time frame:Weeks 24, 104, and 208

descriptive

Secondary/protocol endpoint

Asymptomatic Population (Cohort 2): Key Secondary: Change from Week 0 to Week 104 and Week 208 in CSF ptau217/total tau

Time frame:Weeks 0, 104 and 208

Phosphorylated tau 217 (p-tau217)

descriptive

Secondary/protocol endpoint

Asymptomatic Population (Cohort 2): Change from Week 0 to Week 52 in CSF ptau217/total tau

Time frame:Week 0 to Week 52

Phosphorylated tau 217 (p-tau217)

descriptive

Neurodegeneration biomarkers

2 endpoints

Secondary/protocol endpoint

Symptomatic population (Cohort 1): Change from Week 24 to Week 104 and Week 208 in CSF neurofilament light chain (NfL)

Time frame:Weeks 24, 104 and 208

Neurofilament light (NfL)

descriptive

Secondary/protocol endpoint

Asymptomatic Population (Cohort 2): Change from Week 52 to Week 104 and Week 208 in CSF neurofilament light chain (NfL)

Time frame:Weeks 52, 104 and 208

Neurofilament light (NfL)

descriptive

Publications (12)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.