EpilepsyBIOMALEPSIENCT02861846
Predictive Value of Biomarkers of the Alzheimer's Disease (AD) in Elderly Patients With New-onset Epilepsy
A study testing profile of CSF biomarkers of AD in people with Epilepsy, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- profile of CSF biomarkers of AD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Mar 2017to 16 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hospices Civils de Lyon
Bron, 69500
CHU Gabriel- Montpied
Clermont-Ferrand
CHU des Alpes
Grenoble
CHU Hôpital Nord
Saint-Etienne
About this study
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:
Read more
(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.
- Conditions
- Epilepsy
- Being tested
- profile of CSF biomarkers of AD
- Keywords
- epilepsy, Alzheimer, biomarkers, predictive value
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
profile of CSF biomarkers of ADBiological
dosage of biomarker of AD
| Study group | Role | What they receive |
|---|---|---|
| Presence of biomarkers of AD in cerebrospinal fluid | Other | 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 Receives: Biological: profile of CSF biomarkers of AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (6)
changes in episodic verbal memory at 2 years
Evolution of RL/RI-16 score between inclusion and 2 years of follow-up
Measured: 2 years
changes in visual recognition memory at 2 years
Evolution of DMS 48 score between inclusion and 2 years of follow-up
Measured: 2 years
Evolution of DO 80 score
Evolution of semantic memory at 2 years: Evolution of DO 80 score between inclusion and 2 years follow-up
Measured: 2 years
Evolution of categorical influences
Evolution of semantic memory at 2 years: Evolution of categorical influences between inclusion and 2 years follow-up
Measured: 2 years
Evolution of TOP 10 score
Evolution of semantic memory at 2 years: Evolution of TOP 10 score between inclusion and 2 years follow-up
Measured: 2 years
Changes in monthly frequency of seizures at 2 years
Evolution of monthly frequency of seizures between inclusion and 2 years of follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start1 Mar 2017
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie RICHARD-MORNAS, Doctor, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861846
- Sponsor's protocol ID
- 69HCL16-0041
- Other IDs
- 2016-A00563-48
- Acronym
- BIOMALEPSIE
- Status last verified
- Mar 2023
- First submitted
- 4 Jul 2016
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Biomarkers of the Alzheimer's Disease (AD) in Elderly Patients With New-onset Epilepsy
- ClinicalTrials.gov ID
- NCT02861846
- Acronym / sponsor ID
- BIOMALEPSIE / 69HCL16-0041
- Conditions
- Epilepsy
- Keywords
- epilepsy, Alzheimer, biomarkers, predictive value
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presence of biomarkers of AD in cerebrospinal fluid | Other | Biological: profile of CSF biomarkers of ADPatients 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| profile of CSF biomarkers of ADdosage of biomarker of AD | Biological | Presence of biomarkers of AD in cerebrospinal fluid |
Primary outcome
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
6 secondary outcomes
changes in episodic verbal memory at 2 years
Time frame: 2 years
changes in visual recognition memory at 2 years
Time frame: 2 years
Evolution of DO 80 score
Time frame: 2 years
Evolution of categorical influences
Time frame: 2 years
Evolution of TOP 10 score
Time frame: 2 years
Changes in monthly frequency of seizures at 2 years
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie RICHARD-MORNAS, Doctor study director
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing profile of CSF biomarkers of AD in people with Epilepsy, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.