Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection? (BIPAGE)

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ClinicalTrials.gov Identifier: NCT02843906

Recruitment Status : Unknown

Verified July 2016 by University Hospital, Grenoble.
Recruitment status was: Recruiting

First Posted : July 26, 2016

Last Update Posted : July 26, 2016

Sponsor:

Collaborators:

University Hospital, Tours

Assistance Publique - Hôpitaux de Paris

University Hospital, Marseille

Hospices Civils de Lyon

Centre Hospitalier Universitaire de Besancon

Central Hospital, Nancy, France

University Hospital, Clermont-Ferrand

Versailles Hospital

University Hospital, Montpellier

Reims University Hospital

Centre Hospitalier Princesse Grace

Information provided by (Responsible Party):

University Hospital, Grenoble

Study Description

Brief Summary:

The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of cognitive deficits in older patients with bipolar disorders.

Condition or disease	Intervention/treatment	Phase
Senile Plaques Tau Proteins Alzheimer Disease Bipolar Disorders Mild Cognitive Impairment	Procedure: Lombar Punction Radiation: Magnetic Resonance Imaging (MRI) Radiation: Positron-Emission Tomography (TEP) /(FDG) Other: Psychiatric tests Other: Neuropsychological Tests Genetic: Apolipoprotein (ApoE) detection	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	180 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?
Study Start Date :	July 2015
Estimated Primary Completion Date :	July 2018
Estimated Study Completion Date :	July 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bipolar disorder Alzheimer disease

MedlinePlus related topics: Bipolar Disorder

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: BD/CD + Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests	Procedure: Lombar Punction cerebrospinal fluid testing at screening and M36 Radiation: Magnetic Resonance Imaging (MRI) MRI done at screening and M36 Radiation: Positron-Emission Tomography (TEP) /(FDG) TEP/FDG done at screening and M36 Other: Psychiatric tests Other: Neuropsychological Tests done at screening, M12, M24 and M36 Genetic: Apolipoprotein (ApoE) detection ApoE detection done at screening
Active Comparator: BD/CD - Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests	Procedure: Lombar Punction cerebrospinal fluid testing at screening and M36 Radiation: Magnetic Resonance Imaging (MRI) MRI done at screening and M36 Radiation: Positron-Emission Tomography (TEP) /(FDG) TEP/FDG done at screening and M36 Other: Psychiatric tests Other: Neuropsychological Tests done at screening, M12, M24 and M36 Genetic: Apolipoprotein (ApoE) detection ApoE detection done at screening
Active Comparator: a-MCI Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests	Procedure: Lombar Punction cerebrospinal fluid testing at screening and M36 Radiation: Magnetic Resonance Imaging (MRI) MRI done at screening and M36 Radiation: Positron-Emission Tomography (TEP) /(FDG) TEP/FDG done at screening and M36 Other: Psychiatric tests Other: Neuropsychological Tests done at screening, M12, M24 and M36 Genetic: Apolipoprotein (ApoE) detection ApoE detection done at screening

Outcome Measures

Primary Outcome Measures :

Functionnal/Cognitive evaluation [ Time Frame: Half an hour ]
Global cognitive evaluation :

MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL.
Psychatric evaluation [ Time Frame: 15 minutes ]
Semi-directive psychiatric interview.
Psychatric evaluation [ Time Frame: 15 minutes ]
Scales for thymus evaluation : GDS, YMRS, BPRS, STAI
Brain MRI [ Time Frame: 40 minutes ]
Enable neuropsychological evaluation.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	60 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female subject aged between 60 and 80 years old
in patient or out-patient at one of the centers participating in the study
Mini-mental state examination (MMSE) score > 20 at baseline
patient with diagnostic of amnestic-Mild Cognitive Impairment
patients suffering of bipolar disorders type I or II
in remitted (euthymic) state at baseline

Exclusion Criteria:

pre-existing history of dementia
history of neurologic disorder
lifetime history of a severe psychiatric disorder other than bipolar disorders
current medical problems
patients treated with electroconvulsive therapy within the past six months
patients with substance abuse or dependence within the past 12 months
patients hospitalized without consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843906

Contacts

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Contact: COHEN CL Lora, Doctor	33476766089	lcohen@chu-grenoble.fr

Locations

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France
University Hospital, Tours	Recruiting
Tours, France, 37000
Contact: Camus CV Vincent, Professor

Sponsors and Collaborators

University Hospital, Grenoble

University Hospital, Tours

Assistance Publique - Hôpitaux de Paris

University Hospital, Marseille

Hospices Civils de Lyon

Centre Hospitalier Universitaire de Besancon

Central Hospital, Nancy, France

University Hospital, Clermont-Ferrand

Versailles Hospital

University Hospital, Montpellier

Reims University Hospital

Centre Hospitalier Princesse Grace

Investigators

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Principal Investigator:	BOUGEROL BT Thierry, Professor	University Hospital, Grenoble

More Information

Publications:

Ali SO, Denicoff KD, Altshuler LL, Hauser P, Li X, Conrad AJ, Smith-Jackson EE, Leverich GS, Post RM. Relationship between prior course of illness and neuroanatomic structures in bipolar disorder: a preliminary study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Oct-Dec;14(4):227-32.

Amieva H, Le Goff M, Millet X, Orgogozo JM, Pérès K, Barberger-Gateau P, Jacqmin-Gadda H, Dartigues JF. Prodromal Alzheimer's disease: successive emergence of the clinical symptoms. Ann Neurol. 2008 Nov;64(5):492-8. doi: 10.1002/ana.21509.

Bora E, Vahip S, Gonul AS, Akdeniz F, Alkan M, Ogut M, Eryavuz A. Evidence for theory of mind deficits in euthymic patients with bipolar disorder. Acta Psychiatr Scand. 2005 Aug;112(2):110-6.

Chételat G, Eustache F, Viader F, De La Sayette V, Pélerin A, Mézenge F, Hannequin D, Dupuy B, Baron JC, Desgranges B. FDG-PET measurement is more accurate than neuropsychological assessments to predict global cognitive deterioration in patients with mild cognitive impairment. Neurocase. 2005 Feb;11(1):14-25.

Chételat G, Desgranges B, Eustache F. [Brain profile of hypometabolism in early Alzheimer's disease: relationships with cognitive deficits and atrophy]. Rev Neurol (Paris). 2006 Oct;162(10):945-51. Review. French.

Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer's disease in late onset families. Science. 1993 Aug 13;261(5123):921-3.

Delaloye C, Moy G, Baudois S, de Bilbao F, Remund CD, Hofer F, Ragno Paquier C, Campos L, Weber K, Gold G, Moussa A, Meiler CC, Giannakopoulos P. Cognitive features in euthymic bipolar patients in old age. Bipolar Disord. 2009 Nov;11(7):735-43. doi: 10.1111/j.1399-5618.2009.00741.x. Epub 2009 Aug 28.

Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lövblad KO, Gold G, Giannakopoulos P. Longitudinal analysis of cognitive performances and structural brain changes in late-life bipolar disorder. Int J Geriatr Psychiatry. 2011 Dec;26(12):1309-18. doi: 10.1002/gps.2683. Epub 2011 Mar 10.

Doring TM, Kubo TT, Cruz LC Jr, Juruena MF, Fainberg J, Domingues RC, Gasparetto EL. Evaluation of hippocampal volume based on MR imaging in patients with bipolar affective disorder applying manual and automatic segmentation techniques. J Magn Reson Imaging. 2011 Mar;33(3):565-72. doi: 10.1002/jmri.22473.

Ewers M, Buerger K, Teipel SJ, Scheltens P, Schröder J, Zinkowski RP, Bouwman FH, Schönknecht P, Schoonenboom NS, Andreasen N, Wallin A, DeBernardis JF, Kerkman DJ, Heindl B, Blennow K, Hampel H. Multicenter assessment of CSF-phosphorylated tau for the prediction of conversion of MCI. Neurology. 2007 Dec 11;69(24):2205-12.

Fagan AM, Mintun MA, Shah AR, Aldea P, Roe CM, Mach RH, Marcus D, Morris JC, Holtzman DM. Cerebrospinal fluid tau and ptau(181) increase with cortical amyloid deposition in cognitively normal individuals: implications for future clinical trials of Alzheimer's disease. EMBO Mol Med. 2009 Nov;1(8-9):371-80. doi: 10.1002/emmm.200900048.

Hindley NJ, Jobst KA, King E, Barnetson L, Smith A, Haigh AM. High acceptability and low morbidity of diagnostic lumbar puncture in elderly subjects of mixed cognitive status. Acta Neurol Scand. 1995 May;91(5):405-11.

Jones LD, Payne ME, Messer DF, Beyer JL, MacFall JR, Krishnan KR, Taylor WD. Temporal lobe volume in bipolar disorder: relationship with diagnosis and antipsychotic medication use. J Affect Disord. 2009 Apr;114(1-3):50-7. doi: 10.1016/j.jad.2008.07.003. Epub 2008 Aug 8.

Kessing LV, Nilsson FM. Increased risk of developing dementia in patients with major affective disorders compared to patients with other medical illnesses. J Affect Disord. 2003 Feb;73(3):261-9.

Kessing LV, Andersen PK. Does the risk of developing dementia increase with the number of episodes in patients with depressive disorder and in patients with bipolar disorder? J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1662-6.

Li G, Sokal I, Quinn JF, Leverenz JB, Brodey M, Schellenberg GD, Kaye JA, Raskind MA, Zhang J, Peskind ER, Montine TJ. CSF tau/Abeta42 ratio for increased risk of mild cognitive impairment: a follow-up study. Neurology. 2007 Aug 14;69(7):631-9.

Masouy A, Chopard G, Vandel P, Magnin E, Rumbach L, Sechter D, Haffen E. Bipolar disorder and dementia: where is the link? Psychogeriatrics. 2011 Mar;11(1):60-7. doi: 10.1111/j.1479-8301.2010.00348.x.

Martino DJ, Igoa A, Marengo E, Scápola M, Ais ED, Strejilevich SA. Cognitive and motor features in elderly people with bipolar disorder. J Affect Disord. 2008 Jan;105(1-3):291-5. Epub 2007 Jun 18.

Meeks S. Bipolar disorder in the latter half of life: symptom presentation, global functioning and age of onset. J Affect Disord. 1999 Jan-Mar;52(1-3):161-7.

Peskind E, Nordberg A, Darreh-Shori T, Soininen H. Safety of lumbar puncture procedures in patients with Alzheimer's disease. Curr Alzheimer Res. 2009 Jun;6(3):290-2.

Peskind ER, Riekse R, Quinn JF, Kaye J, Clark CM, Farlow MR, Decarli C, Chabal C, Vavrek D, Raskind MA, Galasko D. Safety and acceptability of the research lumbar puncture. Alzheimer Dis Assoc Disord. 2005 Oct-Dec;19(4):220-5.

Preuss UW, Watzke S, Choi JH. Diagnostic correlates of Alzheimer dementia in a U.S. Nationwide inpatient sample. Am J Geriatr Psychiatry. 2010 Sep;18(9):821-9. doi: 10.1097/JGP.0b013e3181ca3a13.

Saunders AM, Strittmatter WJ, Schmechel D, George-Hyslop PH, Pericak-Vance MA, Joo SH, Rosi BL, Gusella JF, Crapper-MacLachlan DR, Alberts MJ, et al. Association of apolipoprotein E allele epsilon 4 with late-onset familial and sporadic Alzheimer's disease. Neurology. 1993 Aug;43(8):1467-72.

Tapiola T, Alafuzoff I, Herukka SK, Parkkinen L, Hartikainen P, Soininen H, Pirttilä T. Cerebrospinal fluid {beta}-amyloid 42 and tau proteins as biomarkers of Alzheimer-type pathologic changes in the brain. Arch Neurol. 2009 Mar;66(3):382-9. doi: 10.1001/archneurol.2008.596.

Thomann PA, Kaiser E, Schönknecht P, Pantel J, Essig M, Schröder J. Association of total tau and phosphorylated tau 181 protein levels in cerebrospinal fluid with cerebral atrophy in mild cognitive impairment and Alzheimer disease. J Psychiatry Neurosci. 2009 Mar;34(2):136-42.

Vemuri P, Wiste HJ, Weigand SD, Knopman DS, Trojanowski JQ, Shaw LM, Bernstein MA, Aisen PS, Weiner M, Petersen RC, Jack CR Jr; Alzheimer's Disease Neuroimaging Initiative. Serial MRI and CSF biomarkers in normal aging, MCI, and AD. Neurology. 2010 Jul 13;75(2):143-51. doi: 10.1212/WNL.0b013e3181e7ca82.

Verghese PB, Castellano JM, Holtzman DM. Apolipoprotein E in Alzheimer's disease and other neurological disorders. Lancet Neurol. 2011 Mar;10(3):241-52. doi: 10.1016/S1474-4422(10)70325-2. Review.

Wingo AP, Harvey PD, Baldessarini RJ. Neurocognitive impairment in bipolar disorder patients: functional implications. Bipolar Disord. 2009 Mar;11(2):113-25. doi: 10.1111/j.1399-5618.2009.00665.x. Review.

Zetterberg H, Tullhög K, Hansson O, Minthon L, Londos E, Blennow K. Low incidence of post-lumbar puncture headache in 1,089 consecutive memory clinic patients. Eur Neurol. 2010;63(6):326-30. doi: 10.1159/000311703. Epub 2010 Jun 3.

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Responsible Party:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT02843906
Other Study ID Numbers:	38RC13.217
First Posted:	July 26, 2016 Key Record Dates
Last Update Posted:	July 26, 2016
Last Verified:	July 2016

Keywords provided by University Hospital, Grenoble:


alzheimer disease bipolar disorders mild cognitive impairement

Additional relevant MeSH terms:

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Alzheimer Disease Disease Plaque, Amyloid Cognitive Dysfunction Bipolar Disorder Pathologic Processes Dementia Brain Diseases Central Nervous System Diseases	Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders Bipolar and Related Disorders Pathological Conditions, Anatomical

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