A randomized, placebo-controlled, parallel group, 72-week study to evaluate the efficacy and safety of VHB937 in participants with early Alzheimer’s Disease followed by an Extension

Conditions

Alzheimer’s disease

Brief summary

Change from Baseline to Week 72 in the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB)

Detailed description

Incidence and severity of: ● Adverse events ● Safety findings from brain MRI (based on blinded independent central reading to assess abnormalities including ARIA events) ● Laboratory tests ● Vital signs ● ECG findings ● Suicidality assessment (Columbia Suicide Severity Rating Scale C-SSRS), Changes from Baseline in CDR-SB and ADAS-Cog14 over time until Week 72, Changes from Baseline in instrumental activities of daily living (iADL) on the ADCS-ADL scale over time until Week 72, Pharmacokinetics: determination of VHB937 concentrations in serum at selected timepoints Immunogenicity: determination of anti-VHB937 antibodies in serum at selected timepoints

Related papers

No related papers found yet.

Interventions

DRUG00 mg/mL Concentrate for solution for infusion

DRUGVHB937

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Incidence and severity of: ● Adverse events ● Safety findings from brain MRI (based on blinded independent central reading to assess abnormalities including ARIA events) ● Laboratory tests ● Vital signs ● ECG findings ● Suicidality assessment (Columbia Suicide Severity Rating Scale C-SSRS), Changes from Baseline in CDR-SB and ADAS-Cog14 over time until Week 72, Changes from Baseline in instrumental activities of daily living (iADL) on the ADCS-ADL scale over time until Week 72, Pharmacokinetics: determination of VHB937 concentrations in serum at selected timepoints Immunogenicity: determination of anti-VHB937 antibodies in serum at selected timepoints	—

Measure

Time frame

Incidence and severity of: ● Adverse events ● Safety findings from brain MRI (based on blinded independent central reading to assess abnormalities including ARIA events) ● Laboratory tests ● Vital signs ● ECG findings ● Suicidality assessment (Columbia Suicide Severity Rating Scale C-SSRS), Changes from Baseline in CDR-SB and ADAS-Cog14 over time until Week 72, Changes from Baseline in instrumental activities of daily living (iADL) on the ADCS-ADL scale over time until Week 72, Pharmacokinetics: determination of VHB937 concentrations in serum at selected timepoints Immunogenicity: determination of anti-VHB937 antibodies in serum at selected timepoints

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Primary

Measure	Time frame
Change from Baseline to Week 72 in the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB)	—

Countries

Czechia, France, Germany, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed