Identifying markers of apathy in elderly patients with bipolar disorder
Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 70 Years to 85 Years |
| Sex | All |
| Sponsor | Hospital Center Guillaume Régnier Academic / other |
| Locations | 1 site (Rennes, Ile Et Vilaine) |
| Trial ID | NCT06914284 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unipolar depression, significant cognitive disorders, or other psychiatric and neurological co-morbidities may not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown promise in identifying cognitive decline markers in other populations, suggesting potential for success.
Eligibility criteria
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 this trial is running
Rennes, Ile Et Vilaine
- Centre Hospitalier Guillaume Regnier — Rennes, Ile Et Vilaine, France (Recruiting)
Study contacts
- Principal investigator: Gabriel RG ROBERT — HC Guillaume Regnier
- Study coordinator: Gabriel RG ROBERT
- Email: g.robert@ch-guillaumeregnier.fr
- Phone: 0299333937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.