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ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients (ALMUTH)

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ClinicalTrials.gov Identifier: NCT03444181
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : November 12, 2018
Sponsor:
Collaborators:
NORCE Norwegian Research Centre AS
Bergen Municipality
Information provided by (Responsible Party):
Stefan Koelsch, University of Bergen

Study Description
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Brief Summary:
Music has powerful effects on memory in patients with neurodegenerative diseases. However, although there is anecdotal evidence for beneficial effects of active music interventions in patients with Alzheimer's disease (AD), there is lack of high-quality research investigating this issue, and the cognitive, emotional, and social factors that contribute to potentially beneficial effects of music making in AD patients are largely unknown. In a randomised controlled intervention trial, a cohort of AD patients will undergo twelve months of music lessons specifically tailored for AD patients. Structural and functional magnetic resonance imaging (MRI) will be used to determine changes in brain age (as compared to two control groups), and voxel-based morphometry will be computed to determine contributions of different factors of the music intervention (cognitive, emotional, and social) to plastic changes of brain morphology, and a potential deceleration of brain atrophy. In addition, quality of life of patients. In cooperation with the Bergen municipality, and a strong network of national and international partners, the neurocognitive music therapy will be implemented, involving training of music therapists, and communication of results to patients, patient groups, and therapists.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild Cognitive Impairment MCI With Increased Risk for Alzheimer Disease Behavioral: Music lessons Behavioral: Training intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Music lessons Behavioral: Music lessons
Also described as neurocognitive music therapy. Singing lessons will be provided once a week for a period of 12 months by a person with a qualification in music therapy, or by a person with a different relevant qualification (e.g. psychology and music teaching) under the supervision of a music therapist. Additionally, participants will have the opportunity to meet regularly (1-2 times per month) as a choir to sing the song they have learned together in a group.
Active Comparator: Training intervention Behavioral: Training intervention
Cognitive training that is comparable in scope and extent to the music lessons, but not using music. Group training sessions will be provided once a week for a period of 12 months by a person with a qualification in physiotherapy or occupational therapy. Group activities may include group tours such as mountain hikes and the like (about 2 times per month) and will follow an established program for the elderly.
No Intervention: No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Brain age [ Time Frame: 12 months ]
    MRI-derived estimation of the deviation of a person's brain age from the chronological age of that same person, in months

  2. Depression symptoms [ Time Frame: 12 months ]
    Sum score of the Geriatric Depression Scale (GDS; 15 yes/no items; possible range of scores 0-15; higher scores indicating more severe depression symptoms)


Secondary Outcome Measures :
  1. Living independently at home [ Time Frame: 12 months and up to 5 years ]
    Whether a person still lives at home or has moved to a care home (time-to-event data)

  2. Language abilities [ Time Frame: 12 months ]
    Word Learning Test

  3. Sensori-motor functions [ Time Frame: 12 months ]
    Finger Tapping Test

  4. Activities of daily living [ Time Frame: 12 months ]
    Instrumental Activities of Daily Living (IADL)

  5. Disease progression [ Time Frame: 12 months ]
    Mini-Mental State Examination (MMSE)

  6. Cognitive functioning [ Time Frame: 12 months ]
    Stroop test, online version

  7. Integrity of fibre tracts [ Time Frame: 12 months ]
    Estimated from Diffusion Tensor Imaging (DTI)

  8. Resting-state functional connectivity [ Time Frame: 12 months ]
    Functional connectivity (posterior versus anterior/ventral) in default mode network (DMN)

  9. Working alliance [ Time Frame: 6 months ]
    Working Alliance Inventory-Short Revised (WAI-SR)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer Disease
  • Living independently at home (not in a care home or similar aged care facility)
  • Able to complete questionnaires in Norwegian
  • Able to undergo MRI scans
  • Able to attend interventions and assessments in the area of Bergen, Norway
  • Has given informed consent

Exclusion Criteria:

  • Hearing impairment that cannot be mended by hearing aids
  • Conditions that hinder MRI scans, such as claustrophobia or metal objects in body (e.g. pacemakers)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444181


Contacts
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Contact: Stefan Koelsch, PhD +47 55 58 62 31 stefan.koelsch@uib.no
Contact: Birthe K Flo, Cand. PhD +47 55 58 62 09 Birthe.Flo@uib.no

Locations
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Norway
Bergen Municipality Recruiting
Bergen, Hordaland, Norway
Contact: Marianne Solbakk, PhD         
Sponsors and Collaborators
University of Bergen
NORCE Norwegian Research Centre AS
Bergen Municipality
Investigators
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Principal Investigator: Stefan Koelsch, PhD University of Bergen
More Information
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Additional Information:
Project website  This link exits the ClinicalTrials.gov site

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Responsible Party: Stefan Koelsch, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT03444181     History of Changes
Other Study ID Numbers: RCN 260576
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders