Senile PlaquesBIPAGENCT02843906

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

A study testing Lombar Punction, Magnetic Resonance Imaging (MRI) and Positron-Emission Tomography (TEP) /(FDG) in people with Senile Plaques and Tau Proteins, run by University Hospital, Grenoble at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 60 to 80 years
Conditions the study is for: Senile Plaques, Tau Proteins, Alzheimer Disease
What is being tested?: Lombar Punction, Magnetic Resonance Imaging (MRI) and Positron-Emission Tomography (TEP) /(FDG)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteFrance
Study dates: Jul 2015to Jul 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

COHEN CL Lora, Doctor contact

33476766089

lcohen@chu-grenoble.fr

France1 site, 1 recruiting

University Hospital, Tours
Tours, 37000
Camus CV Vincent, Professor
Recruiting

Other trials in France

About this study

Conditions: Senile Plaques, Tau Proteins, Alzheimer Disease, Bipolar Disorders, Mild Cognitive Impairment
Being tested: Lombar Punction, Magnetic Resonance Imaging (MRI), Positron-Emission Tomography (TEP) /(FDG), Psychiatric tests, Neuropsychological Tests
Keywords: alzheimer disease, bipolar disorders, mild cognitive impairement
Medical subject headings: Plaque, Amyloid, Alzheimer Disease, Bipolar Disorder, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lombar PunctionProcedure or surgery
cerebrospinal fluid testing at screening and M36
Magnetic Resonance Imaging (MRI)Radiation
MRI done at screening and M36
Positron-Emission Tomography (TEP) /(FDG)Radiation
TEP/FDG done at screening and M36
Psychiatric testsOther
Neuropsychological TestsOther
done at screening, M12, M24 and M36
Apolipoprotein (ApoE) detectionGenetic
ApoE detection done at screening

Study groups in NCT02843906
Study group	Role	What they receive
BD/CD +	Active comparator	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests Receives: Procedure: Lombar Punction; Radiation: Magnetic Resonance Imaging (MRI); Radiation: Positron-Emission Tomography (TEP) /(FDG); Other: Psychiatric tests; Other: Neuropsychological Tests; Genetic: Apolipoprotein (ApoE) detection
BD/CD -	Active comparator	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests Receives: Procedure: Lombar Punction; Radiation: Magnetic Resonance Imaging (MRI); Radiation: Positron-Emission Tomography (TEP) /(FDG); Other: Psychiatric tests; Other: Neuropsychological Tests; Genetic: Apolipoprotein (ApoE) detection
a-MCI	Active comparator	Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests Receives: Procedure: Lombar Punction; Radiation: Magnetic Resonance Imaging (MRI); Radiation: Positron-Emission Tomography (TEP) /(FDG); Other: Psychiatric tests; Other: Neuropsychological Tests; Genetic: Apolipoprotein (ApoE) detection

What is being measured

The primary outcome is the main question the study is designed to answer.

Functionnal/Cognitive evaluation
Global cognitive evaluation :
MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL.
Measured: Half an hour
Psychatric evaluation
Semi-directive psychiatric interview.
Measured: 15 minutes
Psychatric evaluation
Scales for thymus evaluation : GDS, YMRS, BPRS, STAI
Measured: 15 minutes
Brain MRI
Enable neuropsychological evaluation.
Measured: 40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Jul 2018

First posted26 Jul 2016 (estimated)
Study startJul 2015
Primary completionJul 2018 (estimated)
Study completionJul 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Senile PlaquesStudies of the same condition, open and under way.
More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02843906
Sponsor's protocol ID: 38RC13.217
Acronym: BIPAGE
Status last verified: Jul 2016
First submitted: 11 May 2016
Last updated: 26 Jul 2016
Results posted: No
Data monitoring committee: No

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.
PubMed 11725216
Amieva H, Le Goff M, Millet X, Orgogozo JM, Peres 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.
PubMed 19067364
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. doi: 10.1111/j.1600-0447.2005.00570.x.
PubMed 15992392
Chetelat G, Eustache F, Viader F, De La Sayette V, Pelerin A, Mezenge 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. doi: 10.1080/13554790490896938.
PubMed 15804920
Chetelat 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. doi: 10.1016/s0035-3787(06)75104-9. French.
PubMed 17028562
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. doi: 10.1126/science.8346443.
PubMed 8346443
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.
PubMed 19719786
Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lovblad 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.
PubMed 21394788
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.
PubMed 21563239
Ewers M, Buerger K, Teipel SJ, Scheltens P, Schroder J, Zinkowski RP, Bouwman FH, Schonknecht 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. doi: 10.1212/01.wnl.0000286944.22262.ff.
PubMed 18071141
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.
PubMed 20049742
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. doi: 10.1111/j.1600-0404.1995.tb07029.x.
PubMed 7639073
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.
PubMed 18691766
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. doi: 10.1016/s0165-0327(02)00004-6.
PubMed 12547295
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. doi: 10.1136/jnnp.2003.031773.
PubMed 15548477

Want to know more?

COHEN CL Lora, Doctor

33476766089

lcohen@chu-grenoble.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Senile Plaques trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?
ClinicalTrials.gov ID: NCT02843906
Acronym / sponsor ID: BIPAGE / 38RC13.217
Conditions: Senile Plaques, Tau Proteins, Alzheimer Disease, Bipolar Disorders, Mild Cognitive Impairment
Keywords: alzheimer disease, bipolar disorders, mild cognitive impairement
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 180 participants (estimated)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
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
Study start: Jul 2015
Primary completion: Jul 2018 (estimated)
Study completion: Jul 2018 (estimated)
First posted: 26 Jul 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
BD/CD +	Active comparator	Procedure: Lombar Punction, Radiation: Magnetic Resonance Imaging (MRI), Radiation: Positron-Emission Tomography (TEP) /(FDG), Other: Psychiatric tests, Other: Neuropsychological Tests, Genetic: Apolipoprotein (ApoE) detectionLombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
BD/CD -	Active comparator	Procedure: Lombar Punction, Radiation: Magnetic Resonance Imaging (MRI), Radiation: Positron-Emission Tomography (TEP) /(FDG), Other: Psychiatric tests, Other: Neuropsychological Tests, Genetic: Apolipoprotein (ApoE) detectionLombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
a-MCI	Active comparator	Procedure: Lombar Punction, Radiation: Magnetic Resonance Imaging (MRI), Radiation: Positron-Emission Tomography (TEP) /(FDG), Other: Psychiatric tests, Other: Neuropsychological Tests, Genetic: Apolipoprotein (ApoE) detectionLombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests

Who may qualify

Ages: 60 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lombar Punctioncerebrospinal fluid testing at screening and M36	Procedure or surgery	BD/CD +, BD/CD -, a-MCI
Magnetic Resonance Imaging (MRI)MRI done at screening and M36	Radiation	BD/CD +, BD/CD -, a-MCI
Positron-Emission Tomography (TEP) /(FDG)TEP/FDG done at screening and M36	Radiation	BD/CD +, BD/CD -, a-MCI
Psychiatric tests	Other	BD/CD +, BD/CD -, a-MCI
Neuropsychological Testsdone at screening, M12, M24 and M36	Other	BD/CD +, BD/CD -, a-MCI
Apolipoprotein (ApoE) detectionApoE detection done at screening	Genetic	BD/CD +, BD/CD -, a-MCI

Primary outcome

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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Background: PubMed 11725216Ali 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.
Background: PubMed 19067364Amieva H, Le Goff M, Millet X, Orgogozo JM, Peres 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.
Background: PubMed 15992392Bora 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. doi: 10.1111/j.1600-0447.2005.00570.x.
Background: PubMed 15804920Chetelat G, Eustache F, Viader F, De La Sayette V, Pelerin A, Mezenge 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. doi: 10.1080/13554790490896938.
Background: PubMed 17028562Chetelat 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. doi: 10.1016/s0035-3787(06)75104-9. French.
Background: PubMed 8346443Corder 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. doi: 10.1126/science.8346443.
Background: PubMed 19719786Delaloye 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.
Background: PubMed 21394788Delaloye C, Moy G, de Bilbao F, Weber K, Baudois S, Haller S, Xekardaki A, Canuto A, Giardini U, Lovblad 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.
Background: PubMed 21563239Doring 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.
Background: PubMed 18071141Ewers M, Buerger K, Teipel SJ, Scheltens P, Schroder J, Zinkowski RP, Bouwman FH, Schonknecht 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. doi: 10.1212/01.wnl.0000286944.22262.ff.
Background: PubMed 20049742Fagan 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.
Background: PubMed 7639073Hindley 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. doi: 10.1111/j.1600-0404.1995.tb07029.x.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

COHEN CL Lora, Doctor contact

33476766089

lcohen@chu-grenoble.fr

BOUGEROL BT Thierry, Professor principal investigator

University Hospital, Grenoble

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact COHEN CL Lora, Doctor (33476766089, lcohen@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functionnal/Cognitive evaluation (time frame: Half an hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02843906, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.