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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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


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




Primary Outcome Measures :
  1. Functionnal/Cognitive evaluation [ Time Frame: Half an hour ]

    Global cognitive evaluation :

    MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL.


  2. Psychatric evaluation [ Time Frame: 15 minutes ]
    Semi-directive psychiatric interview.

  3. Psychatric evaluation [ Time Frame: 15 minutes ]
    Scales for thymus evaluation : GDS, YMRS, BPRS, STAI

  4. Brain MRI [ Time Frame: 40 minutes ]
    Enable neuropsychological evaluation.



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

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
Publications:

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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