Healthy Volunteer StudyMultiMusicNCT06767410

A Multi-domain Intervention for Healthy Aging

A study testing Multidomain Intervention and General activities in people with Healthy Volunteer Study, run by University of Bari at 4 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study aims to investigate the long-term impact of a non-pharmacological intervention including several activities (e.g., physical activity, choir, learning programs, horticulture, etc.) to prevent cognitive impairment in community-dwelling elderly individuals with aspects of frailty. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer Study
What is being tested?: Multidomain Intervention and General activities
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 4 sitesItaly
Study dates: 1 Oct 2025to Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Age ≥ 65
Living independently

Who cannot join

Musical expertise
Severe cognitive or functional impairment

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elvira Brattico, Professor contact

+390805714702

elvira.brattico@uniba.it

Italy4 sites, 4 recruiting

Musica In Gioco
Adelfia, Bari, 70010
Andrea Gargiulo, Prof., +393381931953, MusicaInGioco@gmail.com
Recruiting
University of Bari
Bari, Bari, 70121
Mariangela Lippolis, +393284154560, mariangela.lippolis@uniba.it
Recruiting
Centro Servizi per la famiglia Libertà
Bari, Bari, 70122
Mariella Cataldo, (+39) 080 558 0129, csfliberta@occusol.org
Recruiting
ANAS Puglia (Associazione Nazionale di Azione Sociale)
Bari, Bari, 70125
Luigi Favia, +39 327 758 6556, anaspromozionesocialepuglia@gmail.com
Recruiting

Other trials in Italy

About this study

Official title: A Multi-domain Intervention to Constrast Cognitive Decline in Healthy Aging

Does engaging in multiple activities, including music, slow the degeneration of perceptual and cognitive functions?
Is it possible to foster beneficial brain changes even during aging?
Can regularly attending social contexts reduce the risk of loneliness and provide fulfillment in later life? Researchers will compare participants involved in the multidomain intervention, including music, to another active group carrying out several activities but without music, and to a passive control group.

Participants will:

Participate in the programs for 9 months;
Be tested three times (before and after the intervention, and at a 6-month follow-up);
Keep a weekly diary of the actual time spent in their activities.

Read the detailed description

Brain-Derived Neurotrophic Factor (BDNF) plays a crucial role in neuroplasticity, supporting brain health throughout life and even during aging. This longitudinal study investigates the impact of a 9-month multidomain intervention, including choral practice, on BDNF levels, as well as audiometric and neuropsychological outcomes, in older adults, who are also assessed for their multidimensional frailty, based on their physical, cognitive, and nutritional conditions. BDNF levels, along with geriatric, neuropsychological, audiometric, and neurophysiological measures, are collected via saliva samples both pre- and post-intervention. For the longitudinal analyses of BDNF, up to 60 elderly individuals will be recruited from several recreational centers located in Southern Italy. Of these, one group will engage in a multidomain program that includes choir, physical, intellectual, and manual activities. The other two control groups will engage either in sporadic non-musical activities or no activity, or in various non-musical activities. Participation in all activities will be monitored via diaries.

The researchers' primary goal is to investigate whether engaging in physical, cognitive, and social activities can enhance neuroplasticity, as measured by BDNF levels, to counteract aspects of multidimensional frailty (as assessed by the multidimensional prognostic score, MPI) in the aging population. Secondly, the researchers aim to relate changes in BDNF levels to perceptual and cognitive functions and psychosocial well-being. Although previous studies point out the positive effects of musical training and active aging on brain health, the scarcity of longitudinal research on BDNF effects in older individuals leaves the issue open. Moreover, the researchers aim to test whether non-invasive, accessible saliva-based BDNF measurements, despite some reliability limitations, could offer indications of neuroprotection in aging.

Conditions: Healthy Volunteer Study
Being tested: Multidomain Intervention, General activities
Keywords: BDNF, aging, multidomain intervention, music training, neuroplasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multidomain InterventionOther
The intervention is distinguished by its multidomain approach combining cognitive, social, and musical activities through choir participation, targeting holistic cognitive and emotional benefits, unlike active controls (general activities) and passive controls (no activities).
General activitiesOther
Participants will carry out a series of physical, manual and/or intellectual activities (e.g., horticulture, physical activities, theatre, learning programs etc.) but not musical activities

Study groups in NCT06767410
Study group	Role	What they receive
Multidomain group	Experimental	Participants who undergo regularly a series of activities involving different domains (e.g., physical activity, choir, horticulture etc.). Receives: Other: Multidomain Intervention
Active control group	Active comparator	Participants who undergo regularly a series of activities but not musical acivities Receives: Other: General activities
Passive control group	No intervention	Participants who undergo any activity or just sporadic activities

What is being measured

The primary outcome is the main question the study is designed to answer.

Brain-Derived Neurotrophic Factor (BDNF)
BDNF levels detected in saliva
Measured: Baseline, 9 months and 6 months follow-up
Cognitive functioning
Assessed using the Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005), a widely used screening tool for cognitive impairment that evaluates multiple cognitive domains, including attention, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Description of the task:
The MoCA consists of 30 items, covering various cognitive tasks such as word recall, trail-making, and visuospatial exercises.
Unit of Measure:
Raw score, ranging from 0 to 30, where higher scores indicate better cognitive functioning. A score below 26 typically indicates mild cognitive impairment.
Interpretation:
Higher scores reflect better cognitive performance. The measure is commonly used to detect cognitive deficits and track cognitive changes over time.
Measured: Baseline, 9 months and 6 months follow-up
Fluid Intelligence
Assessed with computerized Matrix Reasoning (Condon \& Revelle 2014; Chan \& Kosinski, 2015), a test that contains stimuli that are similar to those used in Raven's Progressive Matrices.
Task Description:
The stimuli are 3 × 3 arrays of geometric shapes with one of the nine shapes missing. Participants are instructed to identify which of the six geometric shapes presented as response choices will best complete the stimuli. In each round the stimulus disappears after 120 s, leaving only the response options visible for the participant.
Unit of Measure:
The score is calculated as a standardized z-score, with a mean of 0 and no fixed minimum or maximum value. Scores can be both positive or negative, depending on the participant's performance relative to the sample distribution.
Interpretation:
Higher positive scores indicate better-than-average performance in reasoning ability, while negative scores indicate below-average performance. This measure is suitable for evaluating individual
Measured: Baseline, 9 months and 6 months follow-up
Hearing Threshold
Assessed using a liminal tonal audiometric test, which determines the participant's minimum acoustic intensity perceivable at different tonal field frequencies.
Description of the task:
Participants are tested across a range of frequencies in a soundproof booth to identify the lowest intensity level at which they can detect a tone.
Unit of Measure:
Hearing threshold in decibels hearing level (dB HL), measured for each frequency. Lower thresholds (i.e., lower dB HL values) indicate better hearing sensitivity.
Interpretation:
Lower dB HL values indicate better hearing ability. The results are used to identify any hearing loss and its severity at specific frequencies.
Measured: Baseline, 9 months and 6 months follow-up
Intelligibility
Assessed using speech audiometry, which evaluates the participant's ability to recognize and understand spoken words in a controlled environment.
Description of the task:
Participants are presented with vocal material (e.g., phonemes, logotomes, words, sentences) in a silent booth and must repeat what they hear.
Unit of Measure:
Percentage of correctly recognized words, where higher percentages indicate better speech intelligibility.
Interpretation:
Higher percentages indicate better verbal recognition and understanding. This measure helps assess speech comprehension in quiet conditions.
Measured: Baseline, 9 months and 6 months follow-up
Speech in noise ability
Assessed using a Matrix Sentence Test, which evaluates speech comprehension under noisy conditions.
Description of the task:
Participants are presented with 5-word sentences along with a background noise (competition noise) and must repeat the sentences. The test adapts after each response by adjusting the difficulty (increasing or decreasing the noise level) until the participant reaches a 50% comprehension threshold.
Unit of Measure:
Signal Reception Threshold (SRT) in decibels (dB). The SRT represents the difference between the word volume and the noise volume at which the participant understands 50% of the words.
Interpretation:
Lower SRT values indicate better speech comprehension under noisy conditions.
Measured: Baseline, 9 months and 6 months follow-up
Auditory brainstem responses (ABR)
Measure of the neural activity along the auditory pathway in response to a brief acoustic stimulus.
Description of the task:
Short-duration acoustic stimuli (100 μs clicks) are presented independently to each ear at 90 dBnHL, with filters set at 100 and 3000 Hz. The resulting waveforms represent the activity of the auditory nerve and brainstem.
Unit of Measure:
Latencies of waves I-V in milliseconds (ms). Longer latencies may indicate abnormalities in the auditory pathway.
Interpretation:
Normal latencies indicate typical auditory nerve and brainstem function. Abnormal latencies may suggest issues such as hearing loss or neural conduction delays.
Measured: Baseline, 9 months and 6 months follow-up
P300 auditory cortical potentials
Measures higher-level auditory processing and cognitive responses to auditory stimuli.
Description of the task:
Tones (50 ms) are presented at a rate of 1.1/s, with standard stimuli occurring 80% of the time and target stimuli randomly occurring 20% of the time. Participants are required to detect and respond to the target stimuli. The P300 response is recorded using electrodes in the same montage as for the ABR.
Unit of Measure:
P300 latency in milliseconds (ms) and P300 amplitude in microvolts (µV). Shorter latencies and higher amplitudes indicate better cognitive and auditory processing.
Interpretation:
Shorter P300 latencies and higher amplitudes suggest more efficient auditory and cognitive processing. Prolonged latencies or reduced amplitudes may indicate deficits in auditory or cognitive functions.
Measured: Baseline, 9 months and 6 months follow-up
Multidimensional Frailty
Assessed using the Selfy-MPI (Pilotto et al., 2019), a self-administered digital tool via the Portable-MPI app.
Description:
The Selfy-MPI evaluates frailty across several dimensions, including:
Functional status and independence: Measured by ADLs and IADLs.
Mobility: Assessed through self-reported ability to move independently.
Cognitive condition: Evaluated with a brief cognitive test.
Nutritional status: Measured using the Mini Nutritional Assessment (MNA).
Comorbidity: Assessed using the Cumulative Illness Rating Scale (CIRS).
Medication use: Evaluated via the ATC classification for polypharmacy.
Living situation: Assessed by questions on living arrangements.
Unit of Measure:
Composite score ranging from 0 to 1, where:
0-0.33: Low frailty risk 0.34-0.66: Moderate frailty risk 0.67-1.00: Severe frailty risk
Interpretation:
Higher scores indicate greater frailty.
Measured: Baseline, 9 months and 6 months follow-up
Socio-psychological well being
Assessed using the Flourishing Scale (Diener et al., 2010), a self-report measure that evaluates various domains, including relationships, purpose in life, and self-esteem.
Description of the task:
Participants rate 8 statements related to different aspects of their well-being (e.g., "I lead a purposeful and meaningful life") on a scale from 1 (Strongly disagree) to 7 (Strongly agree).
Unit of Measure:
The total score ranges from 8 to 56, with higher scores indicating greater psychological flourishing and well-being.
Interpretation:
Higher scores reflect better overall well-being, life satisfaction, and psychological functioning.
Measured: Baseline, 9 months and 6 months follow-up

Secondary outcomes (6)

Physical activity
Assessed using the Global Physical Activity Questionnaire (GPAQ), developed by Armstrong \& Bull (2006) for the World Health Organization (WHO) to measure physical activity levels across different domains of daily life.
Description of the task:
The GPAQ collects self-reported information on physical activity in three domains:
Work-related physical activity Travel to and from places (active transport) Recreational physical activity It also includes a section on sedentary behavior.
Unit of Measure:
Physical activity is reported in Metabolic Equivalent of Task (MET) minutes per week.
Sedentary behavior is reported in minutes per day spent sitting.
Interpretation:
Higher MET minutes indicate greater physical activity levels, while higher sedentary minutes indicate lower activity and greater sedentary behavior.
Measured: Baseline, 9 months and 6 months follow-up
Cognitive Reserve
Assessed using the Cognitive Reserve Index Questionnaire (CRIq), developed by Nucci, Mapelli \& Mondini (2012), a tool designed to estimate an individual's cognitive reserve based on their lifetime activities.
Description of the task:
The CRIq collects self-reported information across three domains:
Education (CRI-E): Years of formal education and training. Working activity (CRI-W): Type and duration of work experience, categorized by cognitive demand.
Leisure time activities (CRI-L): Participation in cognitively stimulating activities during leisure time (e.g., reading, social engagement, cultural activities).
Unit of Measure:
The questionnaire provides a total Cognitive Reserve Index (CRI) score, along with sub-scores for each domain (CRI-E, CRI-W, CRI-L). The total score is standardized, with higher values indicating greater cognitive reserve.
Interpretation:
Higher CRI scores suggest a higher level of cognitive reserve, which is associated with better cognitive functioning and r
Measured: Baseline, 9 months and 6 months follow-up
Melody Discrimination
Assessed using the Melody Discrimination Test (MDT), an adaptive task based on a three-alternative forced-choice (3-AFC) melodic discrimination paradigm, developed by Harrison et al. (2017). The test evaluates participants' ability to discriminate between similar melodies by identifying the melody with a single altered note.
Description of the task:
In each trial, participants hear three versions of the same melody. Two of the versions (lures) have the same interval structure, while the third version (the odd-one-out) contains a single altered note.
Participants are required to identify the odd-one-out melody by first identifying the most similar pair and then selecting the melody that is different.
The difficulty of the items is adaptively adjusted by manipulating the length of the melodies. In this study, the test consists of 18 items.
Unit of Measure:
Standardized z-score, with a mean of 0 and no fixed minimum or maximum value. Scores can be positive or negative, depending on the
Measured: Baseline, 9 months and 6 months follow-up
Mistuning Perception
Assessed using the Mistuning Perception Test (MPT) (Larrouy-Maestri et al., 2019), which evaluates the ability to detect mistuning in musical extracts.
Description of the task: In each trial, participants are presented with two versions of a musical excerpt-one "in tune" and one "out of tune"-and must identify the out-of-tune version. The stimulus material consists of short excerpts (6-12 s in length) from pop music performances (obtained from MedleyDB; Bittner et al., 2017) for which the vocal track was pitch-shifted relative to the instrumental tracks. Each musical extract has a vocalist singing the main melodic line and an instrumental accompaniment. Out-of-tune extracts are produced by adding a constant pitch shift to the vocal line
Unit of Measure:
Standardized z-score with a mean of 0, where scores can be positive or negative.
Interpretation:
Higher scores indicate better mistuning perception.
Measured: Baseline, 9 months and 6 months follow-up
Emotion Discrimination
Assessed using the Emotion Discrimination Test (EDT) (MacGregor \& Müllensiefen, 2019), an adaptive test that evaluates the ability to distinguish emotions conveyed by musical fragments.
In each trial, participants are presented with two versions of a melody and must identify which fragment corresponds to a specific target emotion (anger, happiness, sadness, or tenderness). Excerpts differ between trials in terms of musical features such as length, instrument, melody, target emotion and comparison emotion, and item difficulty is assessed with regard to the contribution of these features.
Unit of Measure:
Standardized z-score, with a mean of 0, where scores can be positive or negative.
Interpretation:
Higher scores indicate better ability to discriminate emotions in music.
Measured: Baseline, 9 months and 6 months follow-up
Rhythmic Ability
Assessed using the Rhythm Ability Test (RAT) (MacGregor et al., 2022), an adaptive test that evaluates rhythmic perception. Participants hear a rhythm composed of high-pitched and low-pitched sounds and must select the image that correctly represents the rhythm, where sounds are visually indicated by squares of different colors in two rows.
Description of the task:
The rhythms are made up of high-pitched and low-pitched sounds. High-pitched and low-pitched sounds are represented in each picture with two rows of squares of two different colors placed at the top row (to indicate high-pitched sounds) and at the bottom row (to indicate low-pitched sounds). The tasks are presented according to a progressive increasing difficulty, and the stimuli are made up of 4, 8, and 16 sounds (quarter, eights, sixteenths notes).
Unit of Measure:
Standardized z-score, with a mean of 0, where scores can be positive or negative.
Interpretation:
Higher scores indicate better rhythmic ability.
Measured: Baseline, 9 months and 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 2025Dec 2027

First posted9 Jan 2025
Study start1 Oct 2025 (estimated)
Primary completion1 Jun 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Healthy Volunteer StudyStudies 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06767410
Sponsor's protocol ID: ET-23-27
Acronym: MultiMusic
Status last verified: Jan 2025
First submitted: 23 Dec 2024
Last updated: 9 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will share anonymized derived data, including salivary BDNF levels and neurophysiological data, but not the biological saliva samples due to logistical limitations, ethical constraints regarding participant consent, and the adequacy of the derived data to support further analyses. This ensures transparency while respecting ethical and practical considerations.

Publications

Wang X, Soshi T, Yamashita M, Kakihara M, Tsutsumi T, Iwasaki S, Sekiyama K. Effects of a 10-week musical instrument training on cognitive function in healthy older adults: implications for desirable tests and period of training. Front Aging Neurosci. 2023 Aug 15;15:1180259. doi: 10.3389/fnagi.2023.1180259. eCollection 2023.
PubMed 37649718
Vrijen C, Schenk HM, Hartman CA, Oldehinkel AJ. Measuring BDNF in saliva using commercial ELISA: Results from a small pilot study. Psychiatry Res. 2017 Aug;254:340-346. doi: 10.1016/j.psychres.2017.04.034. Epub 2017 Apr 22.
PubMed 28525789
Veronese N, Noale M, Cella A, Custodero C, Smith L, Barbagelata M, Maggi S, Barbagallo M, Sabba C, Ferrucci L, Pilotto A. Multidimensional frailty and quality of life: data from the English Longitudinal Study of Ageing. Qual Life Res. 2022 Oct;31(10):2985-2993. doi: 10.1007/s11136-022-03152-9. Epub 2022 May 17.
PubMed 35579730
Seinfeld S, Figueroa H, Ortiz-Gil J, Sanchez-Vives MV. Effects of music learning and piano practice on cognitive function, mood and quality of life in older adults. Front Psychol. 2013 Nov 1;4:810. doi: 10.3389/fpsyg.2013.00810. eCollection 2013.
PubMed 24198804
Rosenberg A, Ngandu T, Rusanen M, Antikainen R, Backman L, Havulinna S, Hanninen T, Laatikainen T, Lehtisalo J, Levalahti E, Lindstrom J, Paajanen T, Peltonen M, Soininen H, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Solomon A, Kivipelto M. Multidomain lifestyle intervention benefits a large elderly population at risk for cognitive decline and dementia regardless of baseline characteristics: The FINGER trial. Alzheimers Dement. 2018 Mar;14(3):263-270. doi: 10.1016/j.jalz.2017.09.006. Epub 2017 Oct 19.
PubMed 29055814
Perus L, Busto GU, Mangin JF, Le Bars E, Gabelle A. Effects of preventive interventions on neuroimaging biomarkers in subjects at-risk to develop Alzheimer's disease: A systematic review. Front Aging Neurosci. 2022 Nov 24;14:1014559. doi: 10.3389/fnagi.2022.1014559. eCollection 2022.
PubMed 36506466
Pentikainen E, Kimppa L, Pitkaniemi A, Lahti O, Sarkamo T. Longitudinal effects of choir singing on aging cognition and wellbeing: a two-year follow-up study. Front Hum Neurosci. 2023 Jul 20;17:1174574. doi: 10.3389/fnhum.2023.1174574. eCollection 2023.
PubMed 37545597
Nazam F, Shaikh S, Nazam N, Alshahrani AS, Hasan GM, Hassan MI. Mechanistic insights into the pathogenesis of neurodegenerative diseases: towards the development of effective therapy. Mol Cell Biochem. 2021 Jul;476(7):2739-2752. doi: 10.1007/s11010-021-04120-6. Epub 2021 Mar 9.
PubMed 33687588
Nettiksimmons J, Simonsick EM, Harris T, Satterfield S, Rosano C, Yaffe K; Health ABC Study. The associations between serum brain-derived neurotrophic factor, potential confounders, and cognitive decline: a longitudinal study. PLoS One. 2014 Mar 26;9(3):e91339. doi: 10.1371/journal.pone.0091339. eCollection 2014.
PubMed 24670553
Moon SY, Kim S, Choi SH, Hong CH, Park YK, Na HR, Song HS, Park HK, Choi M, Lee SM, Chun BO, Lee JM, Jeong JH. Impact of Multidomain Lifestyle Intervention on Cerebral Cortical Thickness and Serum Brain-Derived Neurotrophic Factor: the SUPERBRAIN Exploratory Sub-study. Neurotherapeutics. 2022 Sep;19(5):1514-1525. doi: 10.1007/s13311-022-01276-x. Epub 2022 Aug 1.
PubMed 35915368
Mizoguchi Y, Yao H, Imamura Y, Hashimoto M, Monji A. Lower brain-derived neurotrophic factor levels are associated with age-related memory impairment in community-dwelling older adults: the Sefuri study. Sci Rep. 2020 Oct 5;10(1):16442. doi: 10.1038/s41598-020-73576-1.
PubMed 33020545
Marie D, Muller CAH, Altenmuller E, Van De Ville D, Junemann K, Scholz DS, Kruger THC, Worschech F, Kliegel M, Sinke C, James CE. Music interventions in 132 healthy older adults enhance cerebellar grey matter and auditory working memory, despite general brain atrophy. Neuroimage Rep. 2023 Mar 23;3(2):100166. doi: 10.1016/j.ynirp.2023.100166. eCollection 2023 Jun.
PubMed 40568451
MacAulay, R. K., Edelman, P., Boeve, A., Sprangers, N., & Halpin, A. (2019). Group music training as a multimodal cognitive intervention for older adults. Psychomusicology: Music, Mind, and Brain, 29(4), 180.
Lin FR, Ferrucci L, Metter EJ, An Y, Zonderman AB, Resnick SM. Hearing loss and cognition in the Baltimore Longitudinal Study of Aging. Neuropsychology. 2011 Nov;25(6):763-70. doi: 10.1037/a0024238.
PubMed 21728425
Lee S, Harada K, Bae S, Harada K, Makino K, Anan Y, Suzuki T, Shimada H. A non-pharmacological multidomain intervention of dual-task exercise and social activity affects the cognitive function in community-dwelling older adults with mild to moderate cognitive decline: A randomized controlled trial. Front Aging Neurosci. 2023 Mar 13;15:1005410. doi: 10.3389/fnagi.2023.1005410. eCollection 2023.
PubMed 36993908

Interested in taking part?

Elvira Brattico, Professor

+390805714702

elvira.brattico@uniba.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-domain Intervention to Constrast Cognitive Decline in Healthy Aging
ClinicalTrials.gov ID: NCT06767410
Acronym / sponsor ID: MultiMusic / ET-23-27
Conditions: Healthy Volunteer Study
Keywords: BDNF, aging, multidomain intervention, music training, neuroplasticity
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: University of BariUniversity, hospital or other
Study start: 1 Oct 2025 (estimated)
Primary completion: 1 Jun 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 9 Jan 2025 (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.

Does engaging in multiple activities, including music, slow the degeneration of perceptual and cognitive functions?
Is it possible to foster beneficial brain changes even during aging?
Can regularly attending social contexts reduce the risk of loneliness and provide fulfillment in later life? Researchers will compare participants involved in the multidomain intervention, including music, to another active group carrying out several activities but without music, and to a passive control group.

Participants will:

Participate in the programs for 9 months;
Be tested three times (before and after the intervention, and at a 6-month follow-up);
Keep a weekly diary of the actual time spent in their activities.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Multidomain group	Experimental	Other: Multidomain InterventionParticipants who undergo regularly a series of activities involving different domains (e.g., physical activity, choir, horticulture etc.).
Active control group	Active comparator	Other: General activitiesParticipants who undergo regularly a series of activities but not musical acivities
Passive control group	No intervention	–Participants who undergo any activity or just sporadic activities

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

Age ≥ 65
Living independently

Key exclusion criteria (2 listed)

Musical expertise
Severe cognitive or functional impairment

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
Multidomain InterventionThe intervention is distinguished by its multidomain approach combining cognitive, social, and musical activities through choir participation, targeting holistic cognitive and emotional benefits, unlike active controls (general activities) and passive controls (no activities).	Other	Multidomain group
General activitiesParticipants will carry out a series of physical, manual and/or intellectual activities (e.g., horticulture, physical activities, theatre, learning programs etc.) but not musical activities	Other	Active control group

Primary outcome

Brain-Derived Neurotrophic Factor (BDNF)
Time frame: Baseline, 9 months and 6 months follow-up
BDNF levels detected in saliva
Cognitive functioning
Time frame: Baseline, 9 months and 6 months follow-up
Assessed using the Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005), a widely used screening tool for cognitive impairment that evaluates multiple cognitive domains, including attention, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Description of the task: The MoCA consists of 30 items, covering various cognitive tasks such as word recall, trail-making, and visuospatial exercises. Unit of Measure: Raw score, ranging from 0 to 30, where higher scores indicate better cognitive functioning. A score below 26 typically indicates mild cognitive impairment. Interpretation: Higher scores reflect better cognitive performance. The measure is commonly used to detect cognitive deficits and track cognitive changes over time.
Fluid Intelligence
Time frame: Baseline, 9 months and 6 months follow-up
Assessed with computerized Matrix Reasoning (Condon \& Revelle 2014; Chan \& Kosinski, 2015), a test that contains stimuli that are similar to those used in Raven's Progressive Matrices. Task Description: The stimuli are 3 × 3 arrays of geometric shapes with one of the nine shapes missing. Participants are instructed to identify which of the six geometric shapes presented as response choices will best complete the stimuli. In each round the stimulus disappears after 120 s, leaving only the response options visible for the participant. Unit of Measure: The score is calculated as a standardized z-score, with a mean of 0 and no fixed minimum or maximum value. Scores can be both positive or negative, depending on the participant's performance relative to the sample distribution. Interpretation: Higher positive scores indicate better-than-average performance in reasoning ability, while negative scores indicate below-average performance. This measure is suitable for evaluating individual
Hearing Threshold
Time frame: Baseline, 9 months and 6 months follow-up
Assessed using a liminal tonal audiometric test, which determines the participant's minimum acoustic intensity perceivable at different tonal field frequencies. Description of the task: Participants are tested across a range of frequencies in a soundproof booth to identify the lowest intensity level at which they can detect a tone. Unit of Measure: Hearing threshold in decibels hearing level (dB HL), measured for each frequency. Lower thresholds (i.e., lower dB HL values) indicate better hearing sensitivity. Interpretation: Lower dB HL values indicate better hearing ability. The results are used to identify any hearing loss and its severity at specific frequencies.
Intelligibility
Time frame: Baseline, 9 months and 6 months follow-up
Assessed using speech audiometry, which evaluates the participant's ability to recognize and understand spoken words in a controlled environment. Description of the task: Participants are presented with vocal material (e.g., phonemes, logotomes, words, sentences) in a silent booth and must repeat what they hear. Unit of Measure: Percentage of correctly recognized words, where higher percentages indicate better speech intelligibility. Interpretation: Higher percentages indicate better verbal recognition and understanding. This measure helps assess speech comprehension in quiet conditions.
Speech in noise ability
Time frame: Baseline, 9 months and 6 months follow-up
Assessed using a Matrix Sentence Test, which evaluates speech comprehension under noisy conditions. Description of the task: Participants are presented with 5-word sentences along with a background noise (competition noise) and must repeat the sentences. The test adapts after each response by adjusting the difficulty (increasing or decreasing the noise level) until the participant reaches a 50% comprehension threshold. Unit of Measure: Signal Reception Threshold (SRT) in decibels (dB). The SRT represents the difference between the word volume and the noise volume at which the participant understands 50% of the words. Interpretation: Lower SRT values indicate better speech comprehension under noisy conditions.
Auditory brainstem responses (ABR)
Time frame: Baseline, 9 months and 6 months follow-up
Measure of the neural activity along the auditory pathway in response to a brief acoustic stimulus. Description of the task: Short-duration acoustic stimuli (100 μs clicks) are presented independently to each ear at 90 dBnHL, with filters set at 100 and 3000 Hz. The resulting waveforms represent the activity of the auditory nerve and brainstem. Unit of Measure: Latencies of waves I-V in milliseconds (ms). Longer latencies may indicate abnormalities in the auditory pathway. Interpretation: Normal latencies indicate typical auditory nerve and brainstem function. Abnormal latencies may suggest issues such as hearing loss or neural conduction delays.
P300 auditory cortical potentials
Time frame: Baseline, 9 months and 6 months follow-up
Measures higher-level auditory processing and cognitive responses to auditory stimuli. Description of the task: Tones (50 ms) are presented at a rate of 1.1/s, with standard stimuli occurring 80% of the time and target stimuli randomly occurring 20% of the time. Participants are required to detect and respond to the target stimuli. The P300 response is recorded using electrodes in the same montage as for the ABR. Unit of Measure: P300 latency in milliseconds (ms) and P300 amplitude in microvolts (µV). Shorter latencies and higher amplitudes indicate better cognitive and auditory processing. Interpretation: Shorter P300 latencies and higher amplitudes suggest more efficient auditory and cognitive processing. Prolonged latencies or reduced amplitudes may indicate deficits in auditory or cognitive functions.
Multidimensional Frailty
Time frame: Baseline, 9 months and 6 months follow-up
Assessed using the Selfy-MPI (Pilotto et al., 2019), a self-administered digital tool via the Portable-MPI app. Description: The Selfy-MPI evaluates frailty across several dimensions, including: Functional status and independence: Measured by ADLs and IADLs. Mobility: Assessed through self-reported ability to move independently. Cognitive condition: Evaluated with a brief cognitive test. Nutritional status: Measured using the Mini Nutritional Assessment (MNA). Comorbidity: Assessed using the Cumulative Illness Rating Scale (CIRS). Medication use: Evaluated via the ATC classification for polypharmacy. Living situation: Assessed by questions on living arrangements. Unit of Measure: Composite score ranging from 0 to 1, where: 0-0.33: Low frailty risk 0.34-0.66: Moderate frailty risk 0.67-1.00: Severe frailty risk Interpretation: Higher scores indicate greater frailty.
Socio-psychological well being
Time frame: Baseline, 9 months and 6 months follow-up
Assessed using the Flourishing Scale (Diener et al., 2010), a self-report measure that evaluates various domains, including relationships, purpose in life, and self-esteem. Description of the task: Participants rate 8 statements related to different aspects of their well-being (e.g., "I lead a purposeful and meaningful life") on a scale from 1 (Strongly disagree) to 7 (Strongly agree). Unit of Measure: The total score ranges from 8 to 56, with higher scores indicating greater psychological flourishing and well-being. Interpretation: Higher scores reflect better overall well-being, life satisfaction, and psychological functioning.

6 secondary outcomes

Physical activity
Time frame: Baseline, 9 months and 6 months follow-up
Cognitive Reserve
Time frame: Baseline, 9 months and 6 months follow-up
Melody Discrimination
Time frame: Baseline, 9 months and 6 months follow-up
Mistuning Perception
Time frame: Baseline, 9 months and 6 months follow-up
Emotion Discrimination
Time frame: Baseline, 9 months and 6 months follow-up
Rhythmic Ability
Time frame: Baseline, 9 months and 6 months follow-up

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
Background: PubMed 37649718Wang X, Soshi T, Yamashita M, Kakihara M, Tsutsumi T, Iwasaki S, Sekiyama K. Effects of a 10-week musical instrument training on cognitive function in healthy older adults: implications for desirable tests and period of training. Front Aging Neurosci. 2023 Aug 15;15:1180259. doi: 10.3389/fnagi.2023.1180259. eCollection 2023.
Background: PubMed 28525789Vrijen C, Schenk HM, Hartman CA, Oldehinkel AJ. Measuring BDNF in saliva using commercial ELISA: Results from a small pilot study. Psychiatry Res. 2017 Aug;254:340-346. doi: 10.1016/j.psychres.2017.04.034. Epub 2017 Apr 22.
Background: PubMed 35579730Veronese N, Noale M, Cella A, Custodero C, Smith L, Barbagelata M, Maggi S, Barbagallo M, Sabba C, Ferrucci L, Pilotto A. Multidimensional frailty and quality of life: data from the English Longitudinal Study of Ageing. Qual Life Res. 2022 Oct;31(10):2985-2993. doi: 10.1007/s11136-022-03152-9. Epub 2022 May 17.
Background: PubMed 24198804Seinfeld S, Figueroa H, Ortiz-Gil J, Sanchez-Vives MV. Effects of music learning and piano practice on cognitive function, mood and quality of life in older adults. Front Psychol. 2013 Nov 1;4:810. doi: 10.3389/fpsyg.2013.00810. eCollection 2013.
Background: PubMed 29055814Rosenberg A, Ngandu T, Rusanen M, Antikainen R, Backman L, Havulinna S, Hanninen T, Laatikainen T, Lehtisalo J, Levalahti E, Lindstrom J, Paajanen T, Peltonen M, Soininen H, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Solomon A, Kivipelto M. Multidomain lifestyle intervention benefits a large elderly population at risk for cognitive decline and dementia regardless of baseline characteristics: The FINGER trial. Alzheimers Dement. 2018 Mar;14(3):263-270. doi: 10.1016/j.jalz.2017.09.006. Epub 2017 Oct 19.
Background: PubMed 36506466Perus L, Busto GU, Mangin JF, Le Bars E, Gabelle A. Effects of preventive interventions on neuroimaging biomarkers in subjects at-risk to develop Alzheimer's disease: A systematic review. Front Aging Neurosci. 2022 Nov 24;14:1014559. doi: 10.3389/fnagi.2022.1014559. eCollection 2022.
Background: PubMed 37545597Pentikainen E, Kimppa L, Pitkaniemi A, Lahti O, Sarkamo T. Longitudinal effects of choir singing on aging cognition and wellbeing: a two-year follow-up study. Front Hum Neurosci. 2023 Jul 20;17:1174574. doi: 10.3389/fnhum.2023.1174574. eCollection 2023.
Background: PubMed 33687588Nazam F, Shaikh S, Nazam N, Alshahrani AS, Hasan GM, Hassan MI. Mechanistic insights into the pathogenesis of neurodegenerative diseases: towards the development of effective therapy. Mol Cell Biochem. 2021 Jul;476(7):2739-2752. doi: 10.1007/s11010-021-04120-6. Epub 2021 Mar 9.
Background: PubMed 24670553Nettiksimmons J, Simonsick EM, Harris T, Satterfield S, Rosano C, Yaffe K; Health ABC Study. The associations between serum brain-derived neurotrophic factor, potential confounders, and cognitive decline: a longitudinal study. PLoS One. 2014 Mar 26;9(3):e91339. doi: 10.1371/journal.pone.0091339. eCollection 2014.
Background: PubMed 35915368Moon SY, Kim S, Choi SH, Hong CH, Park YK, Na HR, Song HS, Park HK, Choi M, Lee SM, Chun BO, Lee JM, Jeong JH. Impact of Multidomain Lifestyle Intervention on Cerebral Cortical Thickness and Serum Brain-Derived Neurotrophic Factor: the SUPERBRAIN Exploratory Sub-study. Neurotherapeutics. 2022 Sep;19(5):1514-1525. doi: 10.1007/s13311-022-01276-x. Epub 2022 Aug 1.
Background: PubMed 33020545Mizoguchi Y, Yao H, Imamura Y, Hashimoto M, Monji A. Lower brain-derived neurotrophic factor levels are associated with age-related memory impairment in community-dwelling older adults: the Sefuri study. Sci Rep. 2020 Oct 5;10(1):16442. doi: 10.1038/s41598-020-73576-1.
Background: PubMed 40568451Marie D, Muller CAH, Altenmuller E, Van De Ville D, Junemann K, Scholz DS, Kruger THC, Worschech F, Kliegel M, Sinke C, James CE. Music interventions in 132 healthy older adults enhance cerebellar grey matter and auditory working memory, despite general brain atrophy. Neuroimage Rep. 2023 Mar 23;3(2):100166. doi: 10.1016/j.ynirp.2023.100166. eCollection 2023 Jun.
Individual participant dataSharing planned: Yes. We will share anonymized derived data, including salivary BDNF levels and neurophysiological data, but not the biological saliva samples due to logistical limitations, ethical constraints regarding participant consent, and the adequacy of the derived data to support further analyses. This ensures transparency while respecting ethical and practical considerations.

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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.

Elvira Brattico, Professor contact

+390805714702

elvira.brattico@uniba.it

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multidomain Intervention and General activities in people with Healthy Volunteer Study, run by University of Bari at 4 sites in Italy.

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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elvira Brattico, Professor (+390805714702, elvira.brattico@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain-Derived Neurotrophic Factor (BDNF) (time frame: Baseline, 9 months and 6 months follow-up). The study lists 10 primary outcomes in all. 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 NCT06767410, which also lists 31 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 9 Jan 2025.