NCT06378372

Brief Summary

The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease. The key question is: Can pianistic practice influence the development of Alzheimer's disease? Participants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 18, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

AlzheimerNeuropsicologyMusicPianoRehabilitaciónMusic Theraphy

Outcome Measures

Primary Outcomes (8)

  • State of global deterioration

    GDS 1 - 7

    Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

  • Minimental Test

    0-24

    Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

  • RDRS-2 Rapid Disability Assessment Scale

    18-72

    Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

  • MONTREAL COGNITIVE ASSESSMENT (MOCA)

    0-30

    Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

  • WAIS-IV

    0-160

    Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

  • Behavioral disorders: BEHAVE-AD

    Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

  • NPI - CUMMINGS

    0-120

    Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

  • Evaluation of the caregiver's burden (Zarit test)

    0-88

    Pre-intervention, Post-intervention (after four weeks of intervention), Follow up after 6 month intervention.

Study Arms (1)

Grupo 0

EXPERIMENTAL

Group on which the pianistic intervention will be carried out

Behavioral: Music therapy based on piano learning

Interventions

The intervention will consist of pianistic training. Patients will receive piano classes adapted to their competence designed to achieve motor, sensory and behavioral control.

Grupo 0

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients in State of global deterioration Levels GDS 2 3 and 4.

You may not qualify if:

  • Other patients in GDS groups (not 2, 3 and 4)
  • The selected subject does not cooperate during intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de León

León, Castille and León, 24004, Spain

Location

Related Publications (15)

  • Alzheimer´s Association. (2020). 2020 Alzheimer´s Disease Facts and Figures. Alzheimer´s & Dementia: The Journal of the Alzheimer Association, 16(3), 391-460. Doi: 10.1002/alz.12068

    BACKGROUND
  • Baird A, Samson S. Memory for music in Alzheimer's disease: unforgettable? Neuropsychol Rev. 2009 Mar;19(1):85-101. doi: 10.1007/s11065-009-9085-2. Epub 2009 Feb 13.

    PMID: 19214750BACKGROUND
  • Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

    PMID: 7991117BACKGROUND
  • Hanna-Pladdy B, MacKay A. The relation between instrumental musical activity and cognitive aging. Neuropsychology. 2011 May;25(3):378-86. doi: 10.1037/a0021895.

    PMID: 21463047BACKGROUND
  • López O, Tratamiento farmacológico de la enfermedad de Alzheimer y otras demencias. (2015) Recuperado de: http://www.scielo.edu.uy/scielo.php?pid=S1688-423X2015000200003&script=sci_arttext&tlng=pt

    BACKGROUND
  • Maurer K, Maurer U. Alzheimer. La vida de un médico, la historia de una enfermedad. Madrid: Díaz de Santos; 2006.

    BACKGROUND
  • MSCBS. Ministerio de Sanidad, Consumo y Bienestar Social (2019) Plan integral de Alzheimer y otras Demencias (2019-2023) Recuperado de: https://mscbs.gob.es/profesionales/saludPublica/docs/Plan_Integral_Alzheimer_Octubre_2019.pdf

    BACKGROUND
  • NINDS. National Institute of Neurological Disorders and Stroke. (2019). Recuperado de: https://www.ninds.nih.gov/Disorders/All-Disorders/Alzheimers-Disease Information-Page

    BACKGROUND
  • Paxinos, G. y Mai, J. (2004). The human nervous system. Academic Press, Inc.

    BACKGROUND
  • Peretz I, Zatorre RJ. Brain organization for music processing. Annu Rev Psychol. 2005;56:89-114. doi: 10.1146/annurev.psych.56.091103.070225.

    PMID: 15709930BACKGROUND
  • Sclan S, Saillon A, Franssen E, et al. The behavior pathology in Alzheimer's disease ratings scale (BEHAVE-AD): reability and analisys of symptom category scores. Int J Geriatr Psychiatry, 1996; 11: 819-830.

    BACKGROUND
  • Scheltens P, Blennow K, Breteler MM, de Strooper B, Frisoni GB, Salloway S, Van der Flier WM. Alzheimer's disease. Lancet. 2016 Jul 30;388(10043):505-17. doi: 10.1016/S0140-6736(15)01124-1. Epub 2016 Feb 24.

    PMID: 26921134BACKGROUND
  • Sultzer DL, Levin HS, Mahler ME, High WM, Cummings JL. Assessment of cognitive, psychiatric, and behavioral disturbances in patients with dementia: the Neurobehavioral Rating Scale. J Am Geriatr Soc. 1992 Jun;40(6):549-55. doi: 10.1111/j.1532-5415.1992.tb02101.x.

    PMID: 1587970BACKGROUND
  • Tariot PN, Mack JL, Patterson MB, Edland SD, Weiner MF, Fillenbaum G, Blazina L, Teri L, Rubin E, Mortimer JA, et al. The Behavior Rating Scale for Dementia of the Consortium to Establish a Registry for Alzheimer's Disease. The Behavioral Pathology Committee of the Consortium to Establish a Registry for Alzheimer's Disease. Am J Psychiatry. 1995 Sep;152(9):1349-57. doi: 10.1176/ajp.152.9.1349.

    PMID: 7653692BACKGROUND
  • Valenzuela MJ, Sachdev P. Brain reserve and dementia: a systematic review. Psychol Med. 2006 Apr;36(4):441-54. doi: 10.1017/S0033291705006264. Epub 2005 Oct 6.

    PMID: 16207391BACKGROUND

MeSH Terms

Conditions

DementiaDementia, VascularMixed DementiasLewy Body DiseaseCognitive DysfunctionNervous System DiseasesNeurologic Manifestations

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCognition DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Franco-Castellanos, Sr

    Universidad de León

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Franco-Castellanos, Sr

CONTACT

Jesus Angel Seco-Calvo, Sr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: An intervention based on teaching the piano in an individualized way
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 22, 2024

Study Start

June 1, 2024

Primary Completion

August 1, 2024

Study Completion

June 1, 2025

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations