Neuroinflammation and Cognitive Decline in Alzheimer Disease

Early Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Other: ADAS-Cog evaluation

• Registration Number: NCT02377206
• Lead Sponsor: University Hospital, Tours

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)

Study Timeline

• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-03
• Study Start: 2016-04-06
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alzheimer Disease	ADAS-Cog evaluation	Alzheimer Disease People ADAS-Cog evaluation PET imaging with \[18F\]DPA-714

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Relationship passessment between [18F]DPA-714 fixing	Inclusion and 34 months

Trial Locations

Locations (3)

university hospital of Nantes; 🇫🇷 Nantes, France

University Hospital of Rennes; 🇫🇷 Rennes, France

University Hospital of Tours; 🇫🇷 Tours, France