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Predictive Value of Biomarkers of the Alzheimer's Disease (AD) in Elderly Patients With New-onset Epilepsy (BIOMALEPSIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861846
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Beyond 60 years, the prevalence of epilepsy is estimated at approximately 1% and increases with age. In these patients, the etiology of epilepsy is unknown in 25% of cases, even up to 55% after 65 years. Although new-onset epilepsy in the elderly is associated with a vascular disease in 50% of cases, the hypothesis of an ongoing neurodegenerative process, including an Alzheimer's disease (AD), is also common. However, investigators do not have any marker that might help to identify the patients who develop epilepsy after 60 years and who might be, despite a normal cognitive functioning, already engaged in the pathophysiological process of AD.

A number of data suggest a link between the pathophysiological process of AD and epileptogenesis:

(i) a third of patients with epilepsy develops MA, (ii) the occurrence of epilepsy in AD is an aggravating factor for cognition, (iii) in animal models of AD, the relationship between neuronal hyperexcitability and amyloid deposits is bidirectional, the amyloid protein has a pro-seizure effect and the presence of epilepsy increases the amyloid deposits, (iv) in these models, the administration of an antiepileptic drug protects from deterioration of cognition, (v) the close relationship between amyloid and neuronal hyperexcitability might be mediated by the inflammatory processes associated with AD, and particularly the microglial activation which role in epileptogenesis has been shown elsewhere.

Investigators hypothesize that in a subgroup of patients who develop epilepsy after 60 years, the occurrence of epilepsy might reflect the presence of an ongoing amyloid pathology. Our goal is to identify through biomarkers of AD in the cerebrospinal fluid of patients who develop an epilepsy after 60 years with normal MRI and normal cognition those at high risk of later developing clinically defined AD.

Identifying patients with amyloid pathology which would be expressed through epilepsy before the onset of cognitive dysfunction might help to adapt both the management of seizures and of the cognitive dysfunction.


Condition or disease Intervention/treatment Phase
Epilepsy Biological: profile of CSF biomarkers of AD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Value of Biomarkers of the Alzheimer's Disease (AD) in Elderly Patients With New-onset Epilepsy
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Presence of biomarkers of AD in cerebrospinal fluid
Patients older than 60 years, with normal brain MRI and with normal cognitive functioning who demonstrate a profile of CSF biomarkers of AD suggestive of biological AD
 Biological: profile of CSF biomarkers of AD
dosage of biomarker of AD


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint was the number of patients in a population of subjects older than 60 years with new-onset epilepsy but without cognitive impairment whose profile of the CSF biomarkers of the AD is suggestive of an AD. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. changes in episodic verbal memory at 2 years [ Time Frame: 2 years ]
    Evolution of RL/RI-16 score between inclusion and 2 years of follow-up

  2. changes in visual recognition memory at 2 years [ Time Frame: 2 years ]
    Evolution of DMS 48 score between inclusion and 2 years of follow-up

  3. Evolution of DO 80 score [ Time Frame: 2 years ]
    Evolution of semantic memory at 2 years: Evolution of DO 80 score between inclusion and 2 years follow-up

  4. Evolution of categorical influences [ Time Frame: 2 years ]
    Evolution of semantic memory at 2 years: Evolution of categorical influences between inclusion and 2 years follow-up

  5. Evolution of TOP 10 score [ Time Frame: 2 years ]
    Evolution of semantic memory at 2 years: Evolution of TOP 10 score between inclusion and 2 years follow-up

  6. Changes in monthly frequency of seizures at 2 years [ Time Frame: 2 years ]
    Evolution of monthly frequency of seizures between inclusion and 2 years of follow-up


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 60 years
  • Patients with newly diagnosed epilepsy according to the latest criteria of the International League against Epilepsy.
  • MMSE ≥ 28/30.
  • Patients with or without cognitive complaints.
  • Patients whose brain MRI did not reveal significant abnormalities outside slight cortical atrophy.
  • Patients in whom the lumbar puncture did not revealed abnormalities suggestive of an infectious disease or a limbic encephalitis.
  • Patient with adequate visual and auditory skills, an oral and written language in French available to clinical and neuropsychological assessment.
  • Patient who have given its written consent.

Exclusion Criteria:

  • Previous history of epilepsy before age 60 years.
  • Patient with against-indication to MRI (pacemaker, ferromagnetic clips, mechanical heart valves, intra-cochlear implants, intraocular foreign body, skin or other) or refusing MRI.
  • Presence of an abnormality in brain MRI.
  • Patients with diagnostic criteria for dementia of Alzheimer's disease, vascular dementia, mixed dementia or frontotemporal lobar degeneration.
  • Patients with autoimmune encephalitis.
  • Patients under legal protection measure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861846


Locations
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France
Hospices Civils de Lyon
Bron, France, 69500
CHU Gabriel- Montpied
Clermont-Ferrand, France
CHU des Alpes
Grenoble, France
CHU Hôpital Nord
Saint-Étienne, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: Aurélie RICHARD-MORNAS, Doctor Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02861846    
Other Study ID Numbers: 69HCL16-0041
2016-A00563-48 ( Other Identifier: ID-RCB )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
epilepsy
Alzheimer
biomarkers
predictive value
Additional relevant MeSH terms:
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Alzheimer Disease
Epilepsy
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders