BridgeMD
A phase IIa multicentre randomized controlled double blind clinical trial to demonstrate clinical efficacy on cognitive, neuropsychiatric and functional outcomes of Ambroxol in New and Early patients with prodromal and mild Dementia with Lewybodies
EU CTIS ID: 2024-510720-38-00
What this study is testing
To confirm the effect of the IMP ambroxol in participants diagnosed with DLB measured by MMSE-NR3 as the primary outcome measure.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 50 and ≤ 85 years of age, both genders
- A female participant is eligible to participate if she is of: ● Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 consecutive months of spontaneous amenorrhea, at least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. In questionable cases, menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 25.8 – 134.8 IU/L and oestradiol < 201 pmol/l at entry. ● Women of child-bearing potential must use accepted contraceptive methods (listed below), and must have a negative serum at screening visit 1 and urine pregnancy tests at subsequent visits if applicable. An additional pregnancy test will be performed, and results obtained, prior to administration of the first dose of ambroxol.
- Caregiver needs to be > 18 years when signing the informed consent form.
- Confirmed diagnosis of Dementia with Lewybodies (DLB) including Mild Cognitive Impairment in DLB (DLB-MCI).
- MMSE score>=15 at screening
- Able and willing to provide informed consent prior to any study related assessments and procedures.
You likely can't join if
- Current treatment with anticoagulants (e.g. warfarin, argatroban, dabigatraneteksilat, rivaroksaban, apiksaban, edoksaban).
- All participants of child bearing potential in the opinion of the Investigator that would preclude participation in the study and who do not agree to use double-barrier birth control or abstinence while participating in the study and for 2 weeks following the last dose of the study drug.
- clinically significant or unstable medical or surgical condition that in the opinion of the PI or PI-delegated clinician may put the participant at risk when participating in the study or may influence the results of the study or affect the participant’s ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests. Such conditions may include: a) Impaired renal function defined by eGFR<=30 b) Moderate/Severe hepatic impairment defined by Child-Pugh score >1 c) A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, pulmonary embolism, coronary revascularisation that occurred within 6 months prior to the screening visit. d) Major stroke e) Major depression defined clinically or by GDS-15 >=11 points or delirium or psychotic disorder unrelated to DLB. f) Cancer, history of metastatic cancer, terminal illness or clinically significant disease within ≤5 years, except for adequately treated basal cell skin cancer.
- Planned major surgical treatment during the study period.
- Current use of investigational medicinal product or participation in another interventional clinical trial or who have done so within 30 days prior to the first dose in the current study.
- Exposure to more than three investigational medicinal products within 12 months prior to the first dose in the current study.
See the full eligibility criteria
Who can join
- 1. Age ≥ 50 and ≤ 85 years of age, both genders
- A female participant is eligible to participate if she is of: ● Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 consecutive months of spontaneous amenorrhea, at least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation. In questionable cases, menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 25.8 – 134.8 IU/L and oestradiol < 201 pmol/l at entry. ● Women of child-bearing potential must use accepted contraceptive methods (listed below), and must have a negative serum at screening visit 1 and urine pregnancy tests at subsequent visits if applicable. An additional pregnancy test will be performed, and results obtained, prior to administration of the first dose of ambroxol.
- Caregiver needs to be > 18 years when signing the informed consent form.
- Confirmed diagnosis of Dementia with Lewybodies (DLB) including Mild Cognitive Impairment in DLB (DLB-MCI).
- MMSE score>=15 at screening
- Able and willing to provide informed consent prior to any study related assessments and procedures.
- Capable of complying with all study procedures.
- Willing to provide blood samples for genetic analyses of APOE and GBA.
- Willing and able to self-administer or administer by a caregiver oral ambroxol medication, from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)).
- Contact with caregiver at least 3 times a week, to ensure sufficient information from the caregiver regarding participants status and possible change in condition.
- Able to travel to the participating study site.
What rules you out
- Current treatment with anticoagulants (e.g. warfarin, argatroban, dabigatraneteksilat, rivaroksaban, apiksaban, edoksaban).
- All participants of child bearing potential in the opinion of the Investigator that would preclude participation in the study and who do not agree to use double-barrier birth control or abstinence while participating in the study and for 2 weeks following the last dose of the study drug.
- clinically significant or unstable medical or surgical condition that in the opinion of the PI or PI-delegated clinician may put the participant at risk when participating in the study or may influence the results of the study or affect the participant’s ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG), or laboratory tests. Such conditions may include: a) Impaired renal function defined by eGFR<=30 b) Moderate/Severe hepatic impairment defined by Child-Pugh score >1 c) A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, decompensated congestive heart failure, pulmonary embolism, coronary revascularisation that occurred within 6 months prior to the screening visit. d) Major stroke e) Major depression defined clinically or by GDS-15 >=11 points or delirium or psychotic disorder unrelated to DLB. f) Cancer, history of metastatic cancer, terminal illness or clinically significant disease within ≤5 years, except for adequately treated basal cell skin cancer.
- Planned major surgical treatment during the study period.
- Current use of investigational medicinal product or participation in another interventional clinical trial or who have done so within 30 days prior to the first dose in the current study.
- Exposure to more than three investigational medicinal products within 12 months prior to the first dose in the current study.
- Confirmed dysphagia that would preclude self-administration of ambroxol up to 6 tablets daily for the duration of this study.
- History of known sensitivity to the study medication, ambroxol or its excipients (lactose monohydrate, granulated microcrystalline cellulose, silicon dioxide,magnesium stearate and Bitrex/Denatonium Benzoate in the opinion of the investigator that contraindicates their participation.
- History of known rare hereditary disorders of galactose Intolerance: Lapp lactase deficiency or glucose-galactose malabsorption.
- History of illegal substance abuse, drug abuse or alcoholism in the opinion of the Investigator that would preclude participation in the study.
- Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of the study drug.
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.