Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611878
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Memory for Music Individual Intensive Musical Training in Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Memory for Music Effects of Individual Intensive Musical Training Based on Singing in Non-musicians with Alzheimers Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M4M
Brief Summary:
This project called Memory for Music focuses on the increasing number of people worldwide living with dementia especially Alzheimers disease AD AD typically starts with memory problems and eventually affects daily activities Active music interventions especially singing have shown positive effects on mood behavior and quality of life for people with dementia but their impact on cognition is not well understood The project aims to address this gap by studying the effects of learning new songs on cognitive behavioral and brain functioning
The study will involve home-dwelling adults aged 65 or older with AD from Argentina Austria and Norway Participants will undergo 5 months of intensive musical training twice a week and 5 months of minimal training once a month in a random order with a 2-month break in between The interventions include learning new songs with a personal music teacher General cognition will be measured using the Alzheimers Disease Assessment Scale - Cognitive ADAS-cog and memory for music will be assessed through various methods including behavioral tasks and brain responses EEG Mood will also be evaluated in each session
The goal is to include 113 participants to ensure reliable detection of meaningful effects The study will explore how mood and memory for music contribute to changes in cognitive abilities and whether these effects vary based on factors such as sex age AD stage or previous musical training and general education The project emphasizes collaboration between researchers service providers and users to ensure the studys relevance and applicability
The study will involve home-dwelling adults aged 65 or older with AD from Argentina Austria and Norway Participants will undergo 5 months of intensive musical training twice a week and 5 months of minimal training once a month in a random order with a 2-month break in between The interventions include learning new songs with a personal music teacher General cognition will be measured using the Alzheimers Disease Assessment Scale - Cognitive ADAS-cog and memory for music will be assessed through various methods including behavioral tasks and brain responses EEG Mood will also be evaluated in each session
The goal is to include 113 participants to ensure reliable detection of meaningful effects The study will explore how mood and memory for music contribute to changes in cognitive abilities and whether these effects vary based on factors such as sex age AD stage or previous musical training and general education The project emphasizes collaboration between researchers service providers and users to ensure the studys relevance and applicability
Detailed Description:
The number of people living with dementia is increasing and is high in low middle and high-income countries Alzheimers disease AD the most common type of dementia manifests itself initially with cognitive impairment in memory domains and later affects all activities of daily living Active music interventions particularly singing can help to improve mood behaviour problems and quality of life Too little is known about their effects on cognition although some promising studies exist The M4M project aims to fill this gap by measuring effects of learning new songs on clinical behavioural and brain functioning Specifically M4M aims to examine changes in general cognitive functioning and memory for music in non-musician adults with AD undergoing intensive individual musical training based on singing novel songs compared to minimal training
Home-dwelling adults with AD 65 years or older in 3 countries Argentina Austria Norway will receive 5 months of intensive intervention 2xweek and 5 months of minimal intervention 1xmonth in random order with a 2-month break in between Interventions will entail learning new songs with an individual music teacher At the end of each intervention period general cognition will be measured with the Alzheimers Disease Assessment Scale - Cognitive ADAS-cog by a person who is unaware of the intervention received Memory for music will be tested with observations behavioural tasks and brain responses EEG Mood will be assessed in each session The investigators aim to include 113 participants this will help us to reliably detect clinically meaningful effects The investigators will also examine how mood and memory for music lead to changes in cognitive abilities and whether effects depend on sex age AD stage or previous musical training or general education M4M will be conducted in close collaboration between academic researchers service providers and service users to ensure relevance and applicability
Behavioural assessment will be conducted by the instructors and by external evaluators at specific points of the musical training Mood will be assessed using a 5-point emoji scale and Sense of Familiarity with the current song will be estimated using a scale that takes into account verbal and behavioural cues both measures were developed for the purpose of this study
EEG measures will be collected while participants listen to both unknown melodies and melodies they have learned during the intervention period and the investigators wish to assess whether in-key violations in known songs will elicit an N400-like event related potential If participants develop musical semantic memory through our intervention the investigators expect them to show this N400-like component to in-key violations in familiarized melodies ie those melodies that are introduced and learned during our intervention but only after the intervention If an N400 component is detectable during these in-key violations of a newly learned song it will indicate memory of the new song even if the participant is unable to adhere to a behavioural task or display an observable sense of familiarity The in-key violations will be introduced at multiple places throughout each melody which will consist of at least 32 bars A total of 10 melodies will be played for each participant of which half are learned in an intervention period familiarizedto be familiarized In each of the melodies the investigators will include at least 8 in-key violations ERPs in response to these in-key violations will be compared to ERPs in response to unchanged notes in structurally similar places in each melody
Home-dwelling adults with AD 65 years or older in 3 countries Argentina Austria Norway will receive 5 months of intensive intervention 2xweek and 5 months of minimal intervention 1xmonth in random order with a 2-month break in between Interventions will entail learning new songs with an individual music teacher At the end of each intervention period general cognition will be measured with the Alzheimers Disease Assessment Scale - Cognitive ADAS-cog by a person who is unaware of the intervention received Memory for music will be tested with observations behavioural tasks and brain responses EEG Mood will be assessed in each session The investigators aim to include 113 participants this will help us to reliably detect clinically meaningful effects The investigators will also examine how mood and memory for music lead to changes in cognitive abilities and whether effects depend on sex age AD stage or previous musical training or general education M4M will be conducted in close collaboration between academic researchers service providers and service users to ensure relevance and applicability
Behavioural assessment will be conducted by the instructors and by external evaluators at specific points of the musical training Mood will be assessed using a 5-point emoji scale and Sense of Familiarity with the current song will be estimated using a scale that takes into account verbal and behavioural cues both measures were developed for the purpose of this study
EEG measures will be collected while participants listen to both unknown melodies and melodies they have learned during the intervention period and the investigators wish to assess whether in-key violations in known songs will elicit an N400-like event related potential If participants develop musical semantic memory through our intervention the investigators expect them to show this N400-like component to in-key violations in familiarized melodies ie those melodies that are introduced and learned during our intervention but only after the intervention If an N400 component is detectable during these in-key violations of a newly learned song it will indicate memory of the new song even if the participant is unable to adhere to a behavioural task or display an observable sense of familiarity The in-key violations will be introduced at multiple places throughout each melody which will consist of at least 32 bars A total of 10 melodies will be played for each participant of which half are learned in an intervention period familiarizedto be familiarized In each of the melodies the investigators will include at least 8 in-key violations ERPs in response to these in-key violations will be compared to ERPs in response to unchanged notes in structurally similar places in each melody
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None