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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02843906
• Collaborator: University Hospital, Tours (Other), Assistance Publique - Hôpitaux de Paris (Other), University Hospital, Marseille (Other), Hospices Civils de Lyon (Other), Centre Hospitalier Universitaire de Besancon (Other), Central Hospital, Nancy, France (Other), University Hospital, Clermont-Ferrand (Other), Versailles Hospital (Other), University Hospital, Montpellier (Other), Reims University Hospital (Other), Centre Hospitalier Princesse Grace (Other)
• Enrollment: 180
• Location: 1
• Arms: 3
• Duration (Months): 36
• Patients Per Site Per Month: 5

Study Details

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.

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2015
• Anticipated Primary Completion Date: Jul 1, 2018
• Anticipated Study Completion Date: Jul 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Functionnal/Cognitive evaluation [Half an hour]

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

2. Psychatric evaluation [15 minutes]

   Semi-directive psychiatric interview.

3. Psychatric evaluation [15 minutes]

   Scales for thymus evaluation : GDS, YMRS, BPRS, STAI

4. Brain MRI [40 minutes]

   Enable neuropsychological evaluation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital, Tours	Tours		France	37000

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

• Principal Investigator: BOUGEROL BT Thierry, Professor, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT02843906
• Other Study ID Numbers: 38RC13.217
• First Posted: Jul 26, 2016
• Last Update Posted: Jul 26, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by University Hospital, Grenoble: alzheimer disease; bipolar disorders; mild cognitive impairement
• Additional relevant MeSH terms: Alzheimer Disease; Disease; Plaque, Amyloid; Cognitive Dysfunction; Bipolar Disorder

Study Results

No Results Posted as of Jul 26, 2016