A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer’s Disease (AD), Followed by an Open-Label Extension Period

Conditions

Alzheimer’s Disease

Brief summary

Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score

Detailed description

Incidence of treatment-emergent adverse events (TEAEs), Incidence of treatment-emergent serious adverse events (TESAEs), Incidence of TEAEs leading to discontinuation or death, Incidence of Drug-related TEAEs, Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET), Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14), Change from Baseline to Week 56 and Week 80 in Amsterdam-Instrumental Activities of Daily Living (AiADL), Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score, Serum concentrations of bepranemab over the 80- week Double-blind Treatment Period

Related papers

No related papers found yet.

Interventions

DRUGBepranemab

DRUGPlacebo matching and without active substance

DRUGNeuraceq 300 MBq/mL solution for injection

DRUG(18F) GTP1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score	—

Secondary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAEs), Incidence of treatment-emergent serious adverse events (TESAEs), Incidence of TEAEs leading to discontinuation or death, Incidence of Drug-related TEAEs, Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET), Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14), Change from Baseline to Week 56 and Week 80 in Amsterdam-Instrumental Activities of Daily Living (AiADL), Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score, Serum concentrations of bepranemab over the 80- week Double-blind Treatment Period	—

Measure

Time frame

Incidence of treatment-emergent adverse events (TEAEs), Incidence of treatment-emergent serious adverse events (TESAEs), Incidence of TEAEs leading to discontinuation or death, Incidence of Drug-related TEAEs, Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET), Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14), Change from Baseline to Week 56 and Week 80 in Amsterdam-Instrumental Activities of Daily Living (AiADL), Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score, Serum concentrations of bepranemab over the 80- week Double-blind Treatment Period

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Countries

Belgium, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed