Alzheimer Disease
Conditions
Keywords
PET, [18F]DPA-714, cognitive decline
Brief summary
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
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)
Interventions
OTHERADAS-Cog evaluation
\[18F\]DPA-714 PET imaging
Sponsors
University Hospital, Tours
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Relationship passessment between [18F]DPA-714 fixing | Inclusion and 34 months |
Countries
France
Outcome results
None listed