An interventional study of Music Therapy in Healthy Aging and Cognitive Impairment, sponsored by Middlesex University. Completed at 1 site in United Kingdom. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Middlesex University · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 137 studies in Cognitive Dysfunction with a site in United Kingdom — 36 open to participants now, 53 under way, 7 of them phase 3. Cognitive Dysfunction · United Kingdom.
Among the 137 studies in Cognitive Dysfunction with a site in United Kingdom, this one is the 27th largest by enrollment of the 88 interventional ones that give a count, is one of 15 that started in 2022, is one of 50 with no phase, and was the 70th registered.
3,876 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
Browse Cognitive Dysfunction studies →36 of the 137 studies in Cognitive Dysfunction with a site in United Kingdom are open now. Recruiting first, the newest first:
University College, London · Sites in United Kingdom
Ages 55+
University of Edinburgh · Sites in United Kingdom
Ages 18+
University of Ulster · Sites in United Kingdom
Ages 50+ · Healthy volunteers
Prima Mente · Sites in United Kingdom
Ages 50+
King's College Hospital NHS Trust · Sites in United Kingdom
Ages 18–65
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 753 Cognitive Dysfunction studies recruiting now, 364 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 260 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
137 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 17 · Phase 3 14 · Phase 4 1
First in 2004; this study’s year is marked. 15 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 210 is above the median of 64 across 2,797 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 69 across the 88 interventional studies, 100 across the 49 observational. Of the 71 that completed or were terminated, 20 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
44 of 137 have an industry lead sponsor. The 10 most frequent:
Middlesex University is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Middlesex University has 2 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
8 of the studies in Cognitive Dysfunction with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT06207942Region SkaneStepcare Extended Follow-up Substudy | 2027-01 |
| NCT03507257Indiana UniversityLongitudinal Early-onset Alzheimer's Disease Study Protocol | 2027-01-01 |
| NCT06604104University of EdinburghVisual Frailty in Ageing | 2027-01-11 |
| NCT07466446University of EdinburghPost Intensive Care Accelerometery to Study and Support Recovery Outcomes | 2027-02-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 137 studies in Cognitive Dysfunction with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The number of older people living with cognitive impairment or dementia has increased the need for simple, inexpensive interventions to improve the quality of life for such individuals and their families. Policy-makers sensitive to issues associated with mental health challenges in aging have embraced social prescribing, and a wealth of research has flourished to study non-pharmacological forms of preventative intervention. Can music-therapy(MT) be one of them? Different studies demonstrated that music stimulates a range of cognitive and social functions. However, scientific studies assessing the value of MT for those who need support in later life are limited, and rigorous research is required to generate robust scientific evidence. The focus of this study is on developing novel forms of intervention for older adults who are healthy or experiencing mild-to-moderate cognitive decline, aiming at [i]understanding whether MT could be used in preventive programs to support cognitive functions, [ii]identifying the best match between types of MT and levels of cognitive decline. Moreover, recent developments of Robotic-Assistance-Technologies offer opportunities to explore how such technologies may be used to contribute to older adults wellbeing when integrated within care routines to facilitate MT delivery.
Spanning across three-studies, the investigators will examine psychosocial benefits of 5-month MT interventions (one2one, small-group MT, large-group MT) in healthy older adults and impaired older adults in care homes, compared to standard care. This latter group will receive MT afterwards. Further, researchers will investigate whether Robotic-Assistance-Technologies may enrich MT interventions and have additional benefits for the participants and translatability for community-based services.
In order to measure these effects, psychological (cognitive functions, wellbeing, quality of life) and physiological (hormonal, cardiovascular \& brain activity) measures will be compared before/after the intervention.
The study will elucidate relationships between different types of MT and benefits to participants wellbeing, cognitive functions \& social engagement, as well as the impact of robotic assistive technologies in public health services and social care.
The following objectives are addressed:
[Oi] Identifying a consistent set of convergent measures for the reliable assessment of cognition/well-being in MT studies integrating psychological measures with biomarkers; [Oii] Implementing robust MT protocols benefitting cognitive functions/well-being in ageing individuals with varying cognitive ability; [Oiii] Comparing the outcomes of one2one/small-group/large-group MT intervention in function of participants' cognitive abilities (ranging from healthy ageing to moderate impairment); [Oiv] Devising, implementing and testing a robotic platform associated with MT to facilitate therapists/caregivers' work through novel forms of interaction with ageing individuals, and potential translatability to communities.
Our research questions/hypotheses are:
[H1] Will MT benefits healthy, mildly and moderately impaired 65+ in outcome measures? MT > standard care.
[H2] Which MT treatment (one2one/small group/large group) is more effective in function of older adults' cognitive level? Best outcomes predicted as follows: healthy 65+ with small-group MT; for mildly impaired 65+, one2one = small-group MT\<large group; moderately impaired 65+ with one2one MT.
[H3] Will improvements in cognitive functions derived from MT be associated with psychophysiological biomarkers? Convergent measures will be identified linking cognitive, behavioural and physiological improvement.
[H4] What are the benefits of MT for caregivers? A reduction in participant psychiatric and depressive symptoms will correspond to caregivers' workload and stress perception decrease.
[H5] Are there benefits from enriching MT with robotic technology? Specifically, the investigators hypothesize that a) the robot will have the capability of delivering interactive music training sessions, with the support of caregivers not specialised in MT and b) the continuous monitoring provided by the robotic platform will enhance the information available to therapists/caregivers without significantly burdening them.
MusiCare aims are:
[Ai] Provide care-homes, communities and policy-makers with clear guidelines concerning the utility, suitability and cost-effectiveness of Music Therapy (MT) interventions (one2one vs small-group vs large group) as a prevention/rehabilitation method suitable for social prescribing and support for positive ageing.
[Aii] Provide music therapists with robust protocols, new tests specifically designed to work through musical tasks (Music Cognitive Test).
[Aiii] Provide scholars/practitioners with a range of objective measures to select from, depending on their needs, in order to evaluate MT interventions in ageing.
[Aiv] Explore how the assistive robotic technologies can enrich MT in care-home settings by empowering care-home staff with a new active role in assisting rehabilitative activities as well as facilitating inter-generational communication between families and ageing relatives.
[Av] Increase public awareness about healthy ageing, and arts \& wellbeing.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1\) Weekly individual (one2one) Music Therapy intervention lasting 5 months (n=20 sessions)
Behavioral: Music Therapy
2\) Weekly small group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions)
Behavioral: Music Therapy
3\) Weekly Large group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions)
Behavioral: Music Therapy
Passive control, not attending any music-related activity
Music therapy is a non-pharmacological intervention, in which music and its elements are used professionally as an intervention in medical, educational, and everyday environments with individuals, groups, families, or communities who seek to optimize their quality of life and improve their physical, social, communicative, emotional, intellectual, and spiritual health and wellbeing. This therapy has shown to provide significant benefits for individuals with cognitive decline living in care homes, enhancing social-cognitive functions and reducing behavioural symptoms (Brotons \& Koger, 2000; Hsu et al., 2015; Zhang et al., 2017).
General cognitive functions change from baseline/post (i.e., time 0/+5 months)
Mini-Mental State Examination (MMSE, Folstein et al., 1975): A world standardized tool for screening general cognitive function which allows the client to be placed on a cognitive functioning scale. This test is usually used to follow the course of a disease or for monitoring the response to a specific treatment, as in this case.
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Music related cognitive function change from baseline/post (i.e., time 0/+5 months)
Music Cognitive Test (MCT, Mangiacotti, 2019; - et al., 2019b) A music-based cognitive test to measure cognitive functions typically stimulated by rehabilitative music interventions.
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Attentional functions change from baseline/post (i.e., time 0/+5 months)
TMT-A (Reitan \& Wolfoson, 1985) The test assesses selective attention and psychomotor speed.
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Executive and spatial-cognitive abilities change from baseline/post (i.e., time 0/+5 months)
Tangled Figure Test (Arcara et al., 2011) The test wants to evaluate participant's ability to perform figure-background discrimination and inhibition on the answers already provided as well as to recognize the contours of the figures. Mainly it is a test of visual recognition, but it requires the ability to reorganize a complex visual pattern in order to identify an increasing number of figures. Provides information on spatial-cognitive abilities, and executive and naming difficulties.
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Quality of Life change from baseline/post (i.e., time 0/+5 months)
• Quality of Life in Alzheimer's Disease (Logsdon et al., 1999); The test measure quality of life in dementia. Rating is got from both the participant and the caregiver.
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Mood Index change from baseline/post (i.e., time 0/+5 months)
• Cornell Scale for Depression in Dementia (CSDD, Alexopoulos, Abrams, Young, \& Shamoian, 1988); This test is specifically designed to screen depressive symptoms in older adults with dementia and cognitive impairment. It is an interviewer-administered scale relying on information from caregivers and clinician's observations.
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Neuro-psychiatric symptoms change from baseline/post (i.e., time 0/+5 months)
• Neuro-Psychiatric Inventory (NPI, Cummings, 1994) A tool that provides information on the presence of psychopathology in people with brain disorders. The NPI was developed for people with Alzheimer's disease and other dementias, but it may be useful in the assessment of behavioural changes in other conditions.
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Cognitive reserve
· Cognitive Reserve Index Questionnaire (CRI-Q, Nucci, Mapelli, Mondini, 2012). A tool used to quantify, in a standardized model, cognitive reserve through an interview to the participant or to the caregiver. The questionnaire collects demographic information regarding the school curriculum, work and type of free-time activities. These three different indices (CRI-School, CRI-Work and CRI-Free Time) are then combined into a single "Index of Cognitive Reserve". This test is useful in the research setting to balance study groups, as occur this project.
Time frame: Baseline (i.e., time 0)
Wellbeing of Older People scale
(WOOP; Hackert et al., 2020) Used as a general index of wellbeing, the scale asks participants to rate nine factors (physical health, mental health, social contacts, support, acceptance and resilience, feeling useful, independence, financial security, and living situation) according to their importance for overall wellbeing. Higher scores reflect greater self-perceived wellbeing
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Sleep Quality Index
Measured with the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) to assess overall sleep quality. This self-report questionnaire comprises seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction."
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Salivary Hormones index (cortisol/DHEA ratio) change from baseline/post (i.e., time 0/+5 months)
Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant: * Before lunchtime (11.00am to 12.30am); * Before dinner (4pm to 5pm); * Evening (from 7pm to 8pm).
Time frame: Baseline vs. post- intervention period (time 0/+5-months)
Salivary Hormones index (cortisol/DHEA ratio) change from baseline/mid-intervention(i.e., time 0/+10 weeks)
Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant: * Before lunchtime (11.00am to 12.30am); * Before dinner (4pm to 5pm); * Evening (from 7pm to 8pm).
Time frame: Baseline vs. mid-intervention period (time 0/+10 weeks)
Salivary Hormones index (cortisol/DHEA ratio) change from mid-/post-intervention (i.e., 10weeks/5 months)
Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant: * Before lunchtime (11.00am to 12.30am); * Before dinner (4pm to 5pm); * Evening (from 7pm to 8pm).
Time frame: Mid-intervention period (10 weeks) vs. post-intervention (5 months)
RSA change from baseline/post (i.e., time 0/+5 months)
• Respiratory sinus arrhythmia (RSA): 5 min resting state
Time frame: Baseline and post- intervention period (time 0/+5-months)
EEG change from baseline/post (i.e., time 0/+5 months)
• Neural tracking of natural speech and musical sound: EEG measures of cortical activity (Di Liberto et al., 2015, 2020) - 8 electrodes, 15 minutes.
Time frame: Baseline and post- intervention period (time 0/+5-months)
Plan to share: Yes — An anonymised dataset will be created with all the cognitive and physiological data collected from participants that will give consent to share their anonymised data.
Supporting information: Study protocol, Statistical analysis plan
Time frame: August 2025
Access criteria: Middlesex University FigShare
Ran from Apr 2022 to primary completion in Apr 2024, 24 months.
Of 1,449 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 24 months is below that.
Counting every sponsor, half of 1,518 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Middlesex University