ArticleAmerican journal of neurodegenerative disease2012
Advances in designs for Alzheimer's disease clinical trials.
Article in American journal of neurodegenerative disease, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed.
- Safety, Tolerability, and Pharmacokinetics of Crenezumab in Patients with Mild-to-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133 Weeks.Journal of Alzheimer's disease : JAD · 2020Trial
- Delayed-Start Analyses in the Phase 3 Solanezumab EXPEDITION3 Study in Mild Alzheimer's Disease.The journal of prevention of Alzheimer's disease · 2018Trial
- Research satisfaction among participants in a preclinical Alzheimer's disease trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Bridging Research, Policy, and Practice: Advancing Evidence-Informed Approaches for Dementia Care and Prevention: an expert review by the Health Policy Professional Interest Area from ISTAART.Alzheimer's & dementia. Behavior & socioeconomics of aging · 2026Article
- Integrating genetic and immune profiles for personalized immunotherapy in Alzheimer's disease.Frontiers in medicine · 2025Review
- A Review of the Recent Advances in Alzheimer's Disease Research and the Utilization of Network Biology Approaches for Prioritizing Diagnostics and Therapeutics.Diagnostics (Basel, Switzerland) · 2022Review
- Beneficial Effects of Fingolimod in Alzheimer's Disease: Molecular Mechanisms and Therapeutic Potential.Neuromolecular medicine · 2019Review
- Statistical advances in clinical trials and clinical research.Alzheimer's & dementia (New York, N. Y.) · 2018Article
- Detection of Rater Errors on Cognitive Instruments in a Clinical Trial Setting.The journal of prevention of Alzheimer's disease · 2018Article
- The futility study--Progress over the last decade.Contemporary clinical trials · 2015Article
- Effect of sample size re-estimation in adaptive clinical trials for Alzheimer's disease and mild cognitive impairment.Alzheimer's & dementia (New York, N. Y.) · 2015Article
- Fluid Biomarkers in Clinical Trials of Alzheimer's Disease Therapeutics.Frontiers in neurology · 2015Review
- For how long should we use symptomatic therapies to treat people with Alzheimer disease?Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2014Article
- A Novel Study Paradigm for Long-term Prevention Trials in Alzheimer Disease: The Placebo Group Simulation Approach (PGSA): Application to MCI data from the NACC database.The journal of prevention of Alzheimer's disease · 2014Article
- Toward the right treatment at the right time: Modeling the trajectory of cognitive decline to identify the earliest age of change in people with Alzheimer's disease.Alzheimer's & dementia (Amsterdam, Netherlands)Article
- Computerized Neurocognitive Test (CNT) in mild cognitive impairment and Alzheimer's disease.Dementia & neuropsychologiaReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
There is an urgent need to identify new treatments for the rapidly growing population of people with Alzheimer's disease (AD). Innovations in clinical trial designs many help to reduce development time, provide more definitive answers regarding drug efficacy, and facilitate prioritizing compounds to be advanced to Phase III clinical trials. Standard designs compare drug and placebo changes from baseline on a rating scale. Baysian adaptive clinical trials allow the use of data collected in the trial to modify doses, sample size, trial duration, and entry criteria in an ongoing way as the data are collected. Disease-modification is supported by findings on staggered start and delayed withdrawal designs. Futility designs can use historical controls and may shorten trial duration. Combination therapy designs may allow investigation of additive or synergistic treatment effects. Novel trial selection criteria allow investigation of treatment effects in asymptomatic or minimally symptomatic, prodromal AD populations. The Clinical Dementia Rating-Sum of Boxes (CDR-SOB) can be considered as a single trial outcome in early disease populations. Alternate forms of the Alzheimer's Disease Assessment Scale-Cognitive Portion (ADAS-cog), computerized measures, and pharmacoeconomic scales provide new and relevant information on drug effects. Comparative dose strategies are used in trials of symptomatic agents, and novel methods including withdrawal designs, symptom emergence analyses, and sequential designs are being utilized to assess the efficacy of putative psychotropic agents. The choice of trial design is driven by the question to be answered by the clinical trial; an increasing number of design approaches are available and may be useful in accelerating and refining AD drug development.
Indexed as
Identifiers
23383393PMC3560467What 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.