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

NCT06914284 | Recruiting

• 2 other identifiers: RC24_01_GR/ANACONDAID-RCB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Apathy; Bipolar Disorder

Keywords

Apathy; Actimetry; Neurobehavioral marker; Cognitive decline; Old Age Bipolar Disorder; MRI; Speech marker

Outcome Measures

Primary Outcomes (1)

• Compare Actigraphic measures acquired by OABD participants and with those of Healthy controls (HC)

  These very complex and highly dimensional signals are reduced to a sum, for a given period of time, of the variations in acceleration (in g/sec) after pre-processing (band-pass filtering) for each participants (OABD and healthy controls

  during 4 days

Secondary Outcomes (2)

• speech biomarkers :Temporal, Source, Prosodic and Spectral speech features automatically derived from the audio recordings of 3 cognitive tasks.

  baseline and only for OABD participants at 12 month and 36 month

• MRI derived cerebral features, specific to OABD participants compared to Healthy control

  at Day 4

Study Arms (2)

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)

Other: 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)

Other: Actigraphy and MRI

Interventions

Actigraphy and MRI OTHER

All participants will wear a wGT3X-BT actigraph (wGT3x-BT) for 4 days. Actigraphs are collected back at Day 4, after full 96 hours, when coming to the MRI platform. There, they will undergo 45 minutes MRI that acquire MRI signals to quantify degenerative, inflammatory, vascular and functional cerebral features.

Healthy Controls; Old Age Bipolar Disorder

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in the old-age psychiatry department of the Pôle Hospitalo-Universitaire de Psychiatrie Adulte (PHUPA) for OABD may be offered participation in the study. Eligible patients according to the inclusion criteria will be recruited during standard visits at CHGR. Informed consent along with a document describing the study will be presented during visit. Healthy volunteers will be recruited from the patient's relatives and/or via posters and/or the CHGR's internal networks.

You may qualify if:

• 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

You may not qualify if:

• 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)
• MRI contra-indications: metallic implants, severe claustrophobia
• Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.

Sponsors & Collaborators

• Hospital Center Guillaume Régnier: lead
• Rennes University Hospital: collaborator
• Fondation de l'Avenir: collaborator

Study Sites (1)

Centre Hospitalier Guillaume Regnier

Rennes, Ile Et Vilaine, 35000, France

RECRUITING

Related Publications (15)

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• Wu JJ, Wang HX, Yao W, Yan Z, Pei JJ. Late-life depression and the risk of dementia in 14 countries: a 10-year follow-up study from the Survey of Health, Ageing and Retirement in Europe. J Affect Disord. 2020 Sep 1;274:671-677. doi: 10.1016/j.jad.2020.05.059. Epub 2020 May 26.

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MeSH Terms

Conditions

Lethargy; Bipolar Disorder; Cognitive Dysfunction

Interventions

Actigraphy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Gabriel RG ROBERT

  HC Guillaume Regnier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel RG ROBERT

CONTACT

0299333937; g.robert@ch-guillaumeregnier.fr

Nathalie AN ALLETON

CONTACT

0222514121; n.alleton@ch-guillaumeregnier.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: April 6, 2025
• Study Start: July 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

FR (1)