A Study to Learn About the Safety of Diranersen (BIIB080) Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
416actual
Sites
138
Countries
Australia, Belgium, Canada +14
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-24 | actual | When the study began enrolling |
| Primary completion | 2026-03-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-06-06 | estimated | The whole study's end, after follow-up |
| First posted | 2022-06-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Mild Cognitive Impairment Due to Alzheimer's Disease
- Alzheimer's Disease Dementia
Interventions
- Drug: Diranersen — also filed as ISIS 814907, BIIB080
- Drug: Diranersen-matching placebo
Primary outcome
what the primary-completion date above is the date OFDose response in Change From Baseline to Week 76 on the CDR-SB
measured Baseline to Week 76
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