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

April 3, 2025 updated by: Hospital Center Guillaume Régnier

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Ile Et Vilaine
      • Rennes, Ile Et Vilaine, France, 35000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Actigraphic measures acquired by OABD participants and with those of Healthy controls (HC)
Time Frame: during 4 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech biomarkers :Temporal, Source, Prosodic and Spectral speech features automatically derived from the audio recordings of 3 cognitive tasks.
Time Frame: baseline and only for OABD participants at 12 month and 36 month
To identify a set of speech biomarkers, specific to OABD (compared to HC), 3 cognitive tasks , verbal learning (with the Rey Auditory Verbal Learning Task), semantic verbal fluency task and narrative storytelling are implemented on the Milli® platform. Each of these tasks enable to derive temporal, source, prosodic and spectral features from remote recordings.
baseline and only for OABD participants at 12 month and 36 month
MRI derived cerebral features, specific to OABD participants compared to Healthy control
Time Frame: at Day 4
measure cortical thickness and sub-cortical volumes to identify degenerative alterations measure water diffusion in several cellular compartments and appropriate multi compartment modeling (MCM) such as Neurite Orientation Diffusion and Dispersion Index (NODDI) to identify Inflammation Measure tissue blood flow Using arterial spin labeling (ASL) to identify Vascular health
at Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Center Guillaume Régnier

Collaborators

Rennes University Hospital
Fondation de l'Avenir

Investigators

  • Principal Investigator: Gabriel RG ROBERT, HC Guillaume Regnier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC24_01_GR/ANACONDA
  • ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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