Apathy-related Neurobehavioral Markers of Cognitive Decline in Old-age Bipolar Disorders: Proof-of-concept
NCT ID: NCT06914284
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-07-01
2029-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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)
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)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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. 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
70 Years
85 Years
ALL
Yes
Sponsors
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Rennes University Hospital
OTHER
Fondation de l'Avenir
OTHER
Hospital Center Guillaume Régnier
OTHER
Responsible Party
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Principal Investigators
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Gabriel RG ROBERT
Role: PRINCIPAL_INVESTIGATOR
HC Guillaume Regnier
Locations
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Centre Hospitalier Guillaume Regnier
Rennes, Ile Et Vilaine, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Almeida OP, Hankey GJ, Yeap BB, Golledge J, Flicker L. Older men with bipolar disorder: Clinical associations with early and late onset illness. Int J Geriatr Psychiatry. 2018 Dec;33(12):1613-1619. doi: 10.1002/gps.4957. Epub 2018 Jul 17.
John A, Saunders R, Desai R, Bell G, Fearn C, Buckman JEJ, Brown B, Nurock S, Michael S, Ware P, Marchant NL, Aguirre E, Rio M, Cooper C, Pilling S, Richards M, Stott J. Associations between psychological therapy outcomes for depression and incidence of dementia. Psychol Med. 2023 Aug;53(11):4869-4879. doi: 10.1017/S0033291722002537. Epub 2022 Sep 15.
Stott J, Saunders R, Desai R, Bell G, Fearn C, Buckman JEJ, Brown B, Nurock S, Michael S, Ware P, Marchant NL, Aguirre E, Rio M, Cooper C, Pilling S, Richards M, John A. Associations between psychological intervention for anxiety disorders and risk of dementia: a prospective cohort study using national health-care records data in England. Lancet Healthy Longev. 2023 Jan;4(1):e12-e22. doi: 10.1016/S2666-7568(22)00242-2. Epub 2022 Dec 9.
Alexopoulos GS. Depression in the elderly. Lancet. 2005 Jun 4-10;365(9475):1961-70. doi: 10.1016/S0140-6736(05)66665-2.
van Dalen JW, van Wanrooij LL, Moll van Charante EP, Brayne C, van Gool WA, Richard E. Association of Apathy With Risk of Incident Dementia: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2018 Oct 1;75(10):1012-1021. doi: 10.1001/jamapsychiatry.2018.1877.
Ruthirakuhan M, Herrmann N, Vieira D, Gallagher D, Lanctot KL. The Roles of Apathy and Depression in Predicting Alzheimer Disease: A Longitudinal Analysis in Older Adults With Mild Cognitive Impairment. Am J Geriatr Psychiatry. 2019 Aug;27(8):873-882. doi: 10.1016/j.jagp.2019.02.003. Epub 2019 Feb 7.
Dujardin K, Sockeel P, Delliaux M, Destee A, Defebvre L. Apathy may herald cognitive decline and dementia in Parkinson's disease. Mov Disord. 2009 Dec 15;24(16):2391-7. doi: 10.1002/mds.22843.
Other Identifiers
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ID-RCB
Identifier Type: OTHER
Identifier Source: secondary_id
RC24_01_GR/ANACONDA
Identifier Type: -
Identifier Source: org_study_id
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