Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia (Ata-GAD)

March 21, 2024 updated by: Hospices Civils de Lyon
Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bron, France, 69677
        • Recruiting
        • Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patient with cerebellar ataxia and GAD antibody

Description

Inclusion Criteria:

  • neurological symptoms with GAD antibody
  • GAD antibody in sera and/or CSF
  • patient with cerebellar ataxia

Exclusion Criteria:

  • tested positive to another antibody.
  • no data
  • any test in paraneoplastic neurological syndrome and autoimmune encephalitis center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anti-GAD encephalitis
This is a non-interventional study involving clinical data. This data are information of medical follow up on patient like diagnosis, symptoms, biological results, cancer, treatments.
Describe the clinical and demographic characteristics of patients with anti-GAD65 antibody associated cerebellar ataxia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GAD Patient
Time Frame: Baseline
Description of clinical data in patients with cerebellar syndrome associated with anti-GAD antibodies
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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