Study of Degenerescence CSF Hallmarks in Older Bipolar Patients (BPL-1318)

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ClinicalTrials.gov Identifier: NCT02836054

Recruitment Status : Unknown

Verified January 2019 by University Hospital, Grenoble.
Recruitment status was: Recruiting

First Posted : July 18, 2016

Last Update Posted : January 7, 2019

Sponsor:

Information provided by (Responsible Party):

University Hospital, Grenoble

Study Description

Brief Summary:

Analysis of 4 CSF Alzheimer's disease biomarkers (total and phosphorylated tau protein, Aß40 and Aß1-42) and morphological brain MRI in older patients (>60 year's old) with bipolar disorder, after an evaluation of their cognitive functions.

Comparison between two groups of patients : patients with cognitive disorders and patients without cognitive disorders.

The objective is to describe and compare the profile of those biomarkers in those two populations.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder Alzheimer's Disease	Procedure: lumbar puncture (LP) Procedure: brain MRI	Not Applicable

Detailed Description:

Describe the profile of the 4 neurodegeneration's biomarkers of Alzheimer's disease dosed in the cerebrospinal fluid (Total Tau proteins, phosphorylated, Aß40 and Aß1-42) for old subjects suffering from bipolar disorder with or without cognitive impairment.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
Study Start Date :	November 2013
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bipolar disorder Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Bipolar Disorder

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Patients with cognitive disorders lumbar punction + brain MRI	Procedure: lumbar puncture (LP) Procedure: brain MRI
Patients without cognitive disorders lumbar punction + brain MRI	Procedure: lumbar puncture (LP) Procedure: brain MRI

Outcome Measures

Primary Outcome Measures :

Profile 4 neurodegeneration's biomarkers of Alzheimer's disease dosed in cerebrospinal fluid of aged subjects with bipolar disorder : Total Tau proteins, phosphorylated Tau proteins, Aß40 and Aß1-42 concentration [ Time Frame: 3 hours 50 minutes (total of the 4 primary outcome measures described) ]
The mean concentration of each biomarker is measured independently. The analysis between the 2 groups is done with the profile of the 4 biomarkers, not only between the profile of one biomarker to another.

Eligibility Criteria

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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 between 60 and 80
french-speaking, reading and writing patient
affiliation to the French Social Security
written informed consent obtained from the patient
agree to undergo a lumbar puncture
easy accessibility for the lumbar puncture
Mini Mental State Examination (MMSE) > 20
bipolar patients :
- type I or II
- state of euthymia for at least 4 weeks
- stable psychotropic drug treatment for at least 8 weeks
- no electroconvulsive therapy during the 6 months before inclusion
distribution in the "with cognitive disorder" or "without cognitive disorder" group is function of the result of the neuropsychological evaluation

Non-inclusion Criteria :

severe visual or auditory disorder
advanced lumbar osteoarthritis
history of severe head injury, neurological disorders, diagnosed dementia
addiction weaned for less than 12 months
forced hospitalization in psychiatry
MRI contraindications
LP contraindications

Exclusion Criteria:

- at least one of the outcome measures can't be performed :

MRI
LP : anticoagulation, bad accessibility

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): NCT02836054

Contacts

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Contact: Lora COHEN	0476765790/0476769284	LCohen@chu-grenoble.fr

Locations

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France
University Hospital, Grenoble	Recruiting
Grenoble, Isère, France, 38043
Principal Investigator: Lora COHEN
Sub-Investigator: Thierry BOUGEROL
Sub-Investigator: Olivier Moreaud

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

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Principal Investigator:	Lora COHEN	CMRR, Pavillon de Neurologie, C.H.U. de 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.

Augy Jennifer, Enjeux cliniques et évolutifs des troubles bipolaires. A partir d'une étude sur l'évaluation cognitive de patients bipolaires vieillissants. Thèse d'exercice. 2010.

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.

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.

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.

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.

Menecier P, Rouaud O, Arezes C, Nasr D, Menecier-Ossia L, Charvet-Blanc A, Ploton L. [Bipolar disorders and dementia: fortuitous association or filiation? A case-report and review of the literature]. Psychol Neuropsychiatr Vieil. 2007 Mar;5(1):23-34. Review. French.

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.

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.

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.

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.

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:	NCT02836054
Other Study ID Numbers:	38RC13.408 2013-A00930-45 ( Other Identifier: ID RCB )
First Posted:	July 18, 2016 Key Record Dates
Last Update Posted:	January 7, 2019
Last Verified:	January 2019

Keywords provided by University Hospital, Grenoble:


biomarkers CSF MRI	Alzheimer's disease bipolar disorder cognitive functions

Additional relevant MeSH terms:

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Alzheimer Disease Bipolar Disorder Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Bipolar and Related Disorders

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