Markers of apathy and memory decline in older adults with bipolar disorder
Tests movement tracking, speech and brain scans for apathy in older bipolar patients.
Key facts
- Who runs it
- Hospital Center Guillaume Régnier
- Where
- Rennes, FranceSee the site
- Trial code
- Registry title
- Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 1 Jul 2024
- Expected to end
- Jan 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Actigraphy and MRI
- Record updated
- 6 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 70 to 85 with bipolar disorder who live at home, and for healthy volunteers of the same age, to study markers of apathy.
- Age
- 70 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Bipolar disorder type 1, 2 or 3 (DSM5 criteria), stable: no major depressive episode or hypomanic state in the last 6 months. Outpatients only.
Main reasons for not taking part
- Living in a nursing home or hospitalized at inclusion
- Unipolar depression, or substance use disorder (benzodiazepine or z-drug dependence is accepted)
- Major cognitive disorder, or known degenerative disease, Parkinson's disease, epilepsy or stroke
- MRI not possible (metallic implants, severe claustrophobia)
- Under legal protection or deprived of liberty
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Population: Age between 70 and 85 years-old, living at home (Participants living in nursing homes are not included)
- Condition: OABD type 1, type 2 and type 3 assessed by the DSM5 criteria
- Stable: no MDE or hypomanic state within the last 6 months
- Ambulatory setting only
- 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
- Person affiliated to a social security regime
- Patients who have given their free, informed and written consent to take part in the study
Who cannot take part
- MRI contra-indications: metallic implants, severe claustrophobia
- Psychiatric conditions and or co-morbidities; Unipolar depression; Recurrent unipolar depression; Substance use disorder according to DSM5 criteria. Benzodiaepine and/or z-drugs dependence are accepted
- Neurological and cerebral co-morbidities; 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); Medical history of known degenerative disorders: Alzheimer's disease, Lobar Degenerative Fronto-temporal disorders, Lewy Body disease, corticobasal degenerative disorder, Supranuclear Palsy, epilepsy; Medical history of known Parkinson's disease (according to the Movement Disorder Society (MDS)45 criteria); Medical history of known stroke; Severe Parkinsonism (defined by MDS-Unified Parkinson's Disease Rating Scale46 > 20)
- Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty
- Hospitalized at inclusion
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 70 and 85 years old?
Where in France
- Centre hospitalier Guillaume RégnierRennes, FranceContact: Gabriel RG ROBERT, MDTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 2 groups in the trial
- Old Age Bipolar Disorder
the strategy procedure will consist of using actigraphy and MRI. The wGT3X-BT actigraph (wGT3x-BT) will be worn on the wrist for 5 days. The set up is made at Day 1. The actigraph will be programmed to automatically switch off after 4 full days of use (96 hours). After 5 full days (120 hours), the participant returns to the research center so the data are downloaded on a secured computer dedicated to store and analyse the data. At day 5, a MRI will be perform.The total acquisition time is about 45 minutes: * Degenerative: anatomical 3DT1 (\~5 minutes acquisition). * Inflammation: multicompartment imaging models (\~15 minutes acquisition) such as the Neurite Orientation and Dispersion Index (NODDI) are used to quantify in-vivo microstructure inflammation. * Vascular: 3D Fluid-attenuated inversion recovery (FLAIR \~5 minutes acquisition) and Arterial Spin labelling (ASL, \~8 minutes acquisition) * Functional connectivity: rs BOLD (\~10 minutes acquisition)
Treatment: Actigraphy and MRI
- Healthy Controls
the strategy procedure will consist of using actigraphy and MRI. The wGT3X-BT actigraph (wGT3x-BT) will be worn on the wrist for 5 days. The set up is made at Day 1. The actigraph will be programmed to automatically switch off after 4 full days of use (96 hours). After 5 full days (120 hours), the participant returns to the research center so the data are downloaded on a secured computer dedicated to store and analyse the data. At day 5, a MRI will be perform.The total acquisition time is about 45 minutes: * Degenerative: anatomical 3DT1 (\~5 minutes acquisition). * Inflammation: multicompartment imaging models (\~15 minutes acquisition) such as the Neurite Orientation and Dispersion Index (NODDI) are used to quantify in-vivo microstructure inflammation. * Vascular: 3D Fluid-attenuated inversion recovery (FLAIR \~5 minutes acquisition) and Arterial Spin labelling (ASL, \~8 minutes acquisition) * Functional connectivity: rs BOLD (\~10 minutes acquisition)
Treatment: Actigraphy and MRI
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept
- Plain-language title
- Markers of apathy and memory decline in older adults with bipolar disorderGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06914284, who can take part
- Record updated
- 6 April 2025