The goal of the primary prevention trial is to intervene in the disease process before too much permanent damage is done.
What is a secondary prevention trial?
Secondary prevention trials are studies aimed at stopping a disease from getting worse or causing further harm once it has already been detected. These trials usually involve people who already have early signs of a disease or are at high risk for developing it. In the context of Alzheimer’s disease (AD), these trials target AD pathology in asymptomatic or mild symptomatic individuals. While changes in the brain have begun at this point, “secondary prevention” efforts seek to intervene in the disease process before too much permanent damage is done.
The following studies focus on individuals who have a genetic likelihood to develop dominantly inherited Alzheimer’s disease (DIAD) at a young age, typically in their 30s, 40s, or 50s. Although there are differences between DIAD and the more common age-associated sporadic Alzheimer’s disease, the results of this study may have implications for future studies and treatments in sporadic Alzheimer’s disease.
Current trials
Secondary Prevention: DIAN-TU-001
Prevention efforts target amyloid beta (Aβ) in individuals after amyloid plaques are present in the brain.
Secondary Prevention: DIAN-TU-003
The DIAN-TU-003 ART is an open-label study to treat DIAD mutation carrier participants from the DIAN–TU-001 gantenerumab OLE period with lecanemab for a minimum of 5 years.
- Between 18-80 years of age.
- Are known to carry a mutation that causes Alzheimer’s disease (or are willing to learn genetic status before enrollment).
- Are within -10 to +10 years of the predicted age of onset or are already experiencing AD symptoms.
- 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.
- 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 participant’s cognitive and functional abilities, and who agrees to provide information at the study visits that requires input from the study partner.
DIAN-TU Support
Randall Bateman, MD
Principal Investigator & Program Director
- Phone: 314-286-1674
- Email: batemanr@wustl.edu
Study Team | Funding | History
Study details (DIAN-TU-001) on clinicaltrials.gov
For Investigators
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