NCT04573712

Brief Summary

60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital and from the " Fragilily " Platform of the Nice University Hospital. After verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity. Afterwards, participants will have to complete assessments and questionnaires to evaluate apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale). Regarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game 'Tap-piscine'). The total duration of the evaluation is a maximum of 2 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

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

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

September 28, 2020

Last Update Submit

March 20, 2026

Conditions

ApathyFatigue

Outcome Measures

Primary Outcomes (1)

  • comparison of Fatigue Severity Scale scores between apathetic and non-apathetic subjects.

    the minimum score is 9 (worse outcome) and the maximum score is 63 (better outcome)

    at inclusion

Study Arms (1)

Fatigue Severity Scale scores assessment

EXPERIMENTAL

Fatigue Severity Scale scores assessment

Other: Follow up and Assessment

Interventions

Follow up and AssessmentOTHER

each patient should wear an actigraph during a week and will be do some tests during 2hours (6min walk, apathy inventory, fatigue severity scale etc...)

Fatigue Severity Scale scores assessment

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men or women aged between 65 and 85 years old coming for consultation at the RMC and the Fragility Platform
  • DSM-5 diagnosis: minor neurocognitive disorders
  • Subject must read and write in French.
  • Subject must be registered in the national social security scheme.
  • Ability to sign free and informed consent.
  • For the 'apathetic' group:
  • \- Presence of apathy/emotional symptoms: at least 2 criteria according to the diagnostic criteria for apathy and a score higher than 8.5 in the MBI affective dimension.
  • For the 'non-apathetic' group:
  • \- Absence of apathy/emotional symptoms: no criteria according to the diagnostic criteria for apathy and a score of less than 8.5 in the MBI affective dimension.

You may not qualify if:

  • Motor or sensory disabilities likely to interfere with the tests.
  • Presence of major psychiatric disorders (e.g., schizophrenia, major depressive episode, bipolar disorder)
  • Patient under guardianship, curatorship or under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Memoire Ressources et Recherche, CHU de Nice

Nice, 06000, France

Location

Related Publications (1)

  • Daumas L, Zory R, Robert P, Manera V. Apathetic patients with neurocognitive disorders are more fatigued and fatigable. Aging Clin Exp Res. 2022 Sep;34(9):2237-2241. doi: 10.1007/s40520-022-02146-4. Epub 2022 May 24.

    PMID: 35608793RESULT

MeSH Terms

Conditions

LethargyFatigue

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Philippe ROBERT, PU-PH

    CHU de NICE, Centre Mémoire Ressources et Recherches

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

January 14, 2021

Primary Completion

December 21, 2021

Study Completion

December 21, 2021

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)