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Randomized Controlled Trial
. 2023 Nov;19(11):4863-4871.
doi: 10.1002/alz.13078. Epub 2023 Apr 10.

Impact of multivitamin-mineral and cocoa extract on incidence of mild cognitive impairment and dementia: Results from the COcoa Supplement and Multivitamin Outcomes Study for the Mind (COSMOS-Mind)

Affiliations
Randomized Controlled Trial

Impact of multivitamin-mineral and cocoa extract on incidence of mild cognitive impairment and dementia: Results from the COcoa Supplement and Multivitamin Outcomes Study for the Mind (COSMOS-Mind)

Bonnie C Sachs et al. Alzheimers Dement. 2023 Nov.

Abstract

Introduction: We assessed the effects of multivitamin-mineral and cocoa extract supplementation on incident mild cognitive impairment (MCI) and all-cause probable dementia.

Methods: COSMOS-Mind (N = 2262), a 2 × 2 factorial, randomized-controlled clinical trial administered a telephone-based cognitive battery at baseline and annually for 3 years. Incidence rates of MCI, and separately dementia, were compared among treatment arms with proportional hazards regression.

Results: Over 3 years, 110 incident MCI and 14 incident dementia cases were adjudicated. Incidence rates did not vary by assignment to multivitamin-mineral or cocoa extract (all p's ≥ 0.05); however, statistical power was low. When participants assigned to multivitamin-mineral versus placebo converted to MCI, their scores for global cognition (p = 0.03) and executive function (p < 0.001) were higher and had declined less relative to the previous year (p = 0.03 for global cognition; p = 0.004 for executive function).

Discussion: Multivitamin-mineral therapy may provide cognitive resilience, countering conversion to MCI, but not significantly reduce its incidence over 3 years.

Highlights: Multivitamin-mineral supplementation did not reduce risks for cognitive impairment. Cocoa extract supplementation did not reduce risks for cognitive impairment. Multivitamin-mineral supplementation slowed cognitive declines for incident mild cognitive impairment.

Keywords: cognitive impairment; dietary supplements; pragmatic clinical trial.

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Conflict of interest statement

BCS has received research support from the NIH and Alzheimer’s Association and honorarium for consulting with the Alzheimer’s Association. BJW has received research support from the NIH. SAG has received research support from the NIH. LDB has received research support from the NIH and Alzheimer’s Association and honoraria from speakerships and advisory boards from Massachusetts General Hospital, the Johns Hopkins University, Washington State University, and the University of California at San Diego. JEM has received research support from the NIH, Mars Edge, and Pfizer. MAE has received research support from the NIH and Alzheimer’s Association, travel support from the Alzheimer’s Association, and compensation for service on Data and Safety Monitoring Boards and a Steering Committee for a study organized by Nestle. HDS has received research support from the NIH, Mars Edge, Pfizer, and Pure Encapsulations Inc.; has received honorarium from the Council for Responsible Nutrition, the BASF, and the NIH; and has received support for travel from the Council for Responsible Nutrition. SRR and SAS have received research support from the NIH.

Figures

Figure 1:
Figure 1:
Cumulative distribution of times until the first incidence of a trigger of cognitive adjudication based on TICSm scores with cumulative numbers of cases and results (hazard ratio) from proportional hazards regression: hazard ratio [95% confidence interval] HR=0.73 [0.54,0.98].

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References

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