Neuroinflammation and Cognitive Decline in Alzheimer Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).

Detailed Description
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The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714 , and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by ADAS-Cog and MMSE scores). (DPA-714 : N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide)

Official Title
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Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: ADAS-Cog evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Age more than 50 years (included) necessary knowledge of French (write and oral) to do neuropsychological tests Study level upper (or equal) than 7 years (considering first year of grammar-school as start) People with Alzheimer Disease defined as National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) standards : Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included) Social security affiliation. Exclusion Criteria: MMSE score lower than 15 and upper or equal to 26 Evolutive disease which could possibly had consequences on central nervous system Inflammatory disease or evolutive neoplasia and/or C reactive protein (CRP) upper than 10mg/L Chronic use of alchohol and/or drug Serious depression defined by Montgomery Asberg Depression Rating Scale (MADRS) score higher than 18 Surgical or medical condition in the last 3 months Long term treatment which could possibly interfere with inflammatory process (especially the month before PET [18F]DPA-714 imaging). Treatment by N-Methyl-D-Aspartate antagonist Treatment by Minocycline Treatment by benzodiazepine (especially the month before PET [18F]DPA-714 imaging) (Zolpidem, zopiclone and loprazolam excepted) Anomaly at neurological examination which is not a classical symptom Contraindication to magnetic resonance imaging (RMI) Florbetapir[18F] hypersensibility Participation to an other experimental protocol with drug. people under guardianship

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alzheimer Disease<br>Alzheimer Disease People ADAS-Cog evaluation PET imaging with [18F]DPA-714 | Other: ADAS-Cog evaluation<br>* [18F]DPA-714 PET imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the neuroinflammation measured by fixing and layout of [18F]DPA-714 between 3 groups of patients : subjects suffering from Alzheimer disease light to mild stage, amnesiac MCI and patients suffering from isolated cognitive complaint |  | inclusion and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship passessment between [18F]DPA-714 fixing |  | Inclusion and 34 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, [18F]DPA-714, cognitive decline