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.

Amyloid Removal Trial

A Phase IIIb/IV Open-Label Study of Lecanemab to Evaluate Prevention and Progression of Dominantly Inherited Alzheimer’s Disease

In 2012, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University in St. Louis launched the first secondary prevention trial for Dominantly Inherited Alzheimer’s Disease (DIAD) families. The initial study drug arms, gantenerumab and solanezumab (both amyloid-based therapies) ended late 2019. In mid-2020, the DIAN-TU continued treatment with gantenrumab in an open label extension study (OLE) which ended mid-2023. The DIAN-TU is now planning to launch the Amyloid Removal Trial (ART) with lecanemab, an active anti-amyloid study drug designed to target amyloid plaques. Approved by the FDA in 2023, lecanemab is the first traditionally approved treatment for patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease.

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. Participants will be co-enrolled in the Dominantly Inherited Alzheimer Network Observational (DIAN Obs) natural history study (NCT00869817) through which clinical, cognitive, imaging and fluid biomarker assessments will be conducted.

The main objectives of the 5-year DIAN-TU-003 ART are:

To determine the effects of amyloid removal on age of symptom onset and clinical progression
To determine if amyloid plaque can be fully removed in DIAD
To determine the effects of amyloid removal on biomarkers of disease progression

The DIAN-TU-003 ART is an important study for the field of Alzheimer’s disease with the potential to answer key scientific questions regarding drug dose and duration, mechanism of action, safety, and optimal timing, exposure and effects of treatment to provide the greatest clinical benefit. DIAN-TU-001 OLE participants were treated with the anti-amyloid therapy gantenerumab for 2 to 10 years, representing the longest treated group of patients with amyloid removing antibodies. Findings show that for this group of participants, overall, there was partial but not full amyloid removal. The DIAN-TU-003 ART will enable continued evaluation of the long-term effects of amyloid removal on disease progression in these participants and may provide important information regarding whether removing amyloid plaques can delay, slow, or prevent symptom onset in DIAD.

Click for Enrollment Criteria

Previously participated in the DIAN-TU-001 gantenerumab OLE period.
Willing to participate in ongoing anti-amyloid therapy with informed consent by participant or legally authorized representative.
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).
Co-enrollment in the DIAN Observational Study (DIAN Obs, NCT00869817) and willing to complete DIAN Obs procedures and assessments, DIAN Obs Inclusion Criteria
Able to undergo safety Magnetic Resonance Imaging (MRI) scans as required.
Vascular access adequate for study drug administration and safety monitoring