BridgeMD
Tests treatment safety and results for Alzheimer Disease
Official title Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT05926011
What this study is testing
- What it's testing
- This is a controlled investigation, with randomization of the patients, which aims at demonstrating the efficacy of device RGn600 in treating patients with mild-to-moderate Alzheimer's disease (AD). RGn600 is a non-invasive medical device which is applied on the head (helmet) and on the abdomen (abdominal belt).
- Time commitment: about 26 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85
You may be able to join if
- Male or female aged 55 to 85 years old (both included)
- Diagnosed with AD according to McKhann et al. international criteria dated 2011
- With mild-to-moderate AD, i.e., 10 ≤ MMSE score ≤ 26
- With blood analyses results (for: thyroid-stimulating hormone, vitamin B12, folate, complete blood count including platelets, electrolytes including...
- With brain Computed Tomography (CT) or/and Magnetic Resonance Imaging (MRI) scan dated less than 1 year ago in line with AD diagnosis, as deemed by...
You likely can't join if
- Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle")
- Patient deprived of liberty or hospitalized without consent
- Non-menopausal woman
- Patient taking a disease-modifying treatment such as the Leqembi® or any other disease-modifying treatment that may be authorized in France before...
- Patient living in a medical facility
- Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion
See the full eligibility criteria
- Male or female aged 55 to 85 years old (both included)
- Diagnosed with AD according to McKhann et al. international criteria dated 2011
- With mild-to-moderate AD, i.e., 10 ≤ MMSE score ≤ 26
- With blood analyses results (for: thyroid-stimulating hormone, vitamin B12, folate, complete blood count including platelets, electrolytes including calcium, creatinine, clearance, alanine aminotransferase, aspartate...
- With brain Computed Tomography (CT) or/and Magnetic Resonance Imaging (MRI) scan dated less than 1 year ago in line with AD diagnosis, as deemed by the investigator
- In case of treatment with AD symptomatic treatments (memantine and acetylcholinesterase inhibitors) and psychotropic treatments (anxiolytics, antidepressants and neuroleptics): with a stable dose of such treatments 4...
- Who has a caregiver who is sufficiently and regularly present and can help the patient throughout the investigation, as deemed by the investigator
- Affiliated to French social security
- Who provided, with his/her caregiver, a dated and signed informed consent form.
- Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle")
- Patient deprived of liberty or hospitalized without consent
- Non-menopausal woman
- Patient taking a disease-modifying treatment such as the Leqembi® or any other disease-modifying treatment that may be authorized in France before the end of the study
- Patient living in a medical facility
- Patient who experienced a surgery at the treatment application area (abdomen or head) within 3 months prior inclusion
- Patient with skin lesions on the treatment application area (abdomen or head)
- Patient with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.)
- Patient diagnosed with a stroke within 3 months prior inclusion
- Patients with ferromagnetic material (i.e., iron, nickel, cobalt or any metal alloy) on or near the head or abdomen, or implanted with a pacemaker
- Patient with a risk of epileptic seizure
- Patient with a genetic form of AD
- Patient with major physical or neurosensorial disorders that may interfere with neurological assessments
- Patient with chronic psychosis or psychotic episodes
- Patient addicted to alcohol or drugs
- Patient with known and non-supplemented vitamin B12 and folic acid deficiencies
- Patient with known untreated hypothyroidism
- Patient who participated to another investigation/study involving the use of an investigational medical device/drug within the 30 days prior inclusion
- Patient not able to meet treatment sessions as deemed by the investigator
- Patient not able to complete requested investigation assessments as deemed by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Castres, France
- Lavaur, France
- Paris, France
- Timone, France
- Toulouse, France
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 26 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, 55 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Castres, France; Lavaur, France; Paris, France; Timone, France; Toulouse, France. 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.