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

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Senile Plaques; Tau Proteins; Bipolar Disorders
• Intervention / Treatment: Procedure: Lombar Punction; Radiation: Magnetic Resonance Imaging (MRI); Radiation: Positron-Emission Tomography (TEP) /(FDG); Other: Psychiatric tests; Other: Neuropsychological Tests; Genetic: Apolipoprotein (ApoE) detection

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37000
    • Recruiting
    • University Hospital, Tours
    • Contact: Camus CV Vincent, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Assistance Publique - Hôpitaux de Paris; Hospices Civils de Lyon; University Hospital, Montpellier; Central Hospital, Nancy, France; University Hospital, Clermont-Ferrand; Centre Hospitalier Universitaire de Besançon; Versailles Hospital; University Hospital, Tours; University Hospital, Marseille; Reims University hospital; Centre Hospitalier Princesse Grace
• Investigators: Principal Investigator: BOUGEROL BT Thierry, Professor, University Hospital, Grenoble

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 22, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: alzheimer disease; bipolar disorders; mild cognitive impairement
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Dementia; Tauopathies; Cognition Disorders; Bipolar and Related Disorders; Disease; Alzheimer Disease; Cognitive Dysfunction; Bipolar Disorder; Plaque, Amyloid
• Other Study ID Numbers: 38RC13.217