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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alzheimers Disease, Dementia, Alzheimers Disease, Familial

In brief

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

Key facts

Study ID

NCT01760005

Run by

Washington University School of Medicine

People needed

490

Starts

2012-12-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama in Birmingham — Birmingham, Alabama, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• USC Keck School of Medicine — Los Angeles, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Butler Hospital — Providence, Rhode Island, United States
• Kerwin Medical Center — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States
• Instituto de Investigaciones Neurologicas Raul Carrea, FLENI — Ciudad Autonoma de Buenos Aire, Argentina
• Neuroscience Research Australia — Randwick, New South Wales, Australia
• Alzheimer's Research Australia — Melbourne, Victoria, Australia
• The McCuster Foundation of Alzheimer's Disease Research — Nedlands, Western Australia, Australia
• Hospital das Clínicas da Faculdade de Medicina da USP — São Paulo, Brazil
• UBC Hospital — Vancouver, British Columbia, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• McGill Center for Studies in Aging — Verdun, Quebec, Canada
• CHU de Quebec - Hôpital de l' Enfant Jésus — Québec, Canada
• Grupo de Neurociencias Sede de la Universidad de Antioquia — Medellín, Colombia
• CHU de Toulouse - Hôpital Purpan — Toulouse, Haute Garonne, France
• Hopital Roger Salengro - CHU Lille — Lille, Nord, France
• Groupe Hospitalier Pitie-Salpetriere — Paris, Paris, France

Full record on ClinicalTrials.gov

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