Long-term use of BIIB037 (aducanumab) can prevent progression of Alzheimer’s in patients at early stages of the disease, according to results from the PRIME study.
The clinical effects of 24 and 36 months treatment with aducanumab will be presented in two studies, “Aducanumab titration dosing regimen: 24-month analysis from PRIME, a randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease” and “Aducanumab 36-month data from PRIME: a randomized, double-blind, placebo- controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease.”
The PRIME trial (NCT01677572) is an ongoing Phase 1b study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics (i.e., the interactions between the body and a compound) of aducanumab in 197 participants, aged 50-90, who had clinical manifestations consistent with prodromal (early) or mild Alzheimer’s disease.
Patients were randomized to receive 3, 6, or 10 mg/kg fixed or adjusted doses of either aducanumab or placebo.
Both patients treated with fixed or adjusted doses of aducanumab had a significant reduction in the levels of amyloid plaques in the brain – the hallmark of Alzheimer’s disease.
This reduction also was observed in patients who initially were in the placebo group and later switched to aducanumab. Importantly, patients treated with the highest dose for up to 36 months achieved amyloid plaque reductions to levels below the point that allows their detection in scans.
Positive data concerning patients’ cognitive and physical function, determined by the Clinical Dementia Rating sum of boxes (CDR-SB) and the Mini-Mental State Examination (MMSE) tests, also suggested benefit of long-term use of aducanumab.
No new cases of brain swallowing due to amyloid-related abnormalities (ARIA-E) were reported in patients treated with a fixed dose of the investigative drug, during 24 and 36 months of follow-up. Also, only four patients experienced more than one ARIA-E episode during the initial 24 months.
Collectively, these results support further development of aducanumab in more clinical trials.
Biogen is currently recruiting participants for its two Phase 3 trials, ENGAGE (NCT02477800) and EMERGE (NCT02484547), evaluating the effectiveness and safety of aducanumab in early Alzheimer’s disease.
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