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New treatment option for Down Syndrome
Official title LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome
ClinicalTrials.gov ID: NCT07234695
What this study is testing
What is Levetiracetam 500mg?
Levetiracetam 500mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for down syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome. It will also analyze whether it can delay the neurodegeneration associated with this disease.
- Phase 3: a large, late-stage study
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Diagnosed with Down Syndrome (DS), either with a karyotype or a compatible typical phenotype.
- Age over 40 years at time of screening.
- Symptomatic Alzheimer's Disease (AD) dementia, based on change in functionality and neuropsychological tests' results. Different cut-off points will...
- Willing and able caregiver who has daily contact with the study subject.
- people and caregivers must be able to comply with the prescribed regimen of study treatment throughout the course of the study and meet a minimum...
You likely can't join if
- ) are allowed as long as the dose is stable for 30 days prior to screening.
- people and/or their caregivers must be able to provide their consent before participating in any study-related procedures. Exclusion Criteria:
- Cognitive changes attributable to causes other than AD (for example, but not limited to, uncorrected visual or hearing deficit, severe, untreated...
- Previous history of adult-onset epileptic seizures (over 18 years old).
- Treatment with any kind of antiepileptic drugs, benzodiazepines, narcotics.
- Significant comorbidities or analytical abnormalities, such as:
See the full eligibility criteria
- Diagnosed with Down Syndrome (DS), either with a karyotype or a compatible typical phenotype.
- Age over 40 years at time of screening.
- Symptomatic Alzheimer's Disease (AD) dementia, based on change in functionality and neuropsychological tests' results. Different cut-off points will be established to diagnose dementia depending on the level of...
- Willing and able caregiver who has daily contact with the study subject.
- people and caregivers must be able to comply with the prescribed regimen of study treatment throughout the course of the study and meet a minimum required time commitment of biannual in-person visits.
- Any concurrent treatment for AD approved by the European Medicines Agency (EMA) must be stable for at least 30 days prior to screening and at least 60 days prior to study day 1. Other medications (except for those...
- ) are allowed as long as the dose is stable for 30 days prior to screening.
- people and/or their caregivers must be able to provide their consent before participating in any study-related procedures. Exclusion Criteria:
- Cognitive changes attributable to causes other than AD (for example, but not limited to, uncorrected visual or hearing deficit, severe, untreated sleep apnea or uncontrolled thyroid disorders).
- Previous history of adult-onset epileptic seizures (over 18 years old).
- Treatment with any kind of antiepileptic drugs, benzodiazepines, narcotics.
- Significant comorbidities or analytical abnormalities, such as:
- Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or how well it works of the study (eg, moderate and/or severe untreated obstructive sleep apnea, clinically...
- Severe renal dysfunction (creatinine clearance \< 30 mL/min), which would affect serum levetiracetam levels, or any other medical condition which is determined by the investigators to potentially create an undue risk...
- Concomitant or past history psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid...
- Significant risk of suicide, defined using the C-SSRS as the subject answering "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behavior within the past 12 months.
- Deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, judged to be clinically significant by the investigator.
- Participation in another clinical trial within 3 months of screening.
- Hypersensitivity to the active ingredient, other pyrrolidone derivatives, or any of the excipients
- Pregnant and breastfeeding patients
The study team makes the final eligibility decision.
Where it's taking place
- Granada, Andalusia, Spain
- Donostia / San Sebastian, Basque Country, Spain
- Santander, Cantabria, Spain
- Barcelona, Catalonia, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Granada, Andalusia, Spain; Donostia / San Sebastian, Basque Country, Spain; Santander, Cantabria, Spain; Barcelona, Catalonia, Spain; Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.