Outcome measures for Alzheimer's disease: A global inter‐societal Delphi consensus

Ellison, Tim; Cappa, Stefano F.; Garrett, Dawne; Georges, Jean; Iwatsubo, Takeshi; Kramer, Joel H.; Lehmann, Maryna; Maier, Andrea B.; Merrilees, Jennifer; Morris, John C.; Naismith, Sharon L.; Nobili, Flavio; Pahor, Marco; Pond, Dimity; Robinson, Louise; Soysal, Pınar; Vandenbulcke, Mathieu; Weber, Christopher J.; Visser, Pieter Jelle; Weiner, Michael W.; Frisoni, Giovanni B.

doi:10.1002/alz.12945

Cited by 7 publications

(3 citation statements)

References 118 publications

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“…Aligning with our experiences, a recently published global consensus did not list the DemQol as one of several ideal measures of QOL in dementia, including proxy and carer versions. 36 …”

Section: Discussionmentioning

confidence: 99%

Evaluating a model of best practice in primary care led post-diagnostic dementia care: feasibility and acceptability findings from the PriDem study

Griffiths,

Spencer,

Flanagan

et al. 2024

BMJ Open

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ObjectivesTo evaluate the feasibility and acceptability of a primary care-based intervention for improving post-diagnostic dementia care and support (PriDem), and implementation study procedures.DesignA non-randomised, mixed methods, feasibility study.SettingSeven general practices from four primary care networks (PCNs) in the Northeast and Southeast of England.ParticipantsWe aimed to recruit 80 people with dementia (PWD) and 66 carersInterventionClinical Dementia Leads delivered a 12-month intervention in participating PCNs, to develop care systems, build staff capacity and capability, and deliver tailored care and support to PWD and carers.OutcomesRecruitment and retention rates were measured. A mixed methods process evaluation evaluated feasibility and acceptability of the intervention and study procedures. Using electronic care records, researchers extracted service use data and undertook a dementia care plan audit, preintervention and postintervention, assessing feasibility of measuring the primary implementation outcome: adoption of personalised care planning by participating general practices. Participants completed quality of life, and service use measures at baseline, 4 and 9 months.Results60 PWD (75% of recruitment target) and 51 carers (77% of recruitment target) were recruited from seven general practices across four PCNs. Retention rate at 9 months was 70.0% of PWD and 76.5% of carers. The recruitment approach showed potential for including under-represented groups within dementia. Despite implementation challenges, the intervention was feasible and acceptable, and showed early signs of sustainability. Study procedures were feasible and accessible, although researcher capacity was crucial. Participants needed time and support to engage with the study. Care plan audit procedures were feasible and acceptable.ConclusionsThe PriDem model is an acceptable and feasible intervention. A definitive study is warranted to fully inform dementia care policy and personalised dementia care planning guidance. Successful strategies to support inclusion of PWD and their carers in future research were developed.Trial registration numberISRCTN11677384.

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“…Aligning with our experiences, a recently published global consensus did not list the DemQol as one of several ideal measures of QOL in dementia, including proxy and carer versions. 36 …”

Section: Discussionmentioning

confidence: 99%

Evaluating a model of best practice in primary care led post-diagnostic dementia care: feasibility and acceptability findings from the PriDem study

Griffiths,

Spencer,

Flanagan

et al. 2024

BMJ Open

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“…The Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) are the most popular cognitive assessment tools worldwide (12). Ellison et al (2022) in their global inter-societal Delphi consensus for outcomes measurements for Alzheimer's disease, through a strong consensus, recommended the MoCA and the MMSE for the assessment of memory and overall cognitive functioning in mild and moderate disease (13). Still, they have been shown to have a signi cant bias related to educational level (14,15).…”

Section: Introductionmentioning

confidence: 99%

The Montreal Cognitive Assessment in Spanish-speaking countries in Latin America and the Caribbean: A Systematic Review

Colina,

Paytan,

Mejía

et al. 2024

Preprint

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The worldwide prevalence of individuals living with dementia is on the rise and expected to reach 152.8 million people by 2050. This increase will affect disproportionately Low- and Middle Income Countries, which is already home to 60% of individuals living with dementia. Screening tools for early detection of mild cognitive impairment are crucial to provide patients with adequate diagnosis, timely interventions, and access to disease-modifying therapies. The Montreal Cognitive Assessment (MoCA) is one of the most widely used tests for cognitive assessment of first line, but its uniform application across Latin American and Caribbean (LAC) countries is questionable due to cultural and linguistic differences, a higher prevalence of low educational achievement and socioeconomical disparities. This systematic review for validation of the MoCA in Spanish-speaking LAC countries identified fourteen studies but only included twelve based on inclusion and exclusion criteria. We assessed the articles for cultural adaptation and translation reports using the Manchester Cultural Adaptation Questionnaire and the Manchester Translation Reporting Questionnaire. Only two studies reported significant adaptations to the original MoCA, with one study providing detailed cultural and lexical rationale. The adaptation process assessment revealed limited reporting on the translation steps involved, with few studies detailing the original author's involvement, professional translation, pilot testing, or healthcare professional input. This systematic review suggests the use of suitable cutoff scores, educational level-based scoring adjustments, and cultural awareness are key for adequate screening using the MoCA in LAC Spanish-speaking countries. PROSPERO Study registration number: CRD42023465794.

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“…Instead, cognitive and functional assessment batteries are used to elicit the severity of symptoms as proxies for the staging of disease, and also as clinical outcomes in clinical trials. However, these typical clinical trial outcome measures can be heterogeneous, lack adequate sensitivity to measure change in disease progression, and may not reflect what patients and other key stakeholders value the most [ 30 ], ultimately resulting in greater uncertainty regarding the value and meaningfulness of interventions. Assessments of QoL are often included as secondary endpoints in clinical trials [ 31 ].…”

Section: Introductionmentioning

confidence: 99%

Progression analysis versus traditional methods to quantify slowing of disease progression in Alzheimer’s disease

Jönsson,

Ivkovic,

Atri

et al. 2024

Alz Res Therapy

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Background The clinical meaningfulness of the effects of recently approved disease-modifying treatments (DMT) in Alzheimer’s disease is under debate. Available evidence is limited to short-term effects on clinical rating scales which may be difficult to interpret and have limited intrinsic meaning to patients. The main value of DMTs accrues over the long term as they are expected to cause a delay or slowing of disease progression. While awaiting such evidence, the translation of short-term effects to time delays or slowing of progression could offer a powerful and readily interpretable representation of clinical outcomes. Methods We simulated disease progression trajectories representing two arms, active and placebo, of a hypothetical clinical trial of a DMT. The placebo arm was simulated based on estimated mean trajectories of clinical dementia rating scale–sum of boxes (CDR-SB) recordings from amyloid-positive subjects with mild cognitive impairment (MCI) from Alzheimer’s Disease Neuroimaging Initiative (ADNI). The active arm was simulated to show an average slowing of disease progression versus placebo of 20% at each visit. The treatment effects in the simulated trials were estimated with a progression model for repeated measures (PMRM) and a mixed model for repeated measures (MMRM) for comparison. For PMRM, the treatment effect is expressed in units of time (e.g., days) and for MMRM in units of the outcome (e.g., CDR-SB points). PMRM results were implemented in a health economics Markov model extrapolating disease progression and death over 15 years. Results The PMRM model estimated a 19% delay in disease progression at 18 months and 20% (~ 7 months delay) at 36 months, while the MMRM model estimated a 25% reduction in CDR-SB (~ 0.5 points) at 36 months. The PMRM model had slightly greater power compared to MMRM. The health economic model based on the estimated time delay suggested an increase in life expectancy (10 months) without extending time in severe stages of disease. Conclusion PMRM methods can be used to estimate treatment effects in terms of slowing of progression which translates to time metrics that can be readily interpreted and appreciated as meaningful outcomes for patients, care partners, and health care practitioners.

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Outcome measures for Alzheimer's disease: A global inter‐societal Delphi consensus

Cited by 7 publications

References 118 publications

Evaluating a model of best practice in primary care led post-diagnostic dementia care: feasibility and acceptability findings from the PriDem study

Evaluating a model of best practice in primary care led post-diagnostic dementia care: feasibility and acceptability findings from the PriDem study

The Montreal Cognitive Assessment in Spanish-speaking countries in Latin America and the Caribbean: A Systematic Review

Progression analysis versus traditional methods to quantify slowing of disease progression in Alzheimer’s disease

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