NCT06914284 Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept
| NCT ID | NCT06914284 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Center Guillaume Régnier |
| Condition | Apathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-07-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to identify reliable markers of apathy in elderly subjects with bipolar disorder, age between 70 and 85 years, in order to accurately identify subjects at high risk of progressing to dementia by measuring motor activity (actimetrics), recorded language and analysing brain changes (MRI). Actimetry is the measurement and recording of body movements using an actimeter. This device is worn on the wrist and contains sensors capable of measuring and recording all movements, including those of very low intensity. An automated speech analysis using artificial intelligence is used to detect low-intensity anomalies, and we want to test whether individual differences correspond to individual differences in brain anatomy and function. Researchers will compare elderly subjects with bipolar disorder and healthy volunteer, age between 70 and 85 years. Participants will be asked to: * Perform an MRI * Complete 3 cognitive tests: verbal memory, verbal fluency and an emotional storytelling task, in which you will be asked to describe a memory orally using positive, negative and neutral emotions. * wear an actimeter on your wrist for 4 days.
Eligibility 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
Contact & Investigator
Gabriel RG ROBERT
PRINCIPAL INVESTIGATOR
HC Guillaume Regnier
Frequently Asked Questions
Who can join the NCT06914284 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, up to 85 Years, studying Apathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06914284 currently recruiting?
Yes, NCT06914284 is actively recruiting participants. Contact the research team at g.robert@ch-guillaumeregnier.fr for enrollment information.
Where is the NCT06914284 trial being conducted?
This trial is being conducted at Rennes, France.
Who is sponsoring the NCT06914284 clinical trial?
NCT06914284 is sponsored by Hospital Center Guillaume Régnier. The principal investigator is Gabriel RG ROBERT at HC Guillaume Regnier. The trial plans to enroll 30 participants.