The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo. Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,400
Administered SC
Administered SC
Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR)
Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).
Time frame: Baseline to Time to Event up to Week 255
Change from Baseline in Clinical Dementia Rate Box Score (SB)
Change from baseline in Clinical Dementia Rate Box Score (SB) scores range from 0 to 18, with higher scores indicative of more impairment.
Time frame: Baseline, Week 255
Change from Baseline in Montreal Cognitive Assessment (MoCA)
Change from baseline in Montreal Cognitive Assessment (MoCA). Total MoCA score is 0 to 30, with lower scores indicating greater level of impairment.
Time frame: Baseline, Week 255
Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory
Change from baseline in the Category Fluency - Language, Executive Function, Semantic Memory. The total score reflects the sum of correct responses generated across all categories presented, with higher values indicating better performance.
Time frame: Baseline, Week 255
Change from Baseline in the Continuous Paired Associate Learning (CPAL)
Change from baseline in Continuous Paired Associate Learning (CPAL) - Visual episodic memory.
Time frame: Baseline, Week 255
Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem
Change from baseline in the International Shopping List Test (ISLT) - verbal episodic memory.
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Parkway Medical Center
Birmingham, Alabama, United States
MD First Research - Chandler
Chandler, Arizona, United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Alzheimer's Institute Tucson
Tucson, Arizona, United States
Neuro-Pain Medical Center
Fresno, California, United States
Care Access - Huntington Beach
Huntington Beach, California, United States
Inglewood Clinical
Inglewood, California, United States
Irvine Clinical Research
Irvine, California, United States
Healthy Brain Clinic
Long Beach, California, United States
...and 252 more locations
Time frame: Baseline, Week 255
Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory
Change from baseline in the International Daily Symbol Substitution Test-Medicines (iDSSTm) - complex attention memory.
Time frame: Baseline, Week 255
Change from Baseline in Cognitive Function Index (CFI)
Change from baseline in the Cognitive Function Index (CFI).
Time frame: Baseline, Week 255
Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C)
Change from baseline in the Mild Behavioral Impairment Checklist (MBI-C) The MBI-C total score range is 0 to 102, with higher scores indicating greater impairment.
Time frame: Baseline, Week 255
Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI)
Change from baseline in the Activities of Daily Living - Prevention Instrument total scores range from 0 to 54, with higher scores indicating better performance.
Time frame: Baseline, Week 255
Pharmacokinetics: Serum Concentrations of Remternetug
PK: serum concentration of remternetug.
Time frame: Baseline through Week 255
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)
Number of participants with treatment emergent anti-drug antibodies (TE-ADAs).
Time frame: Baseline through Week 255