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Neuroinflammation and Cognitive Decline in Alzheimer Disease | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

Neuroinflammation and Cognitive Decline in Alzheimer Disease

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

NCT02377206•University Hospital, Tours

View on ClinicalTrials.gov

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)

Eligibility

Age

50 - No limit years

Sex

ALL

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)
+5 more criteria

Locations (3)

university hospital of Nantes

Nantes, France

University Hospital of Rennes

Rennes, France

University Hospital of Tours

Tours, France

Key Dates

Start Date

April 6, 2016

Primary Completion Date

December 4, 2019

Completion Date

December 4, 2019

Last Updated

September 14, 2022

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

ADAS-Cog evaluation

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neuroinflammation and Cognitive Decline in Alzheimer Disease

Inclusion Criteria

Exclusion Criteria

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