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  ["project_title"]=>
  string(108) "The effect of cerebral comorbidities with bapineuzumab treatment on clinical, biomarker, and safety outcomes"
  ["project_narrative_summary"]=>
  string(682) "Patients with Alzheimer’s disease often have comorbidities of cerebrovascular disease and/or cerebral amyloid angiopathy. While people with severe disease are excluded from trials and clinical therapy, the impact of mild to moderate disease on clinical, biomarker, and safety outcomes remains unknown. This project aims to assess how clinical and imaging measures of cerebrovascular disease and cerebral amyloid angiopathy may alter clinical, biomarker, and safety outcomes across cognitive tests, amyloid measures, and neuroimaging measures, respectively. Results will provide additional safety information about bapineuzumab, and by extension, to newer anti-amyloid medications."
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    ["first_name"]=>
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    ["last_name"]=>
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    ["degree"]=>
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    ["primary_affiliation"]=>
    string(29) "University of New South Wales"
    ["email"]=>
    string(21) "d.jakabek@unsw.edu.au"
    ["state_or_province"]=>
    string(3) "NSW"
    ["country"]=>
    string(9) "Australia"
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      ["p_pers_l_name"]=>
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      ["p_pers_degree"]=>
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      ["p_pers_pr_affil"]=>
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      ["requires_data_access"]=>
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1001) "Background: Clinical use of anti-amyloid monoclonal antibodies is not recommended in people with severe cerebrovascular comorbidities or evidence of cerebral amyloid angiopathy. However, the effects of mild to moderate comorbidities on clinical, biomarker, or safety outcomes has received less attention.

Objective: Determine whether the treatment effect of bapineuzumab on clinical, biomarker, and outcomes is modified by baseline cerebrovascular risk factors, white matter disease, or microhemorrhage burden.

Study design: Secondary analyses of two phase 3 trials of bapineuzumab.

Participants: Participants with Alzheimer’s disease in all study arms.

Primary outcome measure: Change from baseline to final follow-up of 1) cognitive test scores, 2) CSF and PET measures of amyloid, and 2) safety MRI measures of microhaemorrhages, vasogenic oedema, and brain volume.

Statistical analyses: Logistic regression or mixed models for repeated measures as appropriate."
  ["project_brief_bg"]=>
  string(1799) "Although anti-amyloid therapy is available in many regions for Alzheimer’s disease, there is often a restriction of use to people without severe cerebrovascular small vessel disease (operationalised as white matter hyperintensities (WMH)) and/or to people without cerebral amyloid angiopathy (defined as 5 or more microhaemorrhages on screening MRI). Reasons for these exclusions are to exclude participants with alternative causes of cognitive impairment (e.g., vascular dementia) or to exclude participants with pathology that may increase the risk of side effects (e.g., cerebral amyloid angiopathy), respectively.

However, not all WMH and microhemorrhages are equal. Recent large meta-analyses suggest that posterior WMH may be more related to Alzheimer’s disease directly, whereas frontal WMH may be more due to vascular risk factors (Biesbroek et al., 2024). Thus, excluding all severe WMH may inappropriately exclude participants with Alzheimer’s disease related WMH. Similarly, deep microhemorrhages may not represent cerebral amyloid angiopathy (Charidimou et al., 2022) however total microhemorrhage count, rather than distinctions between deep and cortical/lobar locations, are reported in safety information (Ketter et al., 2017). Moreover, there is minimal literature on how clinical cerebrovascular risk factors, or mild-to-moderate levels of either WMH or microhaemorrhage burden, may relate to clinical or biomarker outcomes.

This project aims to determine the associations between cerebrovascular comorbidities, WMH and microhaemorrhage burden with clinical, biomarker, and safety outcomes in bapineuzumab treatment. Findings will provide additional safety and clinical information about bapineuzumab, and by extension, to newer anti-amyloid medications.

"
  ["project_specific_aims"]=>
  string(899) "Aim: Determine the effect of cerebrovascular comorbidities with bapineuzumab treatment on clinical, biomarker, and safety outcomes.

Objectives: Assess whether bapineuzumab treatment effect is modified by the baseline severity of cerebrovascular disease (using clinical criteria, and MRI measures of WMH and microhaemorrhages) on outcomes across clinical (MMSE, ADASCog, CDR-SB), biomarker (amyloid PET and CSF), and safety (amyloid-related imaging abnormalities and brain volumes) measures.

Hypotheses:

1.	Higher baseline cerebrovascular risk is associated with no change in treatment effect on cognitive and biomarker outcomes

2.	Evidence of cerebral amyloid angiopathy is associated with poorer safety outcomes

3.	Microhemorrhages in brain regions not associated with cerebral amyloid angiopathy have no effect on cognitive, biomarker, or safety outcomes

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      ["label"]=>
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      ["value"]=>
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      ["label"]=>
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    }
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  ["project_research_methods"]=>
  string(221) "Patient-level data is sought from NCT00574132 and NCT00575055 which will be pooled across all placebo and treatment arms.

All participants will be included; no additional exclusion criteria will be applied.

"
  ["project_main_outcome_measure"]=>
  string(236) "Incidence of oedema and/or haemorrhage at any timepoint during the study based on central reports

Existing brain volumetric measurements

Scores on CDR, MMSE, and ADAS-Cog tests



No secondary outcome measures."
  ["project_main_predictor_indep"]=>
  string(332) "Clinical cerebrovascular risk factors will be determined based on baseline reported past medical history, concomitant medications, and questionnaires (Hachinski Ischemic Index).

The severity grading and distribution of both white matter hyperintensities and microhaemorrhage will be extracted from existing MRI reads.

"
  ["project_other_variables_interest"]=>
  string(126) "All analyses will include covariate of age.

APOE4 status and bapineuzumab dose required to characterise groups.

"
  ["project_stat_analysis_plan"]=>
  string(590) "Separate logistic regression models will be constructed to assess the effect of baseline WMH or microhaemorrhage burden/distribution, interacting with bapineuzumab treatment, on the risk of developing either oedema or haemorrhage.

Separate mixed models for repeated measures will be constructed to assess the effect of WMH or microhaemorrhage burden/distribution, interacting with bapineuzumab treatment, on brain volume and cognitive outcomes.

Sensitivity analyses will be performed to account for those with CSF and/or PET evidence of amyloid positivity at baseline.

"
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      ["label"]=>
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      ["label"]=>
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  ["project_timeline"]=>
  string(169) "December 2025 - March 2026: Conduct data processing and analyses

March - November 2026: Manuscript preparation, submission, and reporting to YODA Project.

"
  ["project_dissemination_plan"]=>
  string(156) "Submissions to scientific conferences (e.g., AAIC or CTAD) and/or neurology scientific journals (e.g., Neurology, Alzheimer's and Dementia).



"
  ["project_bibliography"]=>
  string(1556) "
Neuroimaging, I., Barkhof, F., Barnes, J., Benke, T., Chen, C., Dal-Bianco, P., Dewenter, A., Duering, M., Enzinger, C., Ewers, M., Exalto, L. G., Franzmeier, N., Hilal, S., Hofer, E.,…Biessels, G. J. (2024). Amyloid pathology and vascular risk are associated with distinct patterns of cerebral white matter hyperintensities: A multicenter study in 3132 memory clinic patients. Alzheimers Dement, 20(4), 2980-2989. https://doi.org/10.1002/alz.13765
Charidimou, A., Boulouis, G., Frosch, M. P., Baron, J. C., Pasi, M., Albucher, J. F., Banerjee, G., Barbato, C., Bonneville, F., Brandner, S., Calviere, L., Caparros, F., Casolla, B., Cordonnier, C., Delisle, M. B., Deramecourt, V., Dichgans, M., Gokcal, E., Herms, J.,…Greenberg, S. M. (2022). The Boston criteria version 2.0 for cerebral amyloid angiopathy: a multicentre, retrospective, MRI-neuropathology diagnostic accuracy study. Lancet Neurol, 21(8), 714-725. https://doi.org/10.1016/S1474-4422(22)00208-3
Ketter, N., Brashear, H. R., Bogert, J., Di, J., Miaux, Y., Gass, A., Purcell, D. D., Barkhof, F., & Arrighi, H. M. (2017). Central Review of Amyloid-Related Imaging Abnormalities in Two Phase III Clinical Trials of Bapineuzumab in Mild-To-Moderate Alzheimer’s Disease Patients. J Alzheimers Dis, 57(2), 557-573. https://doi.org/10.3233/JAD-160216
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