Neuroinflammation and Cognitive Decline in Alzheimer Disease (NICAD)

Regional University Hospital Center (CHRU)

Status and phase

Completed

Early Phase 1

Conditions

Alzheimer Disease

Treatments

Other: ADAS-Cog evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT02377206

PRTS13-CH / NICAD

Details and patient eligibility

About

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).

Full 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)

Enrollment

24 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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