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New treatment option for Lewy Body Dementia
Official title tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
ClinicalTrials.gov ID: NCT06785948
What this study is testing
- What it's testing
- The goal of this pilot prospective study is to evaluate the effect of tDCS on psychotic-like symptoms in patients with Lewy Body Dementia (LBD). The main questions it aims to answer are: What is the effect of tDCS on neuropsychiatric symptoms, especially psychotic-like symptoms?
- 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 60 and older
You may be able to join if
- Male or Female, aged over 60,
- Diagnosed with a neurodegenerative pathology of the DLB type, at a moderate stage, according to the McKeith and al. (2017) criteria
- No change in antiparkinsonian or psychotropic medications, or cholinesterase inhibitors, for a period of one month prior to inclusion,
- Mini Mental State Examination (MMSE) \> 15,
- Composite score called "psychotic factor" (corresponding to the sum of the psychotic-type symptoms sub-scores from the NPI [12]) greater than 0,
You likely can't join if
- History of alcoholism, drug addiction or neurological diseases such as brain trauma, epilepsy, encephalitis, intracranial normal-pressure...
- Concomitant major psychiatric illness,
- Significant physical illness or comorbidities
- History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration,
- Patient under guardianship or curators
See the full eligibility criteria
- Male or Female, aged over 60,
- Diagnosed with a neurodegenerative pathology of the DLB type, at a moderate stage, according to the McKeith and al. (2017) criteria
- No change in antiparkinsonian or psychotropic medications, or cholinesterase inhibitors, for a period of one month prior to inclusion,
- Mini Mental State Examination (MMSE) \> 15,
- Composite score called "psychotic factor" (corresponding to the sum of the psychotic-type symptoms sub-scores from the NPI [12]) greater than 0,
- Presence of a family caregiver,
- Sufficient written and oral expression in French,
- Written informed consent signed by the patient and his/her family caregiver
- History of alcoholism, drug addiction or neurological diseases such as brain trauma, epilepsy, encephalitis, intracranial normal-pressure hydrocephalus, etc. which may lead to cognitive impairment,
- Concomitant major psychiatric illness,
- Significant physical illness or comorbidities
- History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration,
- Patient under guardianship or curators
The study team makes the final eligibility decision.
Where it's taking place
- Monaco, Monaco
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monaco, Monaco. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.