NCT03444181: ALMUTH

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

Active, enrolled NA Last updated 8 May 2024

What this trial tests

NA trial testing Music lessons in Alzheimer Disease in 136 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 April 2018

Primary endpoint
14 June 2024

14 June 2024

Quick facts

Lead sponsor	University of Bergen
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	136
Start date	11 April 2018
Primary completion	14 June 2024
Estimated completion	14 June 2024
Sites	1 location across Norway

Drugs / interventions tested

• Music lessons
• Training intervention

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• MCI With Increased Risk for Alzheimer Disease — all drugs for MCI With Increased Risk for Alzheimer Disease →

Sponsor

University of Bergen

Who can join

18 and older, any sex, with Alzheimer Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The promise of music therapy for Alzheimer's disease: A review.
   Matziorinis AM, Koelsch S. · · 2022 · cited 61× · PMID 35851957 · DOI 10.1111/nyas.14864
2. Study protocol for the Alzheimer and music therapy study: An RCT to compare the efficacy of music therapy and physical activity on brain plasticity, depressive symptoms, and cognitive decline, in a population with and at risk for Alzheimer's disease.
   Flo BK, Matziorinis AM, Skouras S, Sudmann TT, et al · · 2022 · cited 18× · PMID 35771851 · DOI 10.1371/journal.pone.0270682
3. A 12-month randomised pilot trial of the Alzheimer's and music therapy study: a feasibility assessment of music therapy and physical activity in patients with mild-to-moderate Alzheimer's disease.
   Matziorinis AM, Flo BK, Skouras S, Dahle K, et al · · 2023 · cited 6× · PMID 37076884 · DOI 10.1186/s40814-023-01287-1
4. Navigating the stages of objective memory impairment (SOMI) through the Papez circuit: hippocampal brain reserve, white matter microstructure, and structural network topology along the Alzheimer’s continuum
   Matziorinis AM, Leemans A, Skouras S, Koelsch S. · · 2023 · cited 1× · DOI 10.21203/rs.3.rs-3412028/v1
5. Study protocol for the Alzheimer and Music Therapy (ALMUTH) Study: a 12-month, Randomised Controlled Trial to Compare the Efficacy of Music Therapy and Physical Activity on Brain Plasticity, Depressive Symptoms, and Cognitive Decline, in a Population with and at Risk for Alzheime
   Flo BK, Matziorinis AM, Skouras S, Sudmann TT, et al · · 2022 · DOI 10.21203/rs.3.rs-1380534/v1
6. A 12-month Randomised Pilot Trial of the Alzheimer’s and Music Therapy Study: A Feasibility Assessment of Music Therapy and Physical Activity in Patients with Mild-to-Moderate Alzheimer’s Disease
   Matziorinis AM, Flo BK, Skouras S, Dahle K, et al · · 2022 · DOI 10.21203/rs.3.rs-1238008/v1