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

ConditionsApathyBipolar Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70-85
SponsorHospital Center Guillaume Régnier

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Actigraphy and MRI

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Old Age Bipolar Disorder1 intervention
Group B: Healthy Controls1 intervention

Trial outcomes

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

Time frame
during 4 days

Secondary outcomes

1

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

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.

Time frame
baseline and only for OABD participants at 12 month and 36 month
2

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

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

Time frame
at Day 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Center Guillaume Régnier

Lead sponsor

Rennes University Hospital

Collaborator

Fondation de l'Avenir

Collaborator

Source ClinicalTrials.gov
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