Primary Prevention Trial | Dominantly Inherited Alzheimer Network

The goal of the primary prevention trial is to intervene before amyloid plaques form in the brain.

What is a primary prevention trial?

There is now clear evidence that the development and progressive accumulation of amyloid beta (Aβ) pathology occurs years before dementia symptoms begin, thereby providing a window of opportunity for intervention prior to symptom onset. Ideally, effective disease-modifying treatments would be started before any irreversible neuronal loss or dysfunction develops. We call this effort “primary prevention”, as the intervention point takes place before amyloid plaques form in the brain.

Current trial

Primary prevention trial: DIAN-TU-002

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled, Two-Stage Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer’s Disease.

The DIAN-TU Primary Prevention placebo-controlled trial will be a first of its kind, targeting amyloid deposition in subjects at risk for DIAD prior to onset of significant amyloid beta (Aß) pathology. Current trials in asymptomatic individuals target Aß after pathology is established; these secondary prevention efforts are likely more effective than treating at later, more advanced stages, however the most effective approach is to prevent AD pathology from forming.

In this study, we will test if it is possible to prevent Aß deposition in DIAD mutation carriers and if doing so will prevent the cascade of pathology associated with AD and, ultimately, dementia in a population that is otherwise certain to get the disease. The DIAN-TU plans to launch the Primary Prevention trial in 2021.

Click for Enrollment Criteria

18 or older
Are known to carry a mutation that causes Alzheimer’s disease (or are willing to learn genetic status before enrollment)
Are within -11 to -25 years of the predicted age of onset (based on parent’s actual age at onset) or are already experiencing AD symptoms
Cognitively normal, Clinical Dementia Rating (CDR) of 0
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 people 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, and who agrees to provide information at the study visits that require informant input for scale completion