The Effects of Apathy on Different Forms of Fatigue | NCT04573712

Studies
The Effects of Apathy on Different Forms of Fatigue

NCT04573712

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Mar 24, 2026Actual

Enrollment

57Actual

Phase

Not Applicable

Conditions

Apathy
Fatigue

Interventions

Follow up and Assessment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2021Actual

Primary Completion Date

Dec 21, 2021Actual

Completion Date

Dec 21, 2021Actual

First Submitted Date

Sep 28, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2026

Last Update Posted Date

Mar 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fatigue Severity Scale scores assessment	Experimental	Fatigue Severity Scale scores assessment	Other: Follow up and Assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow up and Assessment	Other	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...)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe ROBERT, PU-PH	CHU de NICE, Centre Mémoire Ressources et Recherches	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Memoire Ressources et Recherche, CHU de Nice		Nice		06000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35608793	Result	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.

ID	Term
D053609	Lethargy
D005221	Fatigue

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

ID	Term
D032763	Behavior Control
D013812	Therapeutics
D007103	Immobilization
D008919	Investigative Techniques