Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp

Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp.

The primary objectives is to examine the efficacy of music training to improve central
auditory processing (CAP), cognition, and everyday function among older adults.

The secondary objectives are:

- To examine the moderating effects of mild cognitive impairment (MCI) on music training
efficacy.

- To explore mediators of intervention effects.

Design The design is a two arm randomized clinical trial examining the efficacy of music
training to improve CAP, cognition, and everyday function in older adults with and without
MCI across two time points (baseline and immediate post-test).

Outcomes The effects of of music training on CAP, cognition, and everyday functional
performance will be quantified.

CAP processing measures will include: Time Compressed Speech 65%, Words-in-Noise, Dichotic
Digits Test, Dichotic Sentence Identification, and Adaptive Tests of Temporal Resolution. A
composite will be derived from principal components analyses.

Cognition measures will include: Verbal Fluency Test (phonemic fluency, category fluency, and
category switching), Trail Making Test, and Digit Coding. A composite will be derived from
principal component analyses.

Everyday Function measures will include: Timed Instrumental Activities of Daily Living and
Test of Everyday Attention. A composite will be derived from principal component analyses.

Interventions and Duration Two types of music training will be investigated. The two training
conditions will be equivalent in terms of frequency and duration of each session (90 min/day,
two days/wk, 10 weeks) and social contact (led by trainer and conducted in groups of up to 10
persons).

Sample Size and Population In-person screening of a maximum of 500 potential study
participants are planned to enroll up to 400 participants. The goal is to have at least 200
participants complete the study. Individuals with normal cognition and those with a clinical
diagnosis of MCI will be included in the study.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

- Clinical diagnosis of dementia or other disorder that in the study physician's opinion
would limit the persons ability to participate in the study or benefit from the
interventions