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

NCT02843906 | Unknown

• 1 other identifier: 38RC13.217
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Senile Plaques; Tau Proteins; Alzheimer Disease; Bipolar Disorders; Mild Cognitive Impairment

Keywords

alzheimer disease; bipolar disorders; mild cognitive impairement

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

BD/CD +

ACTIVE COMPARATOR

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

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

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

Procedure: Lombar Punction; Radiation: Magnetic Resonance Imaging (MRI); Radiation: Positron-Emission Tomography (TEP) /(FDG); Other: Psychiatric tests; Other: Neuropsychological Tests; Genetic: Apolipoprotein (ApoE) detection

Interventions

Lombar Punction PROCEDURE

cerebrospinal fluid testing at screening and M36

BD/CD +; BD/CD -; a-MCI

Magnetic Resonance Imaging (MRI) RADIATION

MRI done at screening and M36

BD/CD +; BD/CD -; a-MCI

Positron-Emission Tomography (TEP) /(FDG) RADIATION

TEP/FDG done at screening and M36

BD/CD +; BD/CD -; a-MCI

Psychiatric tests OTHER

BD/CD +; BD/CD -; a-MCI

Neuropsychological Tests OTHER

done at screening, M12, M24 and M36

BD/CD +; BD/CD -; a-MCI

Apolipoprotein (ApoE) detection GENETIC

ApoE detection done at screening

BD/CD +; BD/CD -; a-MCI

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• University Hospital, Tours: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• University Hospital, Marseille: collaborator
• Hospices Civils de Lyon: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• Central Hospital, Nancy, France: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Versailles Hospital: collaborator
• University Hospital, Montpellier: collaborator
• Reims University hospital: collaborator
• Centre Hospitalier Princesse Grace: collaborator

Study Sites (1)

University Hospital, Tours

Tours, 37000, France

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Plaque, Amyloid; Alzheimer Disease; Bipolar Disorder; Cognitive Dysfunction

Interventions

Magnetic Resonance Spectroscopy; tetraethylpyrazine; Fluorodeoxyglucose F18; Neuropsychological Tests; Apolipoproteins; Apolipoproteins E

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates; Psychological Tests; Behavioral Disciplines and Activities; Lipoproteins; Lipids; Apoproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• BOUGEROL BT Thierry, Professor

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

COHEN CL Lora, Doctor

CONTACT

33476766089; lcohen@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: July 26, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

FR (1)