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  ["project_title"]=>
  string(134) "Caregiver benefit from galantamine in Alzheimer's disease: mediation through patient cognitive, functional, and behavioral improvement"
  ["project_narrative_summary"]=>
  string(826) "Galantamine improves cognition, function, and behavior in Alzheimer's disease, and prior work has shown it also reduces caregiver time. However, whether these caregiver benefits require corresponding patient improvement — or can occur independently — is unknown. One trial found that donepezil improved cognition and function without reducing caregiver time; another showed lecanemab reduced caregiver burden before cognitive effects reached clinical significance. Using IPD from two randomized galantamine trials (GAL-INT-1, GAL-USA-1; N=1,289), this study will quantify the degree to which treatment effects on caregiver time and well-being are mediated by concurrent changes in patient cognition, function, and behavioral symptoms, identifying which clinical domains are most strongly associated with caregiver benefit."
  ["project_learn_source"]=>
  string(12) "scien_public"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(6) "Chenli"
    ["last_name"]=>
    string(3) "Zhu"
    ["degree"]=>
    string(11) "PhD Student"
    ["primary_affiliation"]=>
    string(26) "Capital Medical University"
    ["email"]=>
    string(26) "zhuchenli@mail.ccmu.edu.cn"
    ["state_or_province"]=>
    string(7) "Beijing"
    ["country"]=>
    string(5) "China"
  }
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      ["p_pers_f_name"]=>
      string(8) "Jingxuan"
      ["p_pers_l_name"]=>
      string(3) "Gao"
      ["p_pers_degree"]=>
      string(16) "Graduate Student"
      ["p_pers_pr_affil"]=>
      string(26) "Capital Medical University"
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      ["requires_data_access"]=>
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    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
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  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1467) "Background: Galantamine reduces caregiver time in Alzheimer's disease, but whether this requires corresponding patient improvement is unknown. Beyond one behavioral-domain mediation analysis (CATIE-AD, antipsychotics), no RCT study has tested how cognition and function mediate caregiver benefit for cholinesterase inhibitors.

Objective: To quantify the extent to which galantamine's effects on caregiver time (CARETIME) and well-being (PGWB) are mediated by changes in cognition (ADAS-cog), function (DAD), and behavioral symptoms (BEHAVE-AD).

Study Design: Planned secondary IPD analysis of GAL-INT-1 and GAL-USA-1 using multilevel longitudinal mediation models. Extension datasets and RIS-AUS-5 provide complementary descriptive and replication analyses.

Participants: 1,289 adults with mild-to-moderate Alzheimer's disease randomized to galantamine or placebo for 6 months.

Primary Outcome Measures: Change in CARETIME and PGWB during double-blind treatment.

Secondary Outcome Measures: Proportions mediated through each pathway; concordance between time and well-being changes; long-term trajectories; behavioral→burden mediation in RIS-AUS-5.

Statistical Analysis: Trial-stratified longitudinal mixed-effects models with ADAS-cog, DAD, and BEHAVE-AD as parallel mediators. Cross-lagged panel models when temporal ordering is uncertain; mediation demoted to association decomposition if timing assumptions are not met."
  ["project_brief_bg"]=>
  string(2883) "Sano and colleagues pooled GAL-INT-1 and GAL-USA-1 data and reported a net reduction of 32 minutes/day in caregiver time with galantamine.[1] Cummings and colleagues reported reduced NPI caregiver distress.[6] Donepezil and memantine trials have also shown improvements in caregiver time or burden.[9-11]

However, patient improvement and caregiver benefit are not linearly linked. The AD2000 trial showed that donepezil significantly improved MMSE (+0.8) and BADLS (+1.0) over two years, yet produced no effect on caregiver time, caregiver psychopathology, or institutionalization.[8] Conversely, lecanemab reduced caregiver burden in Clarity AD while mean cognitive effects remained below MCID thresholds.[14,15] A systematic review reported pooled effects of d=0.18 for caregiver burden and d=0.15 for caregiver time, noting that most antidementia trials do not report caregiver outcomes.[12] A review of 24 RCTs stated that the association between cognitive enhancers and caregiver burden "is unclear whether related to BPSD or cognitive/functional changes" — the mechanism has not been explicitly tested.[13]

Preliminary evidence points toward a three-domain transmission model. The CATIE-AD trial provides the only prior within-RCT formal mediation analysis: antipsychotic effects on caregiver burden were mediated by improvement in agitation and psychotic symptoms.[7] Handels and colleagues (9 cohorts, N=5,369) found that functional disability contributed approximately twice the care-time burden of cognitive impairment.[16] Kim and colleagues showed that BPSD fully mediated the effect of ADL/IADL decline on caregiver burden.[17]

Beyond CATIE-AD (behavioral domain, caregiver burden outcome), no within-RCT mediation analysis of the cognition→function→caregiver time pathway exists. Galantamine — with demonstrated cognitive, functional, and behavioral benefits — has not been examined for the degree to which its caregiver effects are transmitted through each domain. GAL-INT-1 and GAL-USA-1 concurrently collected patient three-domain data and caregiver CARETIME and PGWB data under the same randomization, enabling such a multi-domain longitudinal mediation analysis for the first time.

This study matters for three reasons. First, it tests whether the "caregiver benefit" reported in dementia trials is fully captured by standard patient endpoints — if a substantial portion is unexplained by measured patient change, current trial endpoints may be insufficient to account for how treatment affects caregivers. Second, it identifies which clinical domain is most strongly associated with caregiver outcomes, informing treatment targeting. Third, by comparing galantamine (cognitive/functional mechanism) with RIS-AUS-5 (behavioral mechanism, nursing staff caregivers), it provides evidence across drug classes and care settings."
  ["project_specific_aims"]=>
  string(1413) "1. Estimate treatment effects of galantamine on caregiver time (CARETIME) and caregiver psychological well-being (PGWB) during the double-blind phase.

2. Quantify the proportion of these effects mediated through cognitive (ADAS-cog), functional (DAD), and behavioral (BEHAVE-AD) pathways.

3. Examine whether residual caregiver benefit exists beyond measured patient change.

4. Compare the relative mediating strength of the three pathways.

5. Assess concordance between caregiver-time change and PGWB change.

6. Describe long-term caregiver-outcome trajectories in GAL-INT-3, GAL-USA-3, and GAL-INT-7.

7. Replicate the CATIE-AD behavioral→burden mediation in RIS-AUS-5, using NCAS.



Based on existing evidence, the following domain-differential hypotheses will be tested: (a) BEHAVE-AD change will mediate PGWB more strongly than CARETIME, as behavioral symptoms are the strongest predictor of caregiver distress (CATIE-AD mediation; Chen 2018); (b) DAD change will be the strongest mediator of CARETIME, as functional disability is the largest determinant of care time (Handels 2025: approximately twice the contribution of cognition); (c) ADAS-cog change will have weaker total indirect effects, operating mainly through DAD, consistent with evidence that cognition's independent effect on caregiver time attenuates after adjusting for function.

"
  ["project_study_design"]=>
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    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
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  ["project_research_methods"]=>
  string(1672) "Trials requested: GAL-INT-1 (NCT00253188, N=653), GAL-USA-1 (NCT00253201, N=636), GAL-INT-3 (N=469), GAL-USA-3 (NCT00304629, N=241), GAL-INT-7 (N=144), RIS-AUS-5 (NCT00249158, N=344). For each trial: anonymized IPD, CSR, Data Definition Specification, Annotated CRF, and SAP.

Inclusion (primary analysis): Adults enrolled in GAL-INT-1 or GAL-USA-1 who entered the double-blind phase with identifiable randomized treatment assignment (galantamine or placebo). CARETIME analysis: baseline and at least one post-baseline CARETIME record. PGWB analysis: baseline and at least one post-baseline PGWB record. Mediation analysis: corresponding visit records for treatment assignment, at least one mediator (ADAS-cog, DAD, BEHAVE-AD), and at least one outcome (CARETIME, PGWB).

Inclusion (extension): Participants in GAL-INT-3, GAL-USA-3, or GAL-INT-7 with at least two caregiver-outcome assessments. Analyses restricted to descriptive trajectories; causal comparisons only if CSR confirms an identifiable concurrent randomized comparator.

Inclusion (RIS-AUS-5): Participants with baseline and at least one post-baseline NCAS and CMAI assessment.

Exclusion: Participants will be excluded from a specific outcome analysis when the relevant domain was not collected at the required visits, treatment phase cannot be reliably identified, or the outcome variable cannot be mapped to the prespecified construct. Participants with partial follow-up are not excluded solely because of missingness if they contribute information to the longitudinal model. No additional exclusion criteria will be applied beyond those specified in the original trial protocols."
  ["project_main_outcome_measure"]=>
  string(1025) "Primary: (1) Change from baseline to end of double-blind treatment (6 months) in caregiver time, as recorded in the CARETIME domain. The exact variable (e.g., daily hours of active assistance by the unpaid caregiver) will be identified from the Data Definition Specification and Annotated CRF. Separate components (ADL assistance, supervision) will be analyzed individually where distinguishable. (2) Change from baseline to end of double-blind treatment in caregiver psychological well-being, as recorded in the PGWB domain.

Secondary: DEPENDS/DEPENDEN dependence scores; proportions of total treatment effects mediated through cognitive (ADAS-cog), functional (DAD), and behavioral (BEHAVE-AD) pathways; concordance of CARETIME and PGWB change; long-term caregiver-outcome trajectories in extension datasets (GAL-INT-3, GAL-USA-3, GAL-INT-7); change in NCAS during RIS-AUS-5 double-blind treatment. All variable definitions will be finalized from the data dictionary and documented before unblinded outcome analysis."
  ["project_main_predictor_indep"]=>
  string(475) "Randomized treatment assignment during the double-blind phase, categorized as placebo, galantamine 24 mg/day, or galantamine 32 mg/day. The primary analysis will compare pooled galantamine versus placebo. Dose-response analyses retaining the three-level categorization will be conducted as sensitivity analyses. All analyses preserve the randomized groups; participants will not be reclassified according to post-randomization adherence, treatment response, or observed dose."
  ["project_other_variables_interest"]=>
  string(804) "Mediators: ADAS-cog/11 (or /13), DAD, and BEHAVE-AD, operationalized as change scores from baseline to each follow-up visit. The exact scale version will be confirmed from the data dictionary; if trials used different behavioral instruments, the most comparable measure will be selected and any differences documented.

Covariates: Baseline disease severity (MMSE as continuous; ADAS-cog as continuous), dependence (DEPENDS/DEPENDEN, scoring to be confirmed), age (continuous), sex (binary), living setting (community vs residential care facility, where recorded), and caregiver relationship type (spouse vs adult child vs other, where available). Caregiver demographic variables are subject to anonymization restrictions; availability will be assessed after data access and reported transparently."
  ["project_stat_analysis_plan"]=>
  string(2548) "Data audit: Before unblinding, verify CARETIME and PGWB definitions and scoring, confirm temporal ordering of patient and caregiver outcome collection at each visit, construct cross-trial variable-mapping table.

Descriptive: Baseline characteristics, distributions and changes in each outcome, missingness by trial and treatment group.

Treatment effect estimation: Trial-stratified longitudinal mixed-effects models including treatment, visit time, treatment-by-time interaction, baseline values, and trial indicators. Between-group differences at the double-blind endpoint reported with 95% CIs. Right-skewed or zero-inflated outcomes supplemented with two-part or generalized linear mixed models.

Primary mediation analysis: Multilevel longitudinal mediation framework or multilevel SEM. Exposure: randomized treatment. Parallel mediators: longitudinal changes in ADAS-cog, DAD, BEHAVE-AD. Outcomes: CARETIME and PGWB. Estimands: total effect, indirect effects via each pathway, total indirect effect and proportion mediated, direct effect.

When mediators and outcomes share the same visit, cross-lagged panel models or difference-score path analysis will be used. Interpretation demoted to "longitudinal association decomposition" when temporal ordering is not established. Formal causal mediation claims require: no unmeasured exposure-mediator confounding (satisfied by randomization), no unmeasured mediator-outcome confounding (covariate adjustment + sensitivity analysis), correct temporal ordering (verified from visit structure).

Pathway comparison: Indirect effect magnitudes and confidence intervals compared across pathways.

Effect modification: Baseline severity, dependence, and living setting tested as modifiers of mediation effects. Exploratory.

Concordance: Residual correlations between CARETIME and PGWB in joint models.

Sensitivity: Baseline-to-endpoint simple mediation vs. full longitudinal mediation; behavioral subscale substitution; missing-data impact on mediation estimates.

Extension datasets: GAL-INT-3: compare "continuous galantamine" (INT-1 galantamine→INT-3) and "delayed galantamine" (INT-1 placebo→INT-3) PGWB/CARETIME trajectories. Grouping non-randomized. GAL-INT-7 and GAL-USA-3: descriptive trajectories.

RIS-AUS-5: Independent analysis; NCAS as outcome, CMAI as mediator, same framework.

Multiplicity: Two caregiver outcomes and three mediation pathways prespecified. Effect sizes, 95% CIs, and proportions mediated reported."
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      ["label"]=>
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  ["project_timeline"]=>
  string(611) "Anticipated project start: upon DUA execution and data access. Key milestones:

 - Months 1–4: Data receipt, CSR/dictionary review, variable audit, treatment-phase verification, cross-trial mapping, and protocol preregistration on OSF.

 - Months 4–8: Primary longitudinal treatment-effect and mediation analyses for GAL-INT-1 and GAL-USA-1.

 - Months 8–10: Sensitivity analyses, long-term dataset and RIS-AUS-5 supplementary analyses.

 - Months 10–12: Manuscript drafting, internal review, first submission to target journal, and results reported back to YODA Project.

"
  ["project_dissemination_plan"]=>
  string(895) "The primary manuscript will be submitted to a peer-reviewed journal (Neurology, Alzheimer's & Dementia, International Journal of Geriatric Psychiatry, or JAMDA). Target audiences include dementia researchers, geriatric psychiatrists, neurologists, health-services researchers, and clinical trial methodologists. The protocol will be preregistered on OSF after data access approval. All analysis code and derived variable definitions will be released under an open-source license upon publication. Findings will be presented at relevant scientific conferences (e.g., Alzheimer's Association International Conference, International Psychogeriatric Association congress). Supplementary manuscripts may address RIS-AUS-5 pathway validation and long-term caregiver-outcome trajectories. All publications will acknowledge the YODA Project and comply with its publication and data-use requirements."
  ["project_bibliography"]=>
  string(4130) "
1. Sano M, Wilcock GK, van Baelen B, et al. The effects of galantamine treatment on caregiver time in Alzheimer’s disease. Int J Geriatr Psychiatry. 2003;18(10):942-950. doi:10.1002/gps.1000.

2. ClinicalTrials.gov. GAL-INT-1. Identifier: NCT00253188.

3. ClinicalTrials.gov. GAL-USA-1. Identifier: NCT00253201.

4. Wilcock GK, Lilienfeld S, Gaens E. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer’s disease. BMJ. 2000;321(7274):1445-1449. doi:10.1136/bmj.321.7274.1445.

5. Raskind MA, Peskind ER, Wessel T, et al. Galantamine in AD: a 6-month randomized, placebo-controlled trial with a 6-month extension. Neurology. 2000;54(12):2261-2268. doi:10.1212/wnl.54.12.2261.

6. Cummings JL, Schneider L, Tariot PN, et al. Reduction of behavioral disturbances and caregiver distress by galantamine in patients with Alzheimer’s disease. Am J Psychiatry. 2004;161(3):532-538. doi:10.1176/appi.ajp.161.3.532.

7. Mohamed S, Rosenheck R, Lyketsos CG, et al. Effect of second-generation antipsychotics on caregiver burden in Alzheimer’s disease. J Clin Psychiatry. 2012;73(1):121-128. doi:10.4088/JCP.10m06574.

8. Courtney C, Farrell D, Gray R, et al. Long-term donepezil treatment in 565 patients with Alzheimer’s disease (AD2000). Lancet. 2004;363(9427):2105-2115. doi:10.1016/S0140-6736(04)16499-4.

9. Wimo A, Winblad B, Shah SN, et al. Impact of donepezil treatment for Alzheimer’s disease on caregiver time. Curr Med Res Opin. 2004;20(8):1221-1225. doi:10.1185/030079902125004349.

10. Wimo A, Winblad B, Stöffler A, et al. Resource utilisation and cost analysis of memantine in patients with moderate to severe Alzheimer’s disease. Pharmacoeconomics. 2003;21(5):327-340. doi:10.2165/00019053-200321050-00004.

11. Feldman H, Gauthier S, Hecker J, et al. Efficacy of donepezil on maintenance of activities of daily living in patients with moderate to severe Alzheimer’s disease and the effect on caregiver burden. J Am Geriatr Soc. 2003;51(6):737-744. doi:10.1046/j.1365-2389.2003.51260.x.

12. Lingler JH, Martire LM, Schulz R. Caregiver-specific outcomes in antidementia clinical drug trials: a systematic review and meta-analysis. J Am Geriatr Soc. 2005;53(6):983-990. doi:10.1111/j.1532-5415.2005.53313.x.

13. Levy K, Lanctôt KL, Farber SB, et al. Does pharmacological treatment of neuropsychiatric symptoms in Alzheimer’s disease relieve caregiver burden? Drugs Aging. 2012;29(3):167-179. doi:10.2165/11599140-000000000-00000.

14. Cohen S, van Dyck CH, Gee M, et al. Lecanemab Clarity AD: quality-of-life results. J Prev Alzheimers Dis. 2023;10(4):771-777. doi:10.14283/jpad.2023.123.

15. Muir RT, Hill MD, Black SE, et al. Minimal clinically important difference in Alzheimer’s disease: rapid review. Alzheimers Dement. 2024;20(5):3352-3363. doi:10.1002/alz.13770.

16. Handels R, Hataiyusuk S, Wimo A, et al. Informal care for people with dementia in Europe. J Prev Alzheimers Dis. 2025;12(1):100015. doi:10.1016/j.tjpad.2024.100015.

17. Kim B, Noh GO, Kim K. Behavioural and psychological symptoms of dementia in patients with Alzheimer’s disease and family caregiver burden: a path analysis. BMC Geriatr. 2021;21(1):160. doi:10.1186/s12877-021-02109-w.

18. Chen P, Guarino PD, Dysken MW, et al. Neuropsychiatric symptoms and caregiver burden in individuals with Alzheimer’s disease: TEAM-AD. J Geriatr Psychiatry Neurol. 2018;31(4):177-185. doi:10.1177/0891988718783897.

19. Frank L, Kleinman L, Ciesla G, et al. The effect of risperidone on nursing burden associated with caring for patients with dementia. J Am Geriatr Soc. 2004;52(9):1449-1455. doi:10.1111/j.1532-5415.2004.52406.x.

20. Wimo A, Nordberg G. Validity and reliability of assessments of time. Arch Gerontol Geriatr. 2007;44(1):71-81. doi:10.1016/j.archger.2006.03.001.

21. Debray TPA, Moons KGM, van Valkenhoef G, et al. Get real in individual participant data meta-analysis. Res Synth Methods. 2015;6(4):293-309. doi:10.1002/jrsm.1160.
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