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

Primary Purpose

Senile Plaques, Tau Proteins, Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lombar Punction
Magnetic Resonance Imaging (MRI)
Positron-Emission Tomography (TEP) /(FDG)
Psychiatric tests
Neuropsychological Tests
Apolipoprotein (ApoE) detection
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Senile Plaques focused on measuring alzheimer disease, bipolar disorders, mild cognitive impairement

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

BD/CD +

BD/CD -

a-MCI

Arm Description

Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests

Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests

Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 11, 2016
Last Updated
July 22, 2016
Sponsor
University Hospital, Grenoble
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
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1. Study Identification

Unique Protocol Identification Number
NCT02843906
Brief Title
Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?
Acronym
BIPAGE
Official Title
Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Senile Plaques, Tau Proteins, Alzheimer Disease, Bipolar Disorders, Mild Cognitive Impairment
Keywords
alzheimer disease, bipolar disorders, mild cognitive impairement

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BD/CD +
Arm Type
Active Comparator
Arm Description
Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
Arm Title
BD/CD -
Arm Type
Active Comparator
Arm Description
Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
Arm Title
a-MCI
Arm Type
Active Comparator
Arm Description
Lombar punction, RMI, TEP/FDG, ApoE detection, psychiatric tests, neuropsychological tests
Intervention Type
Procedure
Intervention Name(s)
Lombar Punction
Intervention Description
cerebrospinal fluid testing at screening and M36
Intervention Type
Radiation
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
MRI done at screening and M36
Intervention Type
Radiation
Intervention Name(s)
Positron-Emission Tomography (TEP) /(FDG)
Intervention Description
TEP/FDG done at screening and M36
Intervention Type
Other
Intervention Name(s)
Psychiatric tests
Intervention Type
Other
Intervention Name(s)
Neuropsychological Tests
Intervention Description
done at screening, M12, M24 and M36
Intervention Type
Genetic
Intervention Name(s)
Apolipoprotein (ApoE) detection
Intervention Description
ApoE detection done at screening
Primary Outcome Measure Information:
Title
Functionnal/Cognitive evaluation
Description
Global cognitive evaluation : MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL.
Time Frame
Half an hour
Title
Psychatric evaluation
Description
Semi-directive psychiatric interview.
Time Frame
15 minutes
Title
Psychatric evaluation
Description
Scales for thymus evaluation : GDS, YMRS, BPRS, STAI
Time Frame
15 minutes
Title
Brain MRI
Description
Enable neuropsychological evaluation.
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
COHEN CL Lora, Doctor
Phone
33476766089
Email
lcohen@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BOUGEROL BT Thierry, Professor
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camus CV Vincent, Professor

12. IPD Sharing Statement

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

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