BPL-1318: Study of Degenerescence CSF Hallmarks in Older Bipolar Patients
Study Details
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Patients with cognitive disorders lumbar punction + brain MRI |
Procedure: lumbar puncture (LP)
Procedure: brain MRI
|
| Other: 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 [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
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
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bipolar patients :
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type I or II
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state of euthymia for at least 4 weeks
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stable psychotropic drug treatment for at least 8 weeks
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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 :
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severe visual or auditory disorder
-
advanced lumbar osteoarthritis
-
history of severe head injury, neurological disorders, diagnosed dementia
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital, Grenoble | Grenoble | Isère | France | 38043 |
Sponsors and Collaborators
- University Hospital, Grenoble
Investigators
- Principal Investigator: Lora COHEN, CMRR, Pavillon de Neurologie, C.H.U. de Grenoble
Study Documents (Full-Text)
None provided.More Information
Publications
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- 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.
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- 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.
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- 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.
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- 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.
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- 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 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.
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- 38RC13.408
- 2013-A00930-45