Memory for Music: Individual Intensive Musical Training in Alzheimer's Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Music training - intensive, Music training - minimal, Treatment as Usual (TAU).
- Кому может быть актуально
- Состояния в реестре: Alzheimer Disease. Базовые параметры: от 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Аргентина, Австрия, Норвегия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Memory for Music: Effects of Individual Intensive Musical Training Based on Singing in Non-musicians With Alzheimer's Disease
Обзор
This project, called Memory for Music, focuses on the increasing number of people worldwide living with dementia, especially Alzheimer's 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 Alzheimer's 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 study's relevance and applicability.
Подробное описание
The number of people living with dementia is increasing and is high in low, middle, and high-income countries. Alzheimer's 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 (2x/week) and 5 months of minimal intervention (1x/month), 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 Alzheimer's 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, i.e., 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 (familiarized/to 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.
Вмешательства
- Поведенческое Music training - intensive
Music training entails learning novel songs the participant chooses from a list. Songs are similar in complexity and length (number of words, high frequency words, harmony, musical complexity, length of verses and chorus). Offering a variety of songs allows to examine memory performance regardless of the specific song chosen. Sessions last 30 to 40 minutes, conducted based on a manual (1. mood observation; 2. warm-up; 3. teaching the chorus, observed liking of song; 4. singing entire chorus; 5. - Поведенческое Music training - minimal
Music training entails learning novel songs the participant chooses from a list. Songs are similar in complexity and length (number of words, high frequency words, harmony, musical complexity, length of verses and chorus). Offering a variety of songs allows to examine memory performance regardless of the specific song chosen. Sessions last 30 to 40 minutes, conducted based on a manual (1. mood observation; 2. warm-up; 3. teaching the chorus, observed liking of song; 4. singing entire chorus; 5. - Другое Treatment as Usual (TAU)
Medications, behavioural interventions and other treatments that participants may receive outside the study during the period of participation.
Первичные конечные точки
- ADAS-cog [Срок оценки: 0, 5, 7, 12 months]
- EEG-ERP N400 in response to music stimuli [Срок оценки: 0, 5, 7, 12 months]
Вторичные конечные точки (8)
- Mood [Срок оценки: Beginning and end of each training session, i.e. min. 1x/month, max. 10x/month, during months 1-5 and 7-12.]
- Sense of Familiarity with current song (Instructor) [Срок оценки: During each training session, i.e. min. 1x/month, max. 10x/month, during months 1-5 and 7-12.]
- Sense of Familiarity with current song (External Evaluator) [Срок оценки: At the end of selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.]
- Performance (chorus solo) [Срок оценки: During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.]
- Performance (chorus in context) [Срок оценки: During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.]
- Adverse events [Срок оценки: 5, 7, 12 months]
- Structural brain characteristics [Срок оценки: 0, 5 months]
- Functional brain connectivity metrics [Срок оценки: 0, 5 months]
Критерии участия
Критерии включения
- Diagnosis of Alzheimer's disease
- Home-dwelling
- Non-musician
Критерии исключения
- Non-Alzheimer dementia
- Living in care home
- History as a professional musician
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Норвегия · 4 центра
- University of Bergen — Bergen
- Haraldsplass Diakonale Sykehus — Bergen
- Kinn municipality — Florø
- Oslo municipality — Oslo
Аргентина · 1 центр
- Universidad de Ciencias Empresariales y Sociales — Buenos Aires
Австрия · 1 центр
- University of Vienna — Vienna
Публикации
- Lichtensztejn M, Cui AX, Geretsegger M, Lundervold AJ, Koelsch S, Pfabigan DM, Assmus J, Langeland E, Ruiz M, Tabernig C, Skogseth RE, Gold C. Memory for Music (M4M) protocol for an international randomised controlled trial: effects of individual intensive musical training based on singing in non-musicians with Alzheimer's disease. BMJ Open. 2025 Oct 20;15(10):e095136. doi: 10.1136/bmjopen-2024-09 PMID 41120149
Идентификаторы
NCT: NCT06611878 · 106684 · 344215