Trial reportAlzheimer's research & therapy2021
Research diagnostic criteria for Alzheimer's disease: findings from the LipiDiDiet randomized controlled trial.
Trial report in Alzheimer's research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Multimodal Deep Learning Approaches for Early Detection of Alzheimer's Disease: A Comprehensive Systematic Review of Image Processing Techniques.Current Alzheimer research · 2025Pooled it
- Predicting future dementia from routine clinical MRI and linked healthcare data.Alzheimer's research & therapy · 2026Article
- Neural biomarker diagnosis and prediction to mild cognitive impairment and Alzheimer's disease using EEG technology.Alzheimer's research & therapy · 2023Article
- Importance of high-quality evidence regarding the use of Bacopa monnieri in dementia.Frontiers in aging neuroscience · 2023Review
- Urinary Cytokines as Potential Biomarkers of Mild Cognitive Impairment and Alzheimer's Disease: A Pilot Study.Journal of Alzheimer's disease reports · 2023Article
- β-Amyloid, Tau, Neurodegeneration Classification and Eligibility for Anti-amyloid Treatment in a Memory Clinic Population.Neurology · 2022Article
- Use of Bacopa monnieri in the Treatment of Dementia Due to Alzheimer Disease: Systematic Review of Randomized Controlled Trials.Interactive journal of medical research · 2022Review
- Multimodal Preventive Trial for Alzheimer's Disease: MIND-ADmini Pilot Trial Study Design and Progress.The journal of prevention of Alzheimer's disease · 2022Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo explore the utility of the International Working Group (IWG)-1 criteria in recruitment for Alzheimer's disease (AD) clinical trials, we applied the more recently proposed research diagnostic criteria to individuals enrolled in a randomized controlled prevention trial (RCT) and assessed their disease progression.
methodsThe multinational LipiDiDiet RCT targeted 311 individuals with IWG-1 defined prodromal AD. Based on centrally analyzed baseline biomarkers, participants were classified according to the IWG-2 and National Institute on Aging-Alzheimer's Association (NIA-AA) 2011 and 2018 criteria. Linear mixed models were used to investigate the 2-year change in cognitive and functional performance (Neuropsychological Test Battery NTB Z scores, Clinical Dementia Rating-Sum of Boxes CDR-SB) (criteria × time interactions; baseline score, randomization group, sex, Mini-Mental State Examination (MMSE), and age also included in the models). Cox models adjusted for randomization group, MMSE, sex, age, and study site were used to investigate the risk of progression to dementia over 2 years.
resultsIn total, 88%, 86%, and 69% of participants had abnormal cerebrospinal fluid (CSF) β-amyloid, total tau, and phosphorylated tau, respectively; 64% had an A+T+N+ profile (CSF available for N = 107). Cognitive-functional decline appeared to be more pronounced in the IWG-2 prodromal AD, NIA-AA 2011 high and intermediate AD likelihood, and NIA-AA 2018 AD groups, but few significant differences were observed between the groups within each set of criteria. Hazard ratio (95% CI) for dementia was 4.6 (1.6-13.7) for IWG-2 prodromal AD (reference group no prodromal AD), 7.4 (1.0-54.7) for NIA-AA 2011 high AD likelihood (reference group suspected non-AD pathology SNAP), and 9.4 (1.2-72.7) for NIA-AA 2018 AD (reference group non-Alzheimer's pathologic change). Compared with the NIA-AA 2011 high AD likelihood group (abnormal β-amyloid and neuronal injury markers), disease progression was similar in the intermediate AD likelihood group (medial temporal lobe atrophy; no CSF available).
conclusionsDespite being less restrictive than the other criteria, the IWG-1 criteria reliably identified individuals with AD pathology. More pragmatic and easily applicable selection criteria might be preferred due to feasibility in certain situations, e.g., in multidomain prevention trials that do not specifically target β-amyloid/tau pathologies.
trial registrationNetherlands Trial Register, NL1620 . Registered on 9 March 2009.
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