A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer’s Disease

Conditions

Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer’s Disease (AD)

Brief summary

Time to progression

Detailed description

Change from baseline through Week 216 in: –Clinical Dementia Rating Sum of Boxes –Free and Cued Selective Reminding Testtotal recall score –Digit Symbol Substitution Test score –Cognitive Function Instrumentstudy partner total score –Category fluency total score –Mini-Mental State Examination total score -Logical Memory II Delayed Paragraph Recall score –Amsterdam Instrumental Activities of Daily Living Questionnaire Short Versionstudy partner total score –Trail Making Test, Nature, frequency, severity of adverse events and serious adverse events, Change from baseline in clinical laboratory assessments and vital signs, physical examinations (including neurological systems), ECGs, and Columbia-Suicide Severity Rating Scale (C-SSRS), Nature, frequency, severity, and timing of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) magnetic resonance imaging (MRI) findings, Nature, frequency, severity, and timing of infusion-related reactions (IRRs), Change from baseline through Week 216 in blood biomarkers phosphorylated tau (pTau217), glial fibrillar acidic protein (GFAP)

Related papers

No related papers found yet.

Interventions

DRUGTrontinemab

DRUG[18F]MK-6240

DRUGMatching Trontinemab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to progression	—

Secondary

Measure	Time frame
Change from baseline through Week 216 in: –Clinical Dementia Rating Sum of Boxes –Free and Cued Selective Reminding Testtotal recall score –Digit Symbol Substitution Test score –Cognitive Function Instrumentstudy partner total score –Category fluency total score –Mini-Mental State Examination total score -Logical Memory II Delayed Paragraph Recall score –Amsterdam Instrumental Activities of Daily Living Questionnaire Short Versionstudy partner total score –Trail Making Test, Nature, frequency, severity of adverse events and serious adverse events, Change from baseline in clinical laboratory assessments and vital signs, physical examinations (including neurological systems), ECGs, and Columbia-Suicide Severity Rating Scale (C-SSRS), Nature, frequency, severity, and timing of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) magnetic resonance imaging (MRI) findings, Nature, frequency, severity, and tim	—

Measure

Time frame

Change from baseline through Week 216 in: –Clinical Dementia Rating Sum of Boxes –Free and Cued Selective Reminding Testtotal recall score –Digit Symbol Substitution Test score –Cognitive Function Instrumentstudy partner total score –Category fluency total score –Mini-Mental State Examination total score -Logical Memory II Delayed Paragraph Recall score –Amsterdam Instrumental Activities of Daily Living Questionnaire Short Versionstudy partner total score –Trail Making Test, Nature, frequency, severity of adverse events and serious adverse events, Change from baseline in clinical laboratory assessments and vital signs, physical examinations (including neurological systems), ECGs, and Columbia-Suicide Severity Rating Scale (C-SSRS), Nature, frequency, severity, and timing of amyloid-related imaging abnormalities-edema/effusion (ARIA-E) and amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) magnetic resonance imaging (MRI) findings, Nature, frequency, severity, and tim

—

Outcome results

None listed