ArticleAlzheimer's research & therapy2018
Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program.
Article in Alzheimer's research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Who cites it
15 citing papers in PubMed.
- Charting neuroethics discourse in Africa: A scoping review of ethical issues of neuroscience research in Africa.IBRO neuroscience reports · 2025Article
- Globalization of Alzheimer's disease clinical trials: Current characteristics and future goals.International psychogeriatrics · 2025Review
- Immediate Reactions to Alzheimer Biomarker Disclosure in Cognitively Unimpaired Individuals in a Global Truncated Randomized Trial.Neurology. Clinical practice · 2024Article
- Progression analysis versus traditional methods to quantify slowing of disease progression in Alzheimer's disease.Alzheimer's research & therapy · 2024Article
- A call for clinical trial globalization in Alzheimer's disease and related dementia.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2023Article
- Perspectives and challenges in patient stratification in Alzheimer's disease.Alzheimer's research & therapy · 2022Review
- How understudied populations have contributed to our understanding of Alzheimer's disease genetics.Brain : a journal of neurology · 2021Review
- Diagnosis of Alzheimer's Disease in Developed and Developing Countries: Systematic Review and Meta-Analysis of Diagnostic Test Accuracy.Journal of Alzheimer's disease reports · 2021Article
- Recruitment and retention of participant and study partner dyads in two multinational Alzheimer's disease registration trials.Alzheimer's research & therapy · 2021Article
- An international, randomized, placebo-controlled, phase 2b clinical trial of intepirdine for dementia with Lewy bodies (HEADWAY-DLB).Alzheimer's & dementia (New York, N. Y.) · 2021Article
- Intepirdine as adjunctive therapy to donepezil for mild-to-moderate Alzheimer's disease: A randomized, placebo-controlled, phase 3 clinical trial (MINDSET).Alzheimer's & dementia (New York, N. Y.) · 2021Article
- Baseline demographic, clinical, and cognitive characteristics of the Alzheimer's Prevention Initiative (API) Autosomal-Dominant Alzheimer's Disease Colombia Trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2020Article
- Statistical Disease Progression Modeling in Alzheimer Disease.Frontiers in big data · 2020Article
- The "rights" of precision drug development for Alzheimer's disease.Alzheimer's research & therapy · 2019Review
- Decision making in clinical trials: Interim analyses, innovative design, and biomarkers.Alzheimer's & dementia (New York, N. Y.)Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
backgroundGlobalization of clinical trials has important consequences for trial planning and interpretation. This study investigated heterogeneity in patient characteristics and outcomes among world regions in the global idalopirdine Phase 3 clinical program.
methodsData were pooled from three 24-week randomized controlled trials in patients aged ≥ 50 years with mild-to-moderate Alzheimer's disease (AD) (n = 2506). Patients received idalopirdine (10, 30, or 60 mg/day) or placebo, added to cholinesterase inhibitor treatment. Patients were categorized into the following regions: Eastern Europe/Turkey (n = 759), Western Europe/Israel (n = 709), USA/Canada (n = 444), South America/Mexico (n = 361), Asia (n = 134), and Australia/South Africa (n = 99). For each region, operational characteristics, baseline demographic and clinical characteristics, adverse events, and mean change from baseline to week 24 in clinical rating scale scores (placebo group only) were summarized using descriptive statistics.
resultsCompletion rates were 0.86-0.90 in all regions. Heterogeneity among global regions was evident. Protocol deviations were twice as common in South America/Mexico as in USA/Canada (2.64 vs 1.35 per patient screened). Educational level ranged from 9.2 years in South America/Mexico to 13.4 years in USA/Canada. APOE ε4 carriage was 80.6% in Australia/South Africa, 63.1% in Western Europe/Israel, and < 60% in other regions. Screening Mini-Mental State Examination scores were higher in Eastern Europe/Turkey (18.0) and USA/Canada (17.5) than in other regions (16.9-17.1). Baseline AD Assessment Scale-Cognitive subscale (ADAS-Cog) scores ranged from 24.3 in USA/Canada to 27.2 in South America/Mexico. Baseline AD Cooperative Study-Activities of Daily Living, 23-item version (ADCS-ADL
conclusionsRegional heterogeneity-in terms of study conduct, patient characteristics, and outcomes-exists, and should be accounted for, when planning and conducting multinational AD clinical trials.
trial registrationClinicalTrials.gov, NCT01955161 . Registered on 27 September 2013. ClinicalTrials.gov, NCT02006641 . Registered on 5 December 2013. ClinicalTrials.gov, NCT02006654 . Registered on 5 December 2013.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.