Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept
Launched by HOSPITAL CENTER GUILLAUME RÉGNIER · Apr 3, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how to identify signs of apathy in older adults with bipolar disorder, aged 70 to 85 years. Apathy is when someone feels a lack of interest or motivation, which can be an early warning sign of dementia. The researchers want to find dependable ways to spot these signs by measuring physical activity, analyzing speech, and looking at brain changes through MRI scans. They will compare older adults with bipolar disorder to healthy volunteers in the same age group to see how these markers differ.
To participate, individuals must be between 70 and 85 years old, live at home, and have stable bipolar disorder without recent severe mood episodes. Participants will wear a small device on their wrist for four days to track movements, undergo an MRI scan, and complete three simple cognitive tests that involve memory and storytelling. This study aims to help in understanding how apathy relates to cognitive decline and could lead to better care for older adults facing these challenges.
Gender
ALL
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
About Hospital Center Guillaume Régnier
Hospital Center Guillaume Régnier is a leading healthcare institution dedicated to advancing medical research and clinical excellence. Located in Rennes, France, the center specializes in psychiatric and mental health services, providing comprehensive care and innovative treatment options. As a clinical trial sponsor, it is committed to fostering scientific inquiry through rigorous research protocols and collaboration with multidisciplinary teams. The center prioritizes patient safety and ethical standards while contributing to the development of new therapies and interventions that enhance patient outcomes in mental health care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rennes, Ile Et Vilaine, France
Patients applied
Trial Officials
Gabriel RG ROBERT
Principal Investigator
HC Guillaume Regnier
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported