Significant neurological disease affecting the central nervous system (CNS) other than AD, that may affect cognition or ability to complete the study.Women not of childbearing potential (WNOCBP) may participate in this trial.Males and females will be eligible for this study.Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.Has an amyloid PET scan result consistent with the presence of brain amyloid pathology. Has a P-tau result consistent with the presence of amyloid pathology.A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening.Gradual and progressive change in cognitive function ≥6 months prior to screening.Participants enrolled into the addendum safety cohort are not eligible for the extension period. The participants will be administered open label remternetug via subcutaneous injection or intravenous infusion. Thus, all participants will receive remternetug if they complete the study.Īn additional 640 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Participants in the double-blind treatment period will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion.įollowing the 52-week main study period, participants will continue participation for up to an additional 52 weeks in an extension period. Initially, 600 participants will enrollin the double-blind treatment period. TRAILRUNNER-ALZ 1 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of remternetug in participants with early symptomatic AD. Why Should I Register and Submit Results?.
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