Mild Cognitive ImpairmentNCT03528486
Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp
A study testing Music Training I in people with Mild Cognitive Impairment and Age-related Cognitive Decline, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Age-related Cognitive Decline
- What is being tested?
- Music Training I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions to Attenuate Cognitive Decline
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.
Read the detailed description
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.
- Being tested
- Music Training I
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Training IBehavioural
Participants will be attending group classes, guided by a trainer, with up to 10 other older adults.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Music Training I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
A composite will be formed from principal components analyses of number correct for performance on Time Compressed Speech Test (TCS), Words-in-Noise Test (WIN), Dichotic Digits Test (DDT), Dichotic Sentence Identification (DSI) and the threshold in ms of performance on the Adaptive Tests of Temporal Resolution (ATTR).
Measured: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Everyday Function
A composite will be formed from the time and accuracy of performance on the Timed IADL Test and The Test of Everyday Attention (TEA)
Measured: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start29 Jan 2018
- Primary completion30 Aug 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerri D. Edwards, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528486
- Sponsor's protocol ID
- 32335
- Status last verified
- May 2024
- First submitted
- 13 Mar 2018
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Feb;161:108206. doi: 10.1016/j.cct.2025.108206. Epub 2025 Dec 24.
PubMed 41453521Hudak 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.
PubMed 31226405
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Attenuate Cognitive Decline
- ClinicalTrials.gov ID
- NCT03528486
- Acronym / sponsor ID
- 32335
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Training I | Experimental | Behavioral: Music Training IParticipants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument. |
| Music Training II | Active comparator | Behavioral: Music Training IParticipants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Training IParticipants will be attending group classes, guided by a trainer, with up to 10 other older adults. | Behavioural | Music Training I, Music Training II |
Primary outcome
Cognition
Time frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
A composite of performance on Verbal fluency words generated, Trail Making Test time, and Digit Symbol Coding number correct derived from principal components analyses
2 secondary outcomes
Central Auditory Processing
Time frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Everyday Function
Time frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 41453521Runge 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. 2026 Feb;161:108206. doi: 10.1016/j.cct.2025.108206. Epub 2025 Dec 24.
- Derived from this study: PubMed 31226405Hudak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Training I in people with Mild Cognitive Impairment and Age-related Cognitive Decline, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528486, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.