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

Alzheimer Disease Clinical Trial

— BIPAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02843906
• Other study ID #: 38RC13.217
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2016
• Last updated: July 22, 2016
• Start date: July 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2016
• Source: University Hospital, Grenoble
• Contact: COHEN CL Lora, Doctor
• Phone: 33476766089
• Email: lcohen[@]chu-grenoble.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Alzheimer Disease
• Bipolar Disorder
• Bipolar Disorders
• Cognition Disorders
• Disease
• Mild Cognitive Impairment
• Plaque, Amyloid
• Senile Plaques
• Tau Proteins

Intervention

Procedure:
• Lombar Punction
cerebrospinal fluid testing at screening and M36

Radiation:
• Magnetic Resonance Imaging (MRI)
MRI done at screening and M36
• Positron-Emission Tomography (TEP) /(FDG)
TEP/FDG done at screening and M36

Other:
• Psychiatric tests

• Neuropsychological Tests
done at screening, M12, M24 and M36

Genetic:
• Apolipoprotein (ApoE) detection
ApoE detection done at screening

Locations

Country	Name	City	State
France	University Hospital, Tours	Tours

Sponsors (12)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Assistance Publique - Hôpitaux de Paris, Central Hospital, Nancy, France, Central Hospital, Versailles, Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Besancon, Hospices Civils de Lyon, University Hospital, Clermont-Ferrand, University Hospital, Marseille, University Hospital, Montpellier, University Hospital, Reims, University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (29)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functionnal/Cognitive evaluation	Global cognitive evaluation : MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL.	Half an hour	No
Primary	Psychatric evaluation	Semi-directive psychiatric interview.	15 minutes	No
Primary	Psychatric evaluation	Scales for thymus evaluation : GDS, YMRS, BPRS, STAI	15 minutes	No
Primary	Brain MRI	Enable neuropsychological evaluation.	40 minutes	No