Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics (OLDMUS)

Little is known about old MS patients. In a previous work, systematic search in Bordeaux, Strasbourg and Dijon university hospital regional MS center databases European Database for Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS) patients in the 3 databases. Data analysis showed that MS may switch off in the very old patients with mild progression and very few relapses. The project is to continue this preliminary work and extend it with a systematic study of MS in the elderly.

The scientific aims: To add new insights into long lasting MS natural history in the growing population of elderly patients with MS.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

Detailed Description

75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP) which includes more than 50 000 MS patients in France. Accuracy of these patients' data from 65 to 75 years old will be thereafter checked and completed in 3 French MS centers: Lyon, Rennes and Bordeaux, participating to this database directly from the patients' clinical files. From these 3 MS centers around 150 MS patients from 75 to 77 years old are expected to be analysed on site.

The data wich will be retrieved for these patients are: irreversible disability status scale progression, relapses, Magnetic Resonance Imaging (MRI) data, CSF data, Lublin classification of type of MS, McDonald 2005 and 2010 criteria, date and age at beginning of progression, characteristics and modality of relapses and clinical impairment at the beginning of the disease, treatments used, treatment failures and side effects, co morbidity, Barthel index, EuroQol-5D (EQ-5D), cognitive impairment (SDMT test), social life data and socio economic data. To the investigator's knowledge this will be the first systematic description of very old MS patients with data on long term natural history of MS and characteristics in this population of elderly MS patients.

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux - Pellegrin - service de neurologie
  • Bron, France
    • Hôpital neurologique - Pierre Wertheimer
  • Rennes, France
    • CHU de Rennes - service de neurologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 77 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" which includes more than 50 000 MS patients in France.

Description

Inclusion Criteria:

• Patients with McDonald 2001, 2005 or 2010 criteria of multiple sclerosis 75 to 77 years old MS patients at the time of inclusion
• Patients whose beginning of MS was before 65 years old or 65 years old
• Patients who signed OFSEP 's consent

Exclusion Criteria:

• Patients whose clinical data cannot be entered or for whom too much clinical data are missing
• Alive patients older than 77 years or younger than 75 years the day of the inclusion in the study
• Patients died before 65 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Old MS patients; 75 to 77 years old MS patients whose disease began at 65 years old or earlier will be retrieved from the "Observatoire français de la sclérose en plaques" (OFSEP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of MS evolution with disability progression (irreversible Disability Status Scale) in 75 to 77 years Old MS Patients from the age of 65 years-old to present time	Time to reach the irreversible Kurtzke disability status scale (DSS) score 4, 6 and 7	At inclusion (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of clinical relapses in 75 years Old or Older MS Patients from the age of 65 years-old to present time		At inclusion (day 0)
Description of the clinical characteristics at 75 years Old	Clinical conversion to secondary progressive MS date	At inclusion (day 0)
Description of the Cerebral MRI at 75 years Old	Number of lesions on T2 sequence if <9, number of new T2 lesions, Number of Gadolinium enhancing lesions, T1-Hypointense Lesions (T1 Black Holes), MRI Barkhof Criteria and number of periventricular lesions if <3,	At inclusion (day 0)
Description of the paraclinical characteristics at 75 years Old	Distance walked (with or without help)	At inclusion (day 0)
Description of the paraclinical characteristics at 75 years Old	Barthel index	At inclusion (day 0)
Socio-demographic data	sex	At inclusion (day 0)
Socio-demographic data	age	At inclusion (day 0)
Socio-demographic data	department of residence	At inclusion (day 0)
Description of the treatments at 75 years Old	Treatments of multiple sclerosis	At inclusion (day 0)
Description of the treatments at 75 years Old	Failures treatments of multiple sclerosis	At inclusion (day 0)
Description of the treatments at 75 years Old	Side effects of treatments and other concomitant treatments	At inclusion (day 0)
Measure of health-related quality of life at 75 years Old	EQ-5D Instruments	At inclusion (day 0)
Evaluation of cognitive functions at 75 years Old	Symbol digit modalities test (SDMT) test	At inclusion (day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Novartis; Observatoire Français de la sclérose en plaques (OFSEP)
• Investigators: Principal Investigator: Jean-Christophe OUALLET, MD, PhD, CHU de Bodeaux; Study Chair: Sandra VUKUSIC, Prof., Observatoire Français de la sclérose en plaques (OFSEP)

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Actual): September 23, 2020
• Study Completion (Actual): September 23, 2020

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Geriatric population; EDMUS; OFSEP
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CHUBX 2014/02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No