Alzheimer Disease Clinical Trial
— BIPAGEOfficial title:
Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?
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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | July 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 80 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
France | University Hospital, Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Assistance Publique - Hôpitaux de Paris, Central Hospital, Nancy, France, Central Hospital, Versailles, Centre Hospitalier Princesse Grace, Centre Hospitalier Universitaire de Besancon, Hospices Civils de Lyon, University Hospital, Clermont-Ferrand, University Hospital, Marseille, University Hospital, Montpellier, University Hospital, Reims, University Hospital, Tours |
France,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functionnal/Cognitive evaluation | Global cognitive evaluation : MMSE (Mini-Mental State Examination), CDR, BREF, 5 word of Dubois ADL, IADL. |
Half an hour | No |
Primary | Psychatric evaluation | Semi-directive psychiatric interview. | 15 minutes | No |
Primary | Psychatric evaluation | Scales for thymus evaluation : GDS, YMRS, BPRS, STAI | 15 minutes | No |
Primary | Brain MRI | Enable neuropsychological evaluation. | 40 minutes | No |
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