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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2024-A00407-40 |
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| Name | Class |
|---|---|
| Rennes University Hospital | OTHER |
| Fondation de l'Avenir | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Psychiatric conditions and or co-morbidities
Neurological and cerebral co-morbidities
MRI contra-indications: metallic implants, severe claustrophobia
Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
Hospitalized at inclusion
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel RG ROBERT | Contact | 0299333937 | +33 | g.robert@ch-guillaumeregnier.fr |
| Nathalie AN ALLETON | Contact | 0222514121 | +33 | n.alleton@ch-guillaumeregnier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel RG ROBERT | HC Guillaume Regnier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Guillaume Regnier | Recruiting | Rennes | Ile Et Vilaine | 35000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28497805 | Background | 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. | |
| 35171209 |
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| ID | Term |
|---|---|
| D053609 | Lethargy |
| D001714 | Bipolar Disorder |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D056044 | Actigraphy |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061725 | Accelerometry |
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|
| baseline and only for OABD participants at 12 month and 36 month |
| 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 | at Day 4 |
| 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. |
| 23637108 | Background | 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. |
| 21537355 | Background | 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. |
| 32664001 | Background | 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. |
| 26982217 | Background | 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. |
| 27482038 | Background | 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. |
| 31954065 | Background | 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. |
| 30015397 | Background | 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. |
| 36106698 | Background | 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. |
| 36509102 | Background | 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. |
| 15936426 | Background | Alexopoulos GS. Depression in the elderly. Lancet. 2005 Jun 4-10;365(9475):1961-70. doi: 10.1016/S0140-6736(05)66665-2. |
| 30027214 | Background | 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. |
| 30910421 | Background | 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. |
| 19908317 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D008919 |
| Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |