Clinical trial Recruiting at 1 site Observational Ages 70 to 85

Identifying markers of apathy in elderly patients with bipolar disorder

Official title: Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept

Run by Hospital Center Guillaume Régnier · NCT06914284 · Data updated 2026-11-12

This study is trying to find signs of apathy in older adults with bipolar disorder to see if they are at risk for memory problems and dementia.

More Bipolar Disorder trials

Quick facts

Study typeObservational
Ages70 Years to 85 Years
SexAll
Enrollment30 (estimated)
SponsorHospital Center Guillaume Régnier
Academic / other
Locations1 site (Rennes, Ile Et Vilaine)
StatusRecruiting
StartedJuly 1, 2024
Main results expectedJanuary 2026
Study endsJanuary 2029
Registry record updatedApril 6, 2025
Trial IDNCT06914284 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are elderly individuals aged 70 to 85 with a diagnosis of bipolar disorder who are living at home and meet specific cognitive and physical criteria.

Probably not a fit

Patients with unipolar depression, significant cognitive disorders, or other psychiatric and neurological co-morbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify reliable neurobehavioral markers of apathy in elderly individuals aged 70 to 85 with bipolar disorder. By measuring motor activity through actimetry, analyzing speech patterns using artificial intelligence, and conducting MRI scans, researchers will compare participants with bipolar disorder to healthy volunteers. The goal is to pinpoint individuals at high risk of cognitive decline and dementia. Participants will undergo cognitive testing to assess their verbal memory and fluency.

Why it matters

Potential benefit: If successful, this study could lead to early identification of elderly patients at risk for dementia, allowing for timely interventions.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in identifying cognitive decline markers in other populations, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Population: Age between 70 and 85 years-old, living at home (Participants living in nursing homes are not included).
2. Condition: OABD type 1, type 2 and type 3 assessed by the DSM5 criteria
3. Stable: no MDE or hypomanic state within the last 6 months
4. Ambulatory setting only
5. General condition: Successful Gait speed test from the Short Physical Performance Battery (SPPB): beingable to walk 4 meters in 4 seconds (SPPB NIH Toolbox)44
6. Person affiliated to a social security regime
7. Patients who have given their free, informed and written consent to take part in the study

Exclusion Criteria:

1. Psychiatric conditions and or co-morbidities

   1. Unipolar depression
   2. Recurrent unipolar depression
   3. Substance use disorder according to DSM5 criteria. Benzodiaepine and/or z-drugs dependence are accepted.
2. Neurological and cerebral co-morbidities

   1. Major Cognitive Disorder: significant cognitive decline characterized by extensive cognitive tests or at least a standardized clinical evaluation AND at least loss of autonomy in complex instrumental daily living function, not related to delirium (DSM5 criteria)
   2. Medical history of known degenerative disorders: Alzheimer's disease, Lobar Degenerative Fronto-temporal disorders, Lewy Body disease, corticobasal degenerative disorder, Supranuclear Palsy, epilepsy.
   3. Medical history of known Parkinson's disease (according to the Movement Disorder Society (MDS)45 criteria)
   4. Medical history of known stroke
   5. Severe Parkinsonism (defined by MDS-Unified Parkinson's Disease Rating Scale46 \> 20)
3. MRI contra-indications: metallic implants, severe claustrophobia
4. Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
5. Hospitalized at inclusion

Where it's running

  • Centre Hospitalier Guillaume Regnier
    Rennes, Ile Et Vilaine, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.