Epilepsy in Alzheimer's Disease: Effect on Disease Progression

NCT04131491 | Unknown

• 1 other identifier: UZB-NEU-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a long-term, prospective, interventional study to investigate the role and prevalence of subclinical epileptiform activity in the hippocampus in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD). The investigators would like to investigate whether subclinical epileptiform activity in the hippocampus is more prevalent in patients with MCI, compared to healthy controls and to evaluate its effects on cognitive decline. Evolution of cognitive decline will be assessed over a time period of two years.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Prevalence, expressed as percentage, of subclinical epileptiform activity in MCI due to AD patients, compared to healthy controls.

  Comparison of prevalence of subclinical epileptiform activity (measured by LTM-EEG and MEG)

  Patients will have their investigations at inlcusion within a time frame of 8 weeks. Healthy Volunteers will have their investigations at inclusion within a time frame of 4 weeks.

• Odds ratio for conversion to clinical AD when comparing MCI patients with and without subclinical signs of epilepsy at the baseline evaluation.

  Odds ratio of conversion (measured by neuropsychological examination).

  Patients will have their investigations at inlcusion (time frame: 8 weeks), after 1 year (time frame: 4 weeks) and after 2 years (time frame: 4 weeks).

Study Arms (2)

Patients with Mild Cognitive Impairment (MCI) due to AD

OTHER

Neuropsychological investigation, lumbar puncture, long term-EEG monitoring and/or MEG-EEG, magnetic resonance imaging (MRI), blood sample with deep genetic profiling and Apolipoprotein E (APOE) determination.

Procedure: Lumbar puncture

Healthy volunteers

OTHER

Neuropsychological investigation, lumbar puncture, long term-EEG monitoring and/or MEG-EEG, MRI, blood sample with deep genetic profiling and APOE determination.

Procedure: Lumbar puncture

Interventions

Lumbar puncture PROCEDURE

Lumbar puncture for AD biomarker fluid analysis

Healthy volunteers; Patients with Mild Cognitive Impairment (MCI) due to AD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cognitive concern reflecting a change in cognition reported by patient or informant or clinician
• Objective evidence of impairment in one or more cognitive domains, typically including memory.
• Preservation of independence in functional abilities
• Not demented

You may not qualify if:

• Age \< 18 years old
• Pregnancy
• Expected death due to illness within 2 years
• Pacemaker or other ferromagnetic material that is not MRI compatible
• Other neurodegenerative or cerebrovascular disease
• Pattern compatible with Normal Pressure Hydrocephalus (NPH) (clinically, imaging)
• Epilepsy
• Multiple sclerosis or other demyelinating disease
• Depression, psychosis or other mental disease
• Use of anti-epileptic drugs
• Alcohol or substance abuse
• Korsakoff syndrome
• Symptomatic liver disease
• Uncontrolled thyroid disorders
• Untreated HIV or syphilis

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Jette, 1090, Belgium

RECRUITING

Related Publications (1)

• Nous A, Seynaeve L, Feys O, Wens V, De Tiege X, Van Mierlo P, Baroumand AG, Nieboer K, Allemeersch GJ, Mangelschots S, Michiels V, van der Zee J, Van Broeckhoven C, Ribbens A, Houbrechts R, De Witte S, Wittens MMJ, Bjerke M, Vanlersberghe C, Ceyssens S, Nagels G, Smolders I, Engelborghs S. Subclinical epileptiform activity in the Alzheimer continuum: association with disease, cognition and detection method. Alzheimers Res Ther. 2024 Jan 23;16(1):19. doi: 10.1186/s13195-023-01373-9.

  PMID: 38263073 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Sebastiaan Engelborghs, MD, PHD

CONTACT

+32 476 37 24; sebastiaan.engelborghs@uzbrussel.be

Amber Nous, MD

CONTACT

+32 474 94 38; amber.nous@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: February 12, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)