NCT02840045

Brief Summary

The purpose of this study is to use a new method to differentiate mnesic abilities of early alzheimer patients and patients with a depressive disorder. This method is based on the recording of cerebral activity while patients listen to familiar, unfamiliar and newly-learned music.

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
30

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

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

February 20, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

3.5 years

First QC Date

July 12, 2016

Last Update Submit

August 8, 2017

Conditions

Alzheimer DiseaseDepression

Keywords

electroencephalography (EEG)

Outcome Measures

Primary Outcomes (1)

  • Amplitude of event-related potentials

    Measurements of the amplitude of event-related potentials with electroencephalography at day one for familiar and unfamiliar songs and after 2 weeks for newly learned songs

    day 1 for familiar and unfamiliar songs and day 14 for newly learned songs

Secondary Outcomes (1)

  • Spectral power

    day 1 for familiar and unfamiliar songs and day 14 for newly learned songs

Study Arms (3)

Alzheimer patients

EXPERIMENTAL

Cerebral measurements from high-density electroencephalography are recorded in Alzheimer patients. The same protocol is applied in the 3 arms

Device: high-density electroencephalography

patients with a depressive disorder

EXPERIMENTAL

Cerebral measurements from high-density electroencephalography are recorded in patients with a depressive disorder. The same protocol is applied in the 3 arms

Device: high-density electroencephalography

Healthy controls

ACTIVE COMPARATOR

Cerebral measurements from high-density electroencephalography are recorded in healthy controls

Device: high-density electroencephalography

Interventions

high-density electroencephalographyDEVICE

Musical stimulation during electroencephalography recording

Alzheimer patientsHealthy controlspatients with a depressive disorder

Eligibility Criteria

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

You may qualify if:

  • Being right-handed
  • recorded consent
  • For Alzheimer patients: Mini Mental Status Examination (MMSE) score \>= 18
  • For patients with a depressive disorder : Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) and Montgomery-Asberg depression rating scale (MADRS) score \>= 25
  • For healthy controls : no cognitive deficit, MADRS score \< 25, no depressive disorder according to DSM IV

You may not qualify if:

  • Auditory deficit
  • contraindication to a high-density electroencephalography exam
  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Besançon

Besançon, Franche-Comte, 25000, France

RECRUITING

Related Publications (1)

  • Gabriel D, Wong TC, Nicolier M, Giustiniani J, Mignot C, Noiret N, Monnin J, Magnin E, Pazart L, Moulin T, Haffen E, Vandel P. Don't forget the lyrics! Spatiotemporal dynamics of neural mechanisms spontaneously evoked by gaps of silence in familiar and newly learned songs. Neurobiol Learn Mem. 2016 Jul;132:18-28. doi: 10.1016/j.nlm.2016.04.011. Epub 2016 Apr 27.

    PMID: 27131744BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDepression

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Pierre Vandel, MD, PhD

    Service de psychiatrie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien Gabriel, PhD

CONTACT

0033381219148dgabriel@chu-besancon.fr

Magali Nicolier, PhD

CONTACT

0033381219007mnicolier@chu-besancon.fr

Study Design

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

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 21, 2016

Study Start

February 20, 2015

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

FR(1)