Dementia Clinical Trial
Official title:
Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia
This study evaluates the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in home and care home settings.
Status | Not yet recruiting |
Enrollment | 192 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Prior severe psychiatric illness or substance abuse - Major hearing or visual impairment |
Country | Name | City | State |
---|---|---|---|
Finland | Wilhelmiina Services | Helsinki |
Lead Sponsor | Collaborator |
---|---|
University of Helsinki | City of Helsinki, Helsinki University Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Association between baseline demographic and musical background factors and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages) | Demographic (e.g., age, gender, education) and musical (e.g., previous and current musical activity, music education) factors at baseline (data collected using interview / questionnaires). These data are used as predictors of treatment effects in the primary/secondary outcome measures. | Baseline | |
Other | Association between baseline music cognition indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages) | Different elements of music cognition (music perception, musical emotions, rhythmic timing, musical movement, singing) measured at baseline using questionnaires and short behavioural tasks. These data are used as predictors of treatment effects in the primary/secondary outcome measures. | Baseline | |
Other | Association between baseline ERP indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages) | Amplitude and latency of event-related potentials (ERPs) linked to auditory perception and memory in two passive auditory tasks measured at baseline using electroencephalography (EEG). These data are used as predictors of treatment effects in the primary/secondary outcome measures. | Baseline | |
Other | Association between baseline sMRI indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages) | Grey matter volume in cortical and subcortical brain regions measured at baseline using structural magnetic resonance imaging (sMRI: MPRAGE sequence). These data are used as predictors of treatment effects in the primary/secondary outcome measures. | Baseline | |
Other | Association between baseline dMRI indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages) | Structural connectivity of white matter tracts measured at baseline using diffusion magnetic resonance imaging (dMRI: HARDI sequence). These data are used as predictors of treatment effects in the primary/secondary outcome measures. | Baseline | |
Other | Association between baseline fMRI indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages) | Brain activation and connectivity at resting state and during music listening measured at baseline using functional magnetic resonance imaging (fMRI). These data are used as predictors of treatment effects in the primary/secondary outcome measures. | Baseline | |
Primary | 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 | Baseline and 3-month stage | |
Primary | 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 | Baseline and 3-month stage | |
Secondary | 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 | Baseline and 6-month stage | |
Secondary | 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 | Baseline and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage | |
Secondary | 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 | Baseline, 3-month stage and 6-month stage |
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