NCT03528486

Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp

Completed NA Last updated 21 May 2024

What this trial tests

NA trial testing Music Training I in Mild Cognitive Impairment in 268 participants. Completed in 30 December 2021.

Timeline

29 January 2018

Primary endpoint
30 August 2021

30 December 2021

Quick facts

Lead sponsor	University of South Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	268
Start date	29 January 2018
Primary completion	30 August 2021
Estimated completion	30 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Music Training I

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Age-related Cognitive Decline — all drugs for Age-related Cognitive Decline →

Sponsor

University of South Florida

Who can join

60 and older, any sex, with Mild Cognitive Impairment or Age-related Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Different cognitive intervention approaches have been developed to attenuate decline (e.g., cognitive engagement, training, or stimulation), but it is not clear which approaches are efficacious. It is also not clear when, along the continuum of normal cognitive aging to mild cognitive impairment (MCI-a transitional stage before dementia onset), it is most efficacious to intervene. This randomized clinical trial will determine the efficacy of a novel cognitive engagement intervention approach (music training) as compared to cognitive stimulation (which will serve as a stringent, active control). Grounded in theory, the central hypothesis is that interventions enhancing central auditory processing (CAP), a strong, longitudinal predictor of MCI and dementia, will improve cognition. Music training is increasingly recognized as a feasible means to attenuate age-related cognitive decline. Prior research and preliminary data suggest that intense piano training enhances CAP and is likely more effective than cognitive stimulation. Correlational studies indicate superior CAP, executive function, and other cognitive abilities for adults with formal music training compared to non-musicians. The specific aims of the study are to examine the efficacy of music training relative to cognitive stimulation (active controls) to improve CAP, cognition, and everyday function among older adults with and without MCI. The efficacy of music training will be established and moderating effects of MCI status will be examined. The proposed study further aims to elucidate the underlying mechanisms of effective cognitive intervention approaches by exploring mediators of training gains. The proposed study is the first phase II randomized trial of music training to enhance older adults' cognition. Mediation analyses will elucidate the underlying mechanisms of intervention effects.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Keys to staying sharp: A randomized clinical trial of piano training among older adults with and without mild cognitive impairment.
   Hudak EM, Bugos J, Andel R, Lister JJ, et al · · 2019 · cited 5× · PMID 31226405 · DOI 10.1016/j.cct.2019.06.003
2. The Effects of Piano Training on Auditory Processing, Cognition, and Everyday Function.
   Lister JJ, Hudak EM, Andel R, Edwards JD. · · 2023 · cited 2× · PMID 41585426 · DOI 10.1007/s41465-023-00256-z
3. Auditory Processing but Not Peripheral Hearing Differs Between Older Adults With and Without Mild Cognitive Impairment.
   Lister JJ, Carmenate-Nichols R, Hudak EM, O'Brien JL, et al · · 2024 · cited 1× · PMID 38787303 · DOI 10.1044/2024_aja-23-00166
4. The influence of peer navigators on intervention adherence and retention among older adults: A study within a randomized trial - SWAT.
   Runge SK, Hudak EM, Sutfin JA, Dobrovolskiy VR, et al · · 2026 · PMID 41453521 · DOI 10.1016/j.cct.2025.108206