Trial reportJournal of neurology, neurosurgery, and psychiatry2016
ADCOMS: a composite clinical outcome for prodromal Alzheimer's disease trials.
Trial report in Journal of neurology, neurosurgery, and psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06639282 (SIPO1-AD), which is not on this map. Cited by 102 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
SIPO1-AD: A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Siponimod in Patients With Mild Alzheimer's Disease
Who cites it
102 citing papers in PubMed, 1 synthesis or guideline pooled it, 156 citations in OpenAlex.
- Clinically Important Benefits and Harms of Monoclonal Antibodies Targeting Amyloid for the Treatment of Alzheimer Disease: A Systematic Review and Meta-Analysis.Annals of family medicinePooled it
- Safety, tolerability and immunogenicity of vaccine ALZ-101 in patients with early Alzheimer's disease: randomised, controlled trial.Alzheimer's research & therapy · 2026Trial
- Validation of a novel cognitive-functional outcome measure optimized for early Alzheimer's Disease: Evidence from the VIVA-MIND trial.The journal of prevention of Alzheimer's disease · 2026Trial
- Long-term safety and efficacy of lecanemab in early Alzheimer's disease: Results from the clarity AD open-label extension study.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Trial
- Clarity AD: Asian regional analysis of a phase III trial of lecanemab in early Alzheimer's disease.The journal of prevention of Alzheimer's disease · 2025Trial
- Allogeneic mesenchymal stem cell therapy with laromestrocel in mild Alzheimer's disease: a randomized controlled phase 2a trial.Nature medicine · 2025Trial
- Trial
- "Time Saved" Calculations to Improve Decision-Making in Progressive Disease Studies.The journal of prevention of Alzheimer's disease · 2024Trial
- Plasma pTau181 Predicts Clinical Progression in a Phase 2 Randomized Controlled Trial of the 11β-HSD1 Inhibitor Xanamem® for Mild Alzheimer's Disease.Journal of Alzheimer's disease : JAD · 2024Trial
- Lecanemab for Patients With Early Alzheimer Disease: Bayesian Analysis of a Phase 2b Dose-Finding Randomized Clinical Trial.JAMA network open · 2023Trial
- A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody.Alzheimer's research & therapy · 2021Trial
- Joint impact of pathological burden and cognitive resilience on Alzheimer's disease risk.Nature medicine · 2026Article
- Anti-Amyloid Antibodies in the Treatment of Alzheimer's Disease: An Umbrella Review.Journal of clinical medicine · 2026Review
- Statistical inference for saved time based on disease progression curves in Alzheimer's disease research.Contemporary clinical trials communications · 2026Article
- The Prodromal Synucleinopathy Rating Scale: An Assessment in Patients With REM Sleep Behavior Disorder.Neurology · 2026Observational
- Optimizing Parkinson's disease progression scales using computational methods.NPJ Parkinson's disease · 2026Article
- Efficacy assessment in trials of complex and rare diseases: a comparison between the meta-analytic global statistical test and co-primary analysis.Frontiers in medical technology · 2026Article
- Speech and language outcome measures in clinical trials of Alzheimer's and Parkinson's diseases.Expert review of neurotherapeutics · 2026Review
- The impact of recent approvals on future alzheimer's disease clinical development: Statistical considerations for combination trials.The journal of prevention of Alzheimer's disease · 2025Article
- Reinventing "N" in the A/T/N framework: The case for digital.The journal of prevention of Alzheimer's disease · 2025Article
42 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundDevelopment of new therapies for Alzheimer's disease (AD) is increasingly focused on more mildly affected populations, and requires new assessment and outcome strategies. Patients in early stages of AD have mild cognitive decline and no, or limited, functional impairment. To respond to these assessment challenges, we developed a measurement approach based on established scale items that exhibited change in previous amnestic Mild Cognitive Impairment (aMCI) trials.
methodsPartial least squares regression with a longitudinal clinical decline model identified items from commonly used clinical scales with the highest combined sensitivity to change over time in aMCI and weighted these items according to their relative contribution to detecting clinical progression in patients' early stages of AD. The resultant AD Composite Score (ADCOMS) was assessed for its ability to detect treatment effect in aMCI/prodromal AD (pAD) clinical trial populations.
resultsADCOMS consists of 4 Alzheimer's Disease Assessment Scale-cognitive subscale items, 2 Mini-Mental State Examination items, and all 6 Clinical Dementia Rating-Sum of Boxes items. ADCOMS demonstrated improved sensitivity to clinical decline over individual scales in pAD, aMCI and in mild AD dementia. ADCOMS also detected treatment effects associated with the use of cholinesterase inhibitors in these populations. Improved sensitivity predicts smaller sample size requirements when ADCOMS is used in early AD trials.
conclusionsADCOMS is proposed as new standard outcome for pAD and mild AD dementia trials, and is progressing in a CAMD-sponsored qualification process for use in registration trials of pAD.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.