Neuroinflammation and Cognitive Decline in Alzheimer Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-06

Study Completion Date

2019-12-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PET Imaging of the Translocator Proteine Ligands (TSPO) With [18 F] DPA-714 Biomarker of NeuroInflammation in Cognitive Decline (NIDECO)

NCT02062099

Memory Complaint Mild Cognitive Impairment Alzheimer Disease

COMPLETED PHASE1

Central and Systemic Inflammation in Alzheimer's Disease

NCT01775696

Alzheimer's Disease

COMPLETED

FluoroAv45 Imaging Research-in Alzheimer's Disease

NCT01325259

Alzheimer's Disease Mild Cognitive Impairment

COMPLETED PHASE2

Evaluation of the Neuroinflammation Pattern of BAY85-8102 F-18, DPA-714 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of F 18, DPA-714 in Healthy Volunteers

NCT01009359

Diagnostic Imaging

COMPLETED PHASE1

Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.

NCT03863041

Memory Complaint Alzheimer Disease Phosphorylated Metabolism Profile +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alzheimer Disease

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

Group Type EXPERIMENTAL

ADAS-Cog evaluation

Intervention Type OTHER

\[18F\]DPA-714 PET imaging

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADAS-Cog evaluation

\[18F\]DPA-714 PET imaging

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No