Trial reportAmerican journal of medical genetics. Part A2011
Down syndrome and dementia: a randomized, controlled trial of antioxidant supplementation.
Trial report in American journal of medical genetics. Part A, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05023863 (The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients), which is not on this map. Cited by 60 papers, 10 of them syntheses 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.
The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients
Who cites it
60 citing papers in PubMed, 10 syntheses or guidelines pooled it, 137 citations in OpenAlex.
- Pharmacological Approaches to the Treatment of Dementia in Down Syndrome: A Systematic Review of Randomized Clinical Studies.Molecules (Basel, Switzerland) · 2022Pooled it
- Prenatal and Postnatal Therapies for Down's Syndrome and Associated Developmental Anomalies and Degenerative Deficits: A Systematic Review of Guidelines and Trials.Frontiers in medicine · 2022Pooled it
- Neurologic complications of Down syndrome: a systematic review.Journal of neurology · 2021Pooled it
- Meta-analysis of metabolites involved in bioenergetic pathways reveals a pseudohypoxic state in Down syndrome.Molecular medicine (Cambridge, Mass.) · 2020Pooled it
- Alpha-lipoic acid in the treatment of psychiatric and neurological disorders: a systematic review.Metabolic brain disease · 2019Pooled it
- Markers of oxidative damage to lipids, nucleic acids and proteins and antioxidant enzymes activities in Alzheimer's disease brain: A meta-analysis in human pathological specimens.Free radical biology & medicine · 2018Pooled it
- Vitamin E for Alzheimer's dementia and mild cognitive impairment.The Cochrane database of systematic reviews · 2017Pooled it
- Vitamin E for Alzheimer's dementia and mild cognitive impairment.The Cochrane database of systematic reviews · 2017Pooled it
- Pharmacological interventions for cognitive decline in people with Down syndrome.The Cochrane database of systematic reviews · 2015Pooled it
- Vitamin E for Alzheimer's dementia and mild cognitive impairment.The Cochrane database of systematic reviews · 2012Pooled it
- Vitamin E in aging persons with Down syndrome: A randomized, placebo-controlled clinical trial.Neurology · 2016Trial
- α-Tocopherol supplementation reduces biomarkers of oxidative stress in children with Down syndrome: a randomized controlled trial.European journal of clinical nutrition · 2014Trial
- Loss of Proteostasis and Early-Onset Neurodegeneration in Down Syndrome: From Mechanisms to Interventions.Antioxidants (Basel, Switzerland) · 2026Review
- Alpha-Lipoic Acid in Early-Stage Alcohol-Related Brain Damage in Rats: A Comparative Pilot Study.Molecules (Basel, Switzerland) · 2025Article
- Validation of the CAMCOG-DS-II, a neuropsychological test battery for Alzheimer's disease in people with Down syndrome: A Horizon 21 European Down syndrome Consortium study.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Article
- The Role of Oxidative Stress in Trisomy 21 Phenotype.Cellular and molecular neurobiology · 2023Review
- Reactive oxygen species, toxicity, oxidative stress, and antioxidants: chronic diseases and aging.Archives of toxicology · 2023Review
- Antioxidant and Anti-Inflammatory Compounds from Edible Plants with Anti-Cancer Activity and Their Potential Use as Drugs.Molecules (Basel, Switzerland) · 2023Review
- The Impact of Oxidative Stress on Pediatrics Syndromes.Antioxidants (Basel, Switzerland) · 2022Review
- The accumulation of copper in the brain of Down syndrome promotes oxidative stress: possible mechanism underlying cognitive impairment.Journal of clinical biochemistry and nutrition · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
Individuals with Down syndrome over age 40 years are at risk for developing dementia of the Alzheimer type and have evidence for chronic oxidative stress. There is a paucity of treatment trials for dementia in Down syndrome in comparison to Alzheimer disease in the general (non-Down syndrome) population. This 2-year randomized, double-blind, placebo-controlled trial assessed whether daily oral antioxidant supplementation (900 IU of alpha-tocopherol, 200 mg of ascorbic acid and 600 mg of alpha-lipoic acid) was effective, safe and tolerable for 53 individuals with Down syndrome and dementia. The outcome measures comprised a battery of neuropsychological assessments administered at baseline and every 6 months. Compared to the placebo group, those individuals receiving the antioxidant supplement showed neither an improvement in cognitive functioning nor a stabilization of cognitive decline. Mean plasma levels of alpha-tocopherol increased ~2-fold in the treatment group and were consistently higher than the placebo group over the treatment period. Pill counts indicated good compliance with the regimen. No serious adverse events attributed to the treatment were noted. We conclude that antioxidant supplementation is safe, though ineffective as a treatment for dementia in individuals with Down syndrome and Alzheimer type dementia. Our findings are similar to studies of antioxidant supplementation in Alzheimer disease in the general population. The feasibility of carrying out a clinical trial for dementia in Down syndrome is demonstrated.
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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.