Effects of Intensive Lifestyle Changes on the Progression of Mild Cognitive Impairment or Early Dementia Due to Alzheimer's Disease: the Need for Rigor
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Abstract
We consider the recent publication by Ornish and colleagues and the rigor expected for interventional clinical trials. We contend that lifestyle intervention trials should strive for the same rigor as drug trials and highlight opportunities to improve rigor in this example, particularly in design, data analysis, and publication of results for this and other lifestyle intervention studies.
References
1.
Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R
. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015; 385(9984):2255-63.
DOI: 10.1016/S0140-6736(15)60461-5.
View
2.
Erickson K, Grove G, Burns J, Hillman C, Kramer A, McAuley E
. Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE): Protocol. Contemp Clin Trials. 2019; 85:105832.
PMC: 6815730.
DOI: 10.1016/j.cct.2019.105832.
View
3.
Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S
. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020; 396(10248):413-446.
PMC: 7392084.
DOI: 10.1016/S0140-6736(20)30367-6.
View
4.
Halpern S, Karlawish J, Berlin J
. The continuing unethical conduct of underpowered clinical trials. JAMA. 2002; 288(3):358-62.
DOI: 10.1001/jama.288.3.358.
View
5.
Gardener S, Fuller S, Naismith S, Baker L, Kivipelto M, Villemagne V
. The AUstralian multidomain Approach to Reduce dementia Risk by prOtecting brain health With lifestyle intervention study (AU-ARROW): A study protocol for a single-blind, multi-site, randomized controlled trial. Alzheimers Dement (N Y). 2024; 10(2):e12466.
PMC: 11002765.
DOI: 10.1002/trc2.12466.
View