The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's disease (AD).
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. Initially, 600 participants will enroll in the double-blind treatment period. Participants in the double-blind treatment period will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion. Following the 52-week main study period, participants will continue participation for up to an additional 76 weeks in an extension period. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Thus, all participants will receive remternetug if they complete the study. An additional 974 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via subcutaneous injection or intravenous infusion. Participants enrolled into the addendum safety cohort are not eligible for the extension period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,667
Administered IV
Administered SC
Administered IV or SC
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Time frame: Week 52
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Time frame: Baseline, Week 52
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
Time frame: Week 24
Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo
Time frame: Baseline, Week 24
Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo
Time frame: Up to Week 52
Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug
Time frame: Baseline to Week 52
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)
Time frame: Baseline to Week 52
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