NCT04132193

Brief Summary

Correlation of musicality, brain atrophy in brain areas relevant for music processing and the stage of Alzheimer´s disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Status
unknown

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

Study Start

First participant enrolled

October 1, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 8, 2019

Last Update Submit

October 23, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Montreal Battery of Evaluation of Amusia

    Number of correct answers in three task collections (total 79 tasks)

    60 minutes

  • Brain atrophy in MRI scans

    Loss of volume in brain regions relevant for music processing and in the hippocampi estimated by voxel-based morphometry

    120 minutes

  • CERAD (Consortium for Establishing Registry of Alzheimer´s Disease)

    Level of cognitive impairment

    30 minutes

Secondary Outcomes (1)

  • Use of music in patient´s daily life

    30 minutes

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of Southwest Finland Hospital District

You may qualify if:

  • Diagnosed Alzheimer´s disease

You may not qualify if:

  • Other neurological comorbidity, substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Seppo Soinila, MD PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seppo Soinila, MD PhD

CONTACT

Pavel Zaitsev, B.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, chief physician

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 18, 2019

Study Start

October 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2021

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share