ClinicalTrials.Veeva

Menu

The Effects of Apathy on Different Forms of Fatigue (FAME1)

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Apathy
Fatigue

Treatments

Other: Follow up and Assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT04573712
20-PP-20

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

65 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

57 participants in 1 patient group

Fatigue Severity Scale scores assessment
Experimental group
Description:
Fatigue Severity Scale scores assessment
Treatment:
Other: Follow up and Assessment

Trial contacts and locations

1

Loading...

Central trial contact

philippe ROBERT, PU-PH; Valéria MANERA, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems