Design and baseline characteristics of the cocoa supplement and multivitamin outcomes study for the Mind: COSMOS-Mind

Baker, Laura D.; Rapp, Stéphen R.; Shumaker, Sally A.; Manson, JoAnn E.; Sesso, Howard D.; Gaussoin, Sarah A.; Harris, Darrin; Caudle, Brad; Pleasants, Debbie; Espeland, Mark A.

doi:10.1016/j.cct.2019.06.019

Cited by 8 publications

(13 citation statements)

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“…48 Details about testing procedures, including hearing acuity screening, and administration and scoring are published. 42 The primary outcome was a global cognition composite (reported as a z-score based on baseline data from the study cohort) formed from mean standardized (z) scores of pre-specified individual test metrics, with higher scores reflecting better performance. Key secondary outcomes included an episodic memory composite (Long Delay Word List Recall, SRI, SRII) and an executive function composite (OTMT-B, VF-C, VF-L, NST, DOT) that were also formed using mean standardized (z) scores.…”

Section: Discussionmentioning

confidence: 99%

“…The essential nutrients contained in the MVM (Centrum Silver; Pfizer Consumer Healthcare, now Haleon) are listed in Table S6. COSMOS‐Mind examined the effects of these supplements on cognitive function, and the details of study design, participant demographics, and baseline characteristics are published 42 . The study was conducted in accordance with The Code of Ethics of the World Medical Association, and was approved by the Institutional Review Board of Wake Forest University School of Medicine.…”

Section: Methodsmentioning

confidence: 99%

“…As previously described, 42 parent trial participants were recruited through mailings to Women's Health Initiative Extension Study participants and by Brigham and Women's Hospital to participants contacted for, but not randomized into, the vitamin D and OmegA‐3 TriaL, and through commercial mailing lists and media campaigns. As a result, 35,669 adults began a placebo run‐in, of which 21,442 (60%) were ultimately randomized into COSMOS.…”

Section: Methodsmentioning

confidence: 99%

“…Tests included the 50‐point modified Telephone Interview for Cognitive Status (TICSm with 10‐minute short delay word list recall), an additional 40‐minute Long Delay Word List Recall, 43 immediate and delayed Story Recall (SRI & II), 44 Oral Trail‐Making Test Part B (OTMT‐B, log transformed; Part A was administered for practice only), 45 Verbal Fluency by category (VF‐C) and letter (VF‐L), 46 Number Span (NS), 47 and Digit Ordering Test (DOT) 48 . Details about testing procedures, including hearing acuity screening, and administration and scoring are published 42 …”

Section: Methodsmentioning

confidence: 99%

“…The primary and secondary endpoints have been previously described 42 and were pre‐specified in the protocol (provided as a supplement). We followed the intention‐to‐treat approach: all participants were grouped as originally randomly assigned and scores from all cognitive assessments (baseline and Years 1, 2 and 3) for all participants were included in analyses.…”

Section: Methodsmentioning

confidence: 99%

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Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial

Baker

Manson

Rapp

et al. 2022

Alzheimer's & Dementia

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Introduction: Dietary supplements are touted for cognitive protection, but supporting evidence is mixed. COSMOS-Mind tested whether daily administration of cocoa extract (containing 500 mg/day flavanols) versus placebo and a commercial multivitamin-mineral (MVM) versus placebo improved cognition in older women and men. Methods: COSMOS-Mind, a large randomized two-by-two factorial 3-year trial, assessed cognition by telephone at baseline and annually. The primary outcome was a global cognition composite formed from mean standardized (z) scores (relative to baseline) from individual tests, including the Telephone Interview of Cognitive Status, Word List and Story Recall, Oral Trail-Making, Verbal Fluency, Number Span, and DigitOrdering. Using intention-to-treat, the primary endpoint was change in this composite with 3 years of cocoa extract use. The pre-specified secondary endpoint was change in the composite with 3 years of MVM supplementation. Treatment effects were also examined for executive function and memory composite scores, and in pre-specified subgroups at higher risk for cognitive decline.Results: A total of 2262 participants were enrolled (mean age = 73y; 60% women; 89% non-Hispanic White), and 92% completed the baseline and at least one annual assessment. Cocoa extract had no effect on global cognition (mean z-score = 0.03, 95% CI: -0.02 to 0.08; P = .28). Daily MVM supplementation, relative to placebo, resulted in a statistically significant benefit on global cognition (mean z = 0.07, 95% CI 0.02 to 0.12; P = .007), and this effect was most pronounced in participants with a history of cardiovascular disease (no history: 0.06, 95% CI 0.01 to 0.11; history: 0.14, 95% CI -0.02 to 0.31; interaction, nominal P = .01). Multivitamin-mineral benefits were also observed for memory and executive function. The cocoa extract by MVM group interaction was not significant for any of the cognitive composites.Discussion: Cocoa extract did not benefit cognition. However, COSMOS-Mind provides the first evidence from a large, long-term, pragmatic trial to support the potential efficacy of a MVM to improve cognition in older adults. Additional work is needed toThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial

Baker

Manson

Rapp

et al. 2022

Alzheimer's & Dementia

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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)

Sachs

Williams

Gaussoin

et al. 2023

Alzheimer's & Dementia

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INTRODUCTIONWe assessed the effects of multivitamin‐mineral and cocoa extract supplementation on incident mild cognitive impairment (MCI) and all‐cause probable dementia.METHODSCOSMOS‐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.RESULTSOver 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).DISCUSSIONMultivitamin‐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.

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Therapeutic Potential of Polyphenols in Cellular Reversal of Patho‐Mechanisms of Alzheimer's Disease Using In Vitro and In Vivo Models: A Comprehensive Review

Samal,

Srivastava,

Khan

et al. 2024

Phytotherapy Research

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Alzheimer's disease (AD) is considered one of the most common neurological conditions associated with memory and cognitive impairment and mainly affects people aged 65 or above. Even with tremendous progress in modern neuroscience, a permanent remedy or cure for this crippling disease is still unattainable. Polyphenols are a group of naturally occurring potent compounds that can modulate the neurodegenerative processes typical of AD. The present comprehensive study has been conducted to find out the preclinical and clinical potential of polyphenols and elucidate their possible mechanisms in managing AD. Additionally, we have reviewed different clinical studies investigating polyphenols as single compounds or cotherapies, including those currently recruiting, completed, terminated, withdrawn, or suspended in AD treatment. Natural polyphenols were systematically screened and identified through electronic databases including Google Scholar, PubMed, and Scopus based on in vitro cell line studies and preclinical data demonstrating their potential for neuroprotection. A total of 63 significant polyphenols were identified. A multimechanistic pathway for polyphenol's mode of action has been proposed in the study. Out of 63, four potent polyphenols have been identified as promising potential candidates, based on their reported clinical efficacy. Polyphenols hold tremendous scope for the development of a future drug molecule as a phytopharmaceutical that may be incorporated as an adjuvant to the therapeutic regime. However, more high‐quality studies with novel delivery methods and combinatorial approaches are required to overcome obstacles such as bioavailability and blood–brain barrier crossing to underscore the therapeutic potential of these compounds in AD management.

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Design and baseline characteristics of the cocoa supplement and multivitamin outcomes study for the Mind: COSMOS-Mind

Cited by 8 publications

References 33 publications

Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial

Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical 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)

Therapeutic Potential of Polyphenols in Cellular Reversal of Patho‐Mechanisms of Alzheimer's Disease Using In Vitro and In Vivo Models: A Comprehensive Review

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