The DIAN-TU platform revolutionizes Alzheimer’s disease trials by enabling simultaneous testing of multiple treatments from industry partners and enhancing trial efficiency through the use of pooled placebo groups.
Our key impacts on Alzheimer’s research
- Launched the world’s first prevention trial for inherited Alzheimer’s disease (DIAD).
- Pioneered an adaptive platform trial model that is now used as a model for other diseases, including ALS.
- Demonstrated that an investigational drug could positively impact the biomarkers of Alzheimer’s in DIAD participants.
- Advanced the field toward primary prevention, aiming to stop the disease process before symptoms can even start.
- Established a dedicated cohort of participants through continuous re-enrollment opportunities, resulting in the longest-studied group in the world to receive anti-amyloid antibodies in a prevention study.
A timeline of DIAN-TU accomplishments
The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) launched the world’s first-ever prevention trial for Dominantly Inherited Alzheimer’s Disease (DIAD). This innovative platform trial was designed to test multiple potential treatments at once, starting with two investigational drugs, gantenerumab and solanezumab. The goal has always been to find therapies that can change the course of the disease.
In 2017, a third drug (atabecestat) was added to the platform trial. to the DIAN-TU platform trial. In 2018, following ongoing safety monitoring and collaborative discussions with the study’s pharmaceutical partner, this arm was discontinued. The decision reflected a careful evaluation of emerging data and underscored an unwavering commitment to participant safety and the integrity of the trial process.
Analyses of data from the first two drugs revealed a significant finding: gantenerumab had a positive impact on the biological markers of the disease. This success led to an Open Label Extension (OLE) study, where participants could continue receiving the treatment to further understand its long-term effects.
Building on this success, the DIAN-TU launched the Tau Next Generation (NexGen) prevention trial. Alzheimer’s disease is characterized by two key proteins: amyloid and tau. This new study arm was the first to test a drug (E2814) designed to target tau tangles, while participants also received an active anti-amyloid drug (lecanemab) designed to target amyloid plaques.
The exciting results from the gantenerumab OLE study directly informed next steps. In 2024, the DIAN-TU launched the DIAN-TU-003 Amyloid Removal Trial (ART). This trial uses the drug lecanemab for participants from the OLE study, building upon the knowledge that targeting amyloid can impact the disease. This shows how each trial provides a crucial stepping stone to the next.
In a landmark achievement for the field, the DIAN-TU-002 Primary Prevention trial enrolled its first participant using the drug remternetug. This is one of the first trials of its kind. Its goal is to stop or significantly delay the very first biological changes of AD, even before a person would be expected to have symptoms. This represents a monumental shift from treatment to true prevention.
