NCT02670993

Brief Summary

Alzheimer Disease (AD), characterized by cognitive and psycho-behavioral troubles, concerns essentially 65 years old and older patients. Antalgic and psychotropic treatments have adverse effects in old people, and have to be used carefully. To improve the pain support and limit the drug consumption, it is possible to perform therapies without drugs. Among them, musical intervention represents an interesting complementary support, to deal with physical and moral pain in AD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

January 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

January 25, 2016

Last Update Submit

September 19, 2016

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Score at the EVS = simplified visual scale

    To evaluate the efficacy of the singing sessions on pain in Alzheimer's Disease patients (beginning stage), by comparison with a control activity (painting), on pain intensity.

    Month 1

Secondary Outcomes (2)

  • Score at the EN (digital scale) scale

    Month 1

  • Score at the BPI (Brief Pain Inventory) scale : Brief pain Inventory

    Month 1

Study Arms (2)

Control group : Singing sessions.

EXPERIMENTAL

Patients will participate to singing working sessions. They will continue to take their usual treatments during the study period.

Behavioral: Singing sessions.

Control group : Painting sessions.

ACTIVE COMPARATOR

Patients will continue to participate to painting work sessions, and to take their usual treatments during the study.

Behavioral: Painting sessions.

Interventions

Singing sessions.BEHAVIORAL

Patients will be in singing work groups, and will participate to these sessions during 12 weeks, with one session per week of 2 hours.

Control group : Singing sessions.
Painting sessions.BEHAVIORAL

Patients will be in painting groups, they will participate to this work session during 12 weeks, with one session of 2 hours per week.

Control group : Painting sessions.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 60 years old and older, fulfilling the diagnostic criteria for Alzheimer's disease to a mild dementia stage, or mild cognitive impairment
  • Delay of at least one month between the diagnosis and the early work sessions
  • If use of psychotropic drugs, they must be stabilized for 3 month
  • If analgesics consumption level 2 or 3 they must be stabilized for 1 month
  • With a score greater than or equal to 22 on the simplified visual scale (EVS) pain.
  • Visual capabilities , auditory and oral or written expression in French language sufficient for conducting clinical and neuropsychological evaluations;
  • MMSE \> 20
  • Patient affiliated or entitled to a social security scheme

You may not qualify if:

  • Patient with a different etiology of cognitive disorder that of Alzheimer's disease
  • Patients with severe disease, progressive or unstable nature which may interfere with the evaluation variables
  • Patient with blindness or deafness could compromise its assessment
  • Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices civils de Lyon

Lyon, 69000, France

Location

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • ROUCH Isabelle, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 2, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)