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Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease

NCT05911178 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-06-13

No results posted yet for this study

Summary

This study aims to analyse, in vivo, the interplay between microglial activation and tau pathology in Alzheimer's disease (AD) using \[18F\]-DPA-714 and \[18F\]-Ro948 tracers by Position Emission Tomography (PET), and their consequences on synaptic density using \[11C\]-UCB-J, a recent PET radioligand.

By coupling advanced neuroimaging techniques in AD patients, while comparing them to controls, we will be able to study, for the first time in humans, the interaction between neuroinflammation, tau pathology, synaptic density, and their impact on AD progression. Joint analyses of peripheral immune biomarkers, carried out as a secondary objective, will further aim at defining peripheral correlates of this interplay.

Overall, we aim to refine AD subgroup classification in order to improve and to refine the design of new therapeutic trials.

Conditions

  • Alzheimer Disease

Interventions

RADIATION

[11C]-UCB-J

PET tracer binding to "SV2A" protein, used to study synaptic vesicle density.

RADIATION

[18F]-DPA-714

PET tracer binding to "TSPO" protein, used to study microglial activation.

RADIATION

[18F]-RO-948

PET tracer binding to "tau" protein, used to study the topography of tau deposition.

RADIATION

[11C]-PiB

PET tracer binding to Aβ40 and Aβ42 fibrils and insoluble plaques containing the aforementioned Aß peptides, used to study the topography of amyloid deposition.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Centre Hospitalier St Anne

    lead OTHER

Principal Investigators

  • Marie SARAZIN, MD, Prof · GHU Sainte-Anne

  • Guillaume DOROTHEE, PhD · INSERM UMRS 938

  • Michel BOTTLAENDER, PhD · Service Hospitalier Frédéric Jolit / CEA

  • Marie Claude POTIER, PhD · Institut du Cerveau et de la Moelle épinière, Hôpital Pitié-Salpêtrière

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2028-02-17
Completion
2028-04-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05911178 on ClinicalTrials.gov