DementiaNCT05520268
Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia
A study testing Conventional music therapy (CMT) and Digital music rehabilitation (DMR) in people with Dementia, run by University of Helsinki at 1 site in Finland.
Trial summary
This study evaluates the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in home and care home settings. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Conventional music therapy (CMT) and Digital music rehabilitation (DMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2022to 31 Dec 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed dementia (according to International Classification of Diseases [ICD] criteria), which is mild [Clinical Dementia Rating (CDR) score: 0.5-1, Global Deterioration Scale (GDS) score: 3-4], moderate (CDR: 2, GDS: 4-6), or severe (CDR: 3, GDS: 6-7) dementia
- Age ≥ 60 years
- Finnish-speaking (or bilingual; the study is performed in Finnish)
- Stable physical and somatic condition (no major changes in psychotropic medication during the last 3 months)
- Physically and cognitively able to take part in the intervention and assessments.
Who cannot join
- Prior severe psychiatric illness or substance abuse
- Major hearing or visual impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
University of Helsinki / Faculty of Medicine / Department of Psychology
Helsinki, 00014
Teppo Särkämö, PhD, +358505399065, teppo.sarkamo@helsinki.fi
About this study
This study evaluates the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in home and care home settings.
Read the detailed description
Rationale: In persons with dementia (PWDs), music-based interventions have shown positive effects on emotional, behavioural and cognitive symptoms as well as on psychological well-being and quality of life. Despite the evidence for the efficacy of music in PWDs, many issues surround the practicalities of music interventions, especially regarding their applicability, scalability, and optimization across the dementia care continuum. Moreover, the individual factors affecting the treatment outcomes of music-based interventions remain largely unexplored in dementia.
Aims: The purpose of this randomized controlled trial (RCT) is to determine the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in both home and care home settings. Specifically, the RCT seeks to determine (i) can conventional music therapy (CMT) and digital music rehabilitation (DMR) enhance or support cognitive function, mood, and quality of life in dementia compared to standard care; (ii) how does the efficacy of CMT and DMR differ in the different stages of dementia; and (iii) how do baseline demographic factors (e.g., age, gender, education), musical factors (musical background, music cognition) and neural factors (e.g., extent of neuropathology, preservation of music networks) affect the efficacy of the music interventions.
Methods: Participants are 192 PWDs across the dementia care continuum (PWDs with mild-moderate dementia living at home and PWDs with moderate-severe dementia living in care homes; N=96 each). Following a three-arm parallel-group RCT design, the PWDs living at home and at care homes are randomized into three groups (CMT, DMR, standard care; N=32 each]. The CMT and DMR comprise passive and active engagement with music over 10 weeks (2x60 min sessions/week), implemented either by a music therapist (CMT) or using a novel digital music content service (DMR). To investigate the efficacy of the music interventions, participants complete measures of cognitive functioning (neuropsychological tests) and mood and quality of life (questionnaires, clinical scales), which are assessed at three time points: baseline (pre-intervention), 3-month stage (post-intervention) and 6-month stage (follow-up). Additionally, family member and caregivers of PWDs are asked to answer questionnaires on the psychological well-being of the PWD (informant-report) and themselves (self-report). To explore the individual musical and neural factors that may affect the efficacy of music interventions, participants also complete a musical assessment battery as well as electroencephalography (EEG) and structural and functional MRI (s/fMRI) measurements at baseline.
- Conditions
- Dementia
- Being tested
- Conventional music therapy (CMT), Digital music rehabilitation (DMR)
- Keywords
- music therapy, music-based rehabilitation, digital intervention, cognitive functioning, memory, emotion, mood, quality of life, electroencephalography, magnetic resonance imaging
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional music therapy (CMT)Behavioural
CMT comprises both receptive and expressive musical activities (listening and reminiscing to music, singing, and moving to music) held in small groups (8 PWDs/group) for a duration of 10 weeks (2x60 min sessions/week) and led by a professional music therapist. For PWDs living in a care home, the CMT sessions are implemented as inpatient rehabilitation held at the care home. For PWDs living at home, the CMT sessions are implemented as outpatient rehabilitation held at a local day activity centre.
Digital music rehabilitation (DMR)Behavioural
DMR comprises both receptive and expressive musical activities (listening and reminiscing to music, singing, and moving to music) held in small groups (8 PWDs/group) for a duration of 10 weeks (2x60 min sessions/week) and implemented using a novel digital music content service called HILDA. In HILDA, there are a number of stand-alone musical programs hosted by a virtual presenter which the PWDs can follow and through which they can interact. The DMR sessions are moderated by an instructor (care home staff member or research assistant). For PWDs living in a care home, the DMR is implemented as live sessions held at the care home using a HILDA box connected to a TV screen and operated via a remote controller by the instructor. For PWDs living at home, the DMR is implemented as virtual sessions using a video communication platform that allows the instructor to stream and control the HILDA service and the participants to see and hear each other and interact.
| Study group | Role | What they receive |
|---|---|---|
| Conventional music therapy (CMT) | Experimental | Participants receive 10 weeks of CMT and standard care. Receives: Behavioral: Conventional music therapy (CMT) |
| Digital music rehabilitation (DMR) | Experimental | Participants receive 10 weeks of DMR and standard care. Receives: Behavioral: Digital music rehabilitation (DMR) |
| Standard care | No intervention | Participants receive only standard care. Standard care comprises normal care services received by the PWDs in the Finnish health care system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the MoCA score at 3-month stage
Montreal Cognitive Assessment (MoCA) score (range 0-30, higher score indicates better outcome), measures general cognitive function
Measured: Baseline and 3-month stage
Change from baseline in the CERAD total score at 3-month stage
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) total score (Chandler score, range 0-100, higher score indicates better outcome), measures general cognitive function
Measured: Baseline and 3-month stage
Secondary outcomes (28)
Change from baseline in the MoCA score at 6-month stage
Montreal Cognitive Assessment (MoCA) score (range 0-30, higher score indicates better outcome), measures general cognitive function
Measured: Baseline and 6-month stage
Change from baseline in the CERAD total score at 6-month stage
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) total score (Chandler score, range 0-100, higher score indicates better outcome), measures general cognitive function
Measured: Baseline and 6-month stage
Change from baseline in the MoCA Fluency score at 3-month and 6-month stages
Montreal Cognitive Assessment (MoCA) Fluency subtest score (phonemic fluency; min: 0, max: no upper limit, higher score indicates better outcome), measures language skills
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Fluency score at 3-month and 6-month stages
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Fluency subtest score (semantic fluency; min: 0, max: no upper limit, higher score indicates better outcome), measures language skills
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Naming score at 3-month and 6-month stages
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Naming subtest score (range: 0-15, higher score indicates better outcome), measures language skills
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Constructional Praxis score at 3-month and 6-month stages
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Constructional Praxis subtest score (range: 0-11, higher score indicates better outcome), measures visuoconstructive function
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Word List Learning score at 3-month and 6-month stages
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Learning subtest score (range: 0-30, higher score indicates better outcome), measures verbal learning
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Word List Recall score at 3-month and 6-month stages
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Recall subtest score (range: 0-10, higher score indicates better outcome), measures delayed spontaneous verbal recall
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Word List Recognition score at 3-month and 6-month stages
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Recognition subtest score (range: 0-20, higher score indicates better outcome), measures delayed cued verbal recall
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the WMS-IV Logical Memory I score at 3-month and 6-month stages
Wechsler Memory Scale IV (WMS-IV) Logical Memory I subtest score (range: 0-56, higher score indicates better outcome), measures immediate verbal recall
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the WMS-IV Logical Memory II score at 3-month and 6-month stages
Wechsler Memory Scale IV (WMS-IV) Logical Memory II subtest score (range: 0-28, higher score indicates better outcome), measures delayed verbal recall
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the IFS total score at 3-month and 6-month stages
INECO Frontal Screening (IFS) total score (range 0-30, higher score indicates better outcome), measures executive function and working memory
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the IFS Executive subscore at 3-month and 6-month stages
INECO Frontal Screening (IFS) Executive subscore (summary score of the Motor Series, Conflicting Instructions, Go-No Go, Proverbs and Hayling Test subtests, range 0-18, higher score indicates better outcome), measures executive function
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the IFS Working memory subscore at 3-month and 6-month stages
INECO Frontal Screening (IFS) Working memory subscore (summary score of the Digits Backward, Verbal Working Memory and Spatial Working Memory subtests, range 0-12, higher score indicates better outcome), measures working memory
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in autobiographical memory score at 3-month and 6-month stages
Custom-made autobiographical memory questionnaire, percentage score (range 0-100, higher score indicates better outcome; also qualitative data collected), measures subjective and objective autobiographical memory
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the MADRS score at 3-month and 6-month stages
Montgomery-Åsberg Depression Rating Scale (MADRS) score (range 0-60, higher score indicates worse outcome), measures depression symptoms
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the PROMIS Depression score at 3-month and 6-month stages
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scale score (range 8-40, higher score indicates worse outcome), measures depression symptoms
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the PROMIS Anxiety score at 3-month and 6-month stages
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scale score (range 8-40, higher score indicates worse outcome), measures anxiety symptoms
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the NPI-Q Severity score at 3-month and 6-month stages
Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity scale score (range 0-36, higher score indicates worse outcome), measures the severity of neuropsychiatric symptoms
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the NPI-Q Distress score at 3-month and 6-month stages
Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress scale score (range 0-60, higher score indicates worse outcome), measures the distress caused by the neuropsychiatric symptoms on caregivers
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the NPI-Q total score at 3-month and 6-month stages
Neuropsychiatric Inventory Questionnaire (NPI-Q) total score (range 0-180, calculated as Severity x Distress, higher score indicates worse outcome), measures the total level of neuropsychiatric symptoms
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the QoL-AD score at 3-month and 6-month stages
Quality of Life in Alzheimer's Disease (QoL-AD) score (range 15-60, higher score indicates better outcome), measures quality of life
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the EuroQol EQ-5D-5L Health index score at 3-month and 6-month stages
EuroQol EQ-5D-5L Health index score (range 0-1, higher score indicates better outcome), measures health-related quality of life
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the EuroQol EQ-5D-5L Health VAS score at 3-month and 6-month stages
EuroQol EQ-5D-5L Health VAS score (range 0-100, higher score indicates better outcome), measures general health
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the caregiver GHQ-12 score at 3-month and 6-month stages
General Health Questionnaire 12 (GHQ-12) score (caregiver self-report; range 0-36, higher score indicates worse outcome), measures stress and psychological well-being
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the caregiver ZBI-12 score at 3-month and 6-month stages
Zarit Burden Interview 12 (ZBI-12) score (caregiver self-report; range 0-48, higher score indicates worse outcome), measures caregiver burden
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the UWES-9 score at 3-month and 6-month stages
Utrecht Work Engagement Scale 9 (UWES-9) score (nurse self-report; range 0-54, higher score indicates better outcome), measures occupational well-being
Measured: Baseline, 3-month stage and 6-month stage
Change from baseline in the PCTB score at 3-month and 6-month stages
Professional Care Team Burden (PCTB) score (nurse self-report; range 0-40, higher score indicates worse outcome), measures professional care team burden
Measured: Baseline, 3-month stage and 6-month stage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, City of Helsinki
- Responsible party
- Principal investigator, Teppo Sarkamo, University of Helsinki
- Investigators
- Teppo Särkämö, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520268
- Sponsor's protocol ID
- 346211
- Other IDs
- 338448, 803466
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in articles, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia
- ClinicalTrials.gov ID
- NCT05520268
- Acronym / sponsor ID
- 346211
- Conditions
- Dementia
- Keywords
- music therapy, music-based rehabilitation, digital intervention, cognitive functioning, memory, emotion, mood, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, City of Helsinki
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Aug 2022 (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.
This study evaluates the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in home and care home settings.
Detailed description
Rationale: In persons with dementia (PWDs), music-based interventions have shown positive effects on emotional, behavioural and cognitive symptoms as well as on psychological well-being and quality of life. Despite the evidence for the efficacy of music in PWDs, many issues surround the practicalities of music interventions, especially regarding their applicability, scalability, and optimization across the dementia care continuum. Moreover, the individual factors affecting the treatment outcomes of music-based interventions remain largely unexplored in dementia.
Aims: The purpose of this randomized controlled trial (RCT) is to determine the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in both home and care home settings. Specifically, the RCT seeks to determine (i) can conventional music therapy (CMT) and digital music rehabilitation (DMR) enhance or support cognitive function, mood, and quality of life in dementia compared to standard care; (ii) how does the efficacy of CMT and DMR differ in the different stages of dementia; and (iii) how do baseline demographic factors (e.g., age, gender, education), musical factors (musical background, music cognition) and neural factors (e.g., extent of neuropathology, preservation of music networks) affect the efficacy of the music interventions.
Methods: Participants are 192 PWDs across the dementia care continuum (PWDs with mild-moderate dementia living at home and PWDs with moderate-severe dementia living in care homes; N=96 each). Following a three-arm parallel-group RCT design, the PWDs living at home and at care homes are randomized into three groups (CMT, DMR, standard care; N=32 each]. The CMT and DMR comprise passive and active engagement with music over 10 weeks (2x60 min sessions/week), implemented either by a music therapist (CMT) or using a novel digital music content service (DMR). To investigate the efficacy of the music interventions, participants complete measures of cognitive functioning (neuropsychological tests) and mood and quality of life (questionnaires, clinical scales), which are assessed at three time points: baseline (pre-intervention), 3-month stage (post-intervention) and 6-month stage (follow-up). Additionally, family member and caregivers of PWDs are asked to answer questionnaires on the psychological well-being of the PWD (informant-report) and themselves (self-report). To explore the individual musical and neural factors that may affect the efficacy of music interventions, participants also complete a musical assessment battery as well as electroencephalography (EEG) and structural and functional MRI (s/fMRI) measurements at baseline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional music therapy (CMT) | Experimental | Behavioral: Conventional music therapy (CMT)Participants receive 10 weeks of CMT and standard care. |
| Digital music rehabilitation (DMR) | Experimental | Behavioral: Digital music rehabilitation (DMR)Participants receive 10 weeks of DMR and standard care. |
| Standard care | No intervention | –Participants receive only standard care. Standard care comprises normal care services received by the PWDs in the Finnish health care system. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed dementia (according to International Classification of Diseases [ICD] criteria), which is mild [Clinical Dementia Rating (CDR) score: 0.5-1, Global Deterioration Scale (GDS) score: 3-4], moderate (CDR: 2, GDS: 4-6), or severe (CDR: 3, GDS: 6-7) dementia
- Age ≥ 60 years
- Finnish-speaking (or bilingual; the study is performed in Finnish)
- Stable physical and somatic condition (no major changes in psychotropic medication during the last 3 months)
- Physically and cognitively able to take part in the intervention and assessments.
Key exclusion criteria (2 listed)
- Prior severe psychiatric illness or substance abuse
- Major hearing or visual 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 |
|---|---|---|
| Conventional music therapy (CMT)CMT comprises both receptive and expressive musical activities (listening and reminiscing to music, singing, and moving to music) held in small groups (8 PWDs/group) for a duration of 10 weeks (2x60 min sessions/week) and led by a professional music therapist. For PWDs living in a care home, the CMT sessions are implemented as inpatient rehabilitation held at the care home. For PWDs living at home, the CMT sessions are implemented as outpatient rehabilitation held at a local day activity centre. | Behavioural | Conventional music therapy (CMT) |
| Digital music rehabilitation (DMR)DMR comprises both receptive and expressive musical activities (listening and reminiscing to music, singing, and moving to music) held in small groups (8 PWDs/group) for a duration of 10 weeks (2x60 min sessions/week) and implemented using a novel digital music content service called HILDA. In HILDA, there are a number of stand-alone musical programs hosted by a virtual presenter which the PWDs can follow and through which they can interact. The DMR sessions are moderated by an instructor (care home staff member or research assistant). For PWDs living in a care home, the DMR is implemented as live sessions held at the care home using a HILDA box connected to a TV screen and operated via a remote controller by the instructor. For PWDs living at home, the DMR is implemented as virtual sessions using a video communication platform that allows the instructor to stream and control the HILDA service and the participants to see and hear each other and interact. | Behavioural | Digital music rehabilitation (DMR) |
Primary outcome
Change from baseline in the MoCA score at 3-month stage
Time frame: Baseline and 3-month stage
Montreal Cognitive Assessment (MoCA) score (range 0-30, higher score indicates better outcome), measures general cognitive function
Change from baseline in the CERAD total score at 3-month stage
Time frame: Baseline and 3-month stage
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) total score (Chandler score, range 0-100, higher score indicates better outcome), measures general cognitive function
28 secondary outcomes
Change from baseline in the MoCA score at 6-month stage
Time frame: Baseline and 6-month stage
Change from baseline in the CERAD total score at 6-month stage
Time frame: Baseline and 6-month stage
Change from baseline in the MoCA Fluency score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Fluency score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Naming score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Constructional Praxis score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Word List Learning score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Word List Recall score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the CERAD Word List Recognition score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the WMS-IV Logical Memory I score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the WMS-IV Logical Memory II score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the IFS total score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the IFS Executive subscore at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the IFS Working memory subscore at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in autobiographical memory score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the MADRS score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the PROMIS Depression score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the PROMIS Anxiety score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the NPI-Q Severity score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the NPI-Q Distress score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the NPI-Q total score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the QoL-AD score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the EuroQol EQ-5D-5L Health index score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the EuroQol EQ-5D-5L Health VAS score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the caregiver GHQ-12 score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the caregiver ZBI-12 score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the UWES-9 score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
Change from baseline in the PCTB score at 3-month and 6-month stages
Time frame: Baseline, 3-month stage and 6-month stage
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 6 Feb 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in articles, after deidentification
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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.
Teppo Särkämö, PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional music therapy (CMT) and Digital music rehabilitation (DMR) in people with Dementia, run by University of Helsinki at 1 site in Finland.
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 5 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 6 Feb 2025. 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 Finland. 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 Anni Pitkäniemi, MA (+358503115872, anni.pitkaniemi@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the MoCA score at 3-month stage (time frame: Baseline and 3-month stage). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.