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 at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

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 / Gantenerumab / Lecanemab / Solanezumab

Listed sites

Recruiting sites

Enrollment

490

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Mini-Mental State Examination (MMSE)

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

Eudract number2013-000307-17

Secondary IDAlzheimer's AssociationHDE 18S84914

Org study IDDIAN-TU-001 (Master)

Other grantGHR FoundationFile 4401

NCT IDNCT01760005

NihR01AG046179

NihR01AG053267

NihR56AG053267

RegistryREec-2014-0817Spanish Clinical Studies Registry

Other grantThe Alzheimer's AssociationDIAN-TU NG-16-434362

NihU01AG042791

NihU01AG059798

Timeline

Milestones

Study start2012-12actual (month precision)

Study first posted2013-01-03estimated

Last update posted2026-02-13actual

Primary completion2028-04estimated (month precision)

Study completion2028-07estimated (month precision)

Assets

Drug assets

E2814 Gantenerumab Lecanemab Solanezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Between 18-80 years of age

•Individuals who know they have an Alzheimer's disease-causing mutation or are unaware of their genetic status and have dominantly inherited Alzheimer's disease (DIAD) mutation in their family.

•Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset. For Cognitive Run-In (CRI): includes participants who are younger than 15 years prior to the expected age of cognitive symptom onset, in addition to those 15 years younger and no more than 10 years older than expected 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, subject 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

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

•Alcohol or drug dependence 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 (1)

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.

Global cognition

1 endpoint

Primary/protocol endpoint

Assess cognitive efficacy in individuals with mutations causing dominantly inherited AD as measured by the change from baseline in the DIAN-Multivariate Cognitive Endpoint (DIAN-MCE)

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

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Publications (15)

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.