Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp

NCT03528486 | Completed

• 1 other identifier: 32335
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Age-related Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Cognition

  A composite of performance on Verbal fluency words generated, Trail Making Test time, and Digit Symbol Coding number correct derived from principal components analyses

  change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months

Secondary Outcomes (2)

• Central Auditory Processing

  change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months

• Everyday Function

  change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months

Other Outcomes (2)

• General Self Efficacy

  Change from prior to training content exercises to immediately after training content exercises, at the end of intervention phase which is about three months

• Music Self Efficacy

  Change from prior to training content exercises to immediately after training content exercises, at the end of intervention phase which is about three months

Study Arms (2)

Music Training I

EXPERIMENTAL

Participants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument.

Behavioral: Music Training I

Music Training II

ACTIVE COMPARATOR

Participants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument

Behavioral: Music Training I

Interventions

Music Training I BEHAVIORAL

Participants will be attending group classes, guided by a trainer, with up to 10 other older adults.

Music Training I; Music Training II

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 60 years or older
• willingness to provide informed consent
• willingness to complete up to 23 study visits including attending in-lab intervention two times a week for a three-month period with the goal of completing 20 sessions.
• ability to speak and understand English
• Montreal Cognitive Assessment score of 20 or higher (score 20 to 30 inclusive)
• intact vision (binocular near visual acuity of 20/50 or better tested with a standard near visual acuity chart)
• adequate hearing acuity (no greater than a moderate hearing loss \[thresholds \<70 dB HL\] in the mid-frequency range \[1000, 2000 Hz\] in at least one ear as determined by a standard pure tone hearing evaluation)
• Music Reading Assessment score of 18 or lower (score 0-18 inclusive)
• ability to understand study procedures and comply with them for the length of the study in the tester's opinion (and other study personnel opinion who interact with participant, such as the study physician)

You may not qualify if:

• moderate or worse depressive symptoms (Geriatric Depression Scale short form score \>=5)
• previous participation in University of South Florida (USF) Cognitive Aging Lab intervention studies
• previous participation in 10 or more hours of a computerized cognitive intervention computer programs (e.g., Lumosity, Posit Science Brain Fitness, InSight, or BrainHQ; Lace, CogMed, CogniFit, Happy Neuron, Dakim, DriveSharp or Staying Sharp programs)
• currently enrolled in another research study
• planning on being away for two or more weeks during the next five months (recruit later)
• undergoing chemotherapy or radiation treatment or planning surgeries or other procedures requiring anesthesia within the next five months (recruit later)
• four or more years of formal music training such as private lessons or group lessons on a specific instrument
• ability to read music on two or more of the following clefs: Treble clef, Bass clef, Alto clef
• four or more years of playing any one musical instrument
• currently practicing or participating in any music activities- such as music performance or music reading or music lessons
• difficulty and pain in moving hands or fingers, or neuropathy affecting hands, or tremor in either hand
• self-reported diagnosis of dementia, stroke, serious brain injury or neurological disorder
• diagnosed by a physician or nurse with a TIA that occurred within the last 18 months
• inability or unwillingness to give written informed consent at baseline
• Clinical Dementia Rating Scale score of 1 or greater

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

Related Publications (2)

• Runge SK, Hudak EM, Sutfin JA, Dobrovolskiy VR, Edwards JD. The influence of peer navigators on intervention adherence and retention among older adults: A study within a randomized trial - SWAT. Contemp Clin Trials. 2025 Dec 24;161:108206. doi: 10.1016/j.cct.2025.108206. Online ahead of print.

  PMID: 41453521 DERIVED

• Hudak EM, Bugos J, Andel R, Lister JJ, Ji M, Edwards JD. Keys to staying sharp: A randomized clinical trial of piano training among older adults with and without mild cognitive impairment. Contemp Clin Trials. 2019 Sep;84:105789. doi: 10.1016/j.cct.2019.06.003. Epub 2019 Jun 18.

  PMID: 31226405 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: May 17, 2018
• Study Start: January 29, 2018
• Primary Completion: August 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)