NCT05038579

Brief Summary

Dementia is a neurodegenerative syndrome that leads to cognitive deficits and, consequently, affects functionality and quality of life. This study will explore the clinical impact of a customized cognitive stimulation program, using Musiquence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

May 4, 2021

Last Update Submit

September 4, 2021

Conditions

Dementia

Keywords

DementiaCognitive stimulationMusiquenceMusicReminiscenceAugmented Reality

Outcome Measures

Primary Outcomes (2)

  • Mini-Mental State Examination (Cognitive Screening) (MMSE)

    Change from baseline in the MMSE. Minimum of 0 points and maximum of 30 points. Higher scores mean better outcomes.

    Baseline, Post-intervention (7 weeks), Follow-up (3 months)

  • Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS - Cog)

    Change from baseline in the ADAS-Cog. Minimum of 0 points and maximum of 68 points. Higher scores mean worse outcomes.

    Baseline, Post-intervention (7 weeks), Follow-up (3 months)

Secondary Outcomes (8)

  • Quality of Life - Alzheimer's Disease (QoL - AD)

    Baseline, Post-intervention (7 weeks), Follow-up (3 months)

  • Kettler Laurent Thierreau (KLT)

    Baseline, Post-intervention (7 weeks), Follow-up (3 months)

  • Symbol Search - Weschler Adult Inteligence Scale 3rd edition (SR)

    Baseline, Post-intervention (7 weeks), Follow-up (3 months)

  • Digital Symbol Coding - Weschler Adult Inteligence Scale 3rd edition (DSC)

    Baseline, Post-intervention (7 weeks), Follow-up (3 months)

  • Semantic and Phonemic Verbal Fluency (SPVF)

    Baseline, Post-intervention (7 weeks), Follow-up (3 months)

  • +3 more secondary outcomes

Study Arms (1)

Musiquence

EXPERIMENTAL

Dementia group was involved in a 14-session customized cognitive stimulation program, using Musiquence.

Procedure: Musiquence

Interventions

MusiquencePROCEDURE

The participants performed a customized cognitive stimulation program, that was implemented in an augmented reality format, using Musiquence.

Musiquence

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate stage of dementia (with formal diagnosis);
  • Ability to move upper limbs;
  • Maintained auditory acuity;
  • Relatively preserved language skills.

You may not qualify if:

  • Moderate to severe depressive symptomatology;
  • Moderate to severe anxious symptomatology;
  • Bedridden.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade da Madeira

Funchal, Madeira, 9020-105, Portugal

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor at the University of Madeira and Senior Researcher at NOVA-LINCS

Study Record Dates

First Submitted

May 4, 2021

First Posted

September 9, 2021

Study Start

September 1, 2019

Primary Completion

November 30, 2020

Study Completion

February 28, 2021

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

PT(1)