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Recruiting NCT06914284

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

— Observational Apathy Bipolar Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Actigraphy and MRI.
Who it may be relevant to
Registry conditions: Apathy, Bipolar Disorder. Basic parameters: 70 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Compare Actigraphic measures acquired by OABD participants and with those of Healthy controls (HC) [Time frame: during 4 days]
Secondary outcome measures (2)
  • 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]
  • MRI derived cerebral features, specific to OABD participants compared to Healthy control [Time frame: at Day 4]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Hospitalized at inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Centre Hospitalier Guillaume Regnier — Rennes

Publications

  • Wu YT, Beiser AS, Breteler MMB, Fratiglioni L, Helmer C, Hendrie HC, Honda H, Ikram MA, Langa KM, Lobo A, Matthews FE, Ohara T, Peres K, Qiu C, Seshadri S, Sjolund BM, Skoog I, Brayne C. The changing prevalence and incidence of dementia over time - current evidence. Nat Rev Neurol. 2017 Jun;13(6):327-339. doi: 10.1038/nrneurol.2017.63. Epub 2017 May 12. PMID 28497805
  • Richmond-Rakerd LS, D'Souza S, Milne BJ, Caspi A, Moffitt TE. Longitudinal Associations of Mental Disorders With Dementia: 30-Year Analysis of 1.7 Million New Zealand Citizens. JAMA Psychiatry. 2022 Apr 1;79(4):333-340. doi: 10.1001/jamapsychiatry.2021.4377. PMID 35171209
  • Diniz BS, Butters MA, Albert SM, Dew MA, Reynolds CF 3rd. Late-life depression and risk of vascular dementia and Alzheimer's disease: systematic review and meta-analysis of community-based cohort studies. Br J Psychiatry. 2013 May;202(5):329-35. doi: 10.1192/bjp.bp.112.118307. PMID 23637108
  • Byers AL, Yaffe K. Depression and risk of developing dementia. Nat Rev Neurol. 2011 May 3;7(6):323-31. doi: 10.1038/nrneurol.2011.60. PMID 21537355
  • 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. PMID 32664001
  • Kaup AR, Byers AL, Falvey C, Simonsick EM, Satterfield S, Ayonayon HN, Smagula SF, Rubin SM, Yaffe K. Trajectories of Depressive Symptoms in Older Adults and Risk of Dementia. JAMA Psychiatry. 2016 May 1;73(5):525-31. doi: 10.1001/jamapsychiatry.2016.0004. PMID 26982217
  • Almeida OP, McCaul K, Hankey GJ, Yeap BB, Golledge J, Flicker L. Risk of dementia and death in community-dwelling older men with bipolar disorder. Br J Psychiatry. 2016 Aug;209(2):121-6. doi: 10.1192/bjp.bp.115.180059. Epub 2016 Jun 9. PMID 27482038
  • Velosa J, Delgado A, Finger E, Berk M, Kapczinski F, de Azevedo Cardoso T. Risk of dementia in bipolar disorder and the interplay of lithium: a systematic review and meta-analyses. Acta Psychiatr Scand. 2020 Jun;141(6):510-521. doi: 10.1111/acps.13153. Epub 2020 Feb 11. PMID 31954065

Identifiers

NCT: NCT06914284 · RC24_01_GR/ANACONDA · ID-RCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗