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New treatment option for Dementia With Lewy Bodies
Official title Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial
ClinicalTrials.gov ID: NCT04588285
What this study is testing
What is Ambroxol?
Ambroxol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for dementia with lewy bodies.
Also referred to as Mucosolvan.
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
- This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in participants diagnosed with prodromal and early dementia with Lewybodies (DLB).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 18 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Male or female.
- Age ≥ 50 and ≤ 85 years of age.
- Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).
- MMSE score\>=15
- Able and willing to provide informed consent prior to any study related assessments and procedures at screening visit 1.
You likely can't join if
- Current treatment with anticoagulants (e.g. warfarin) that might preclude safe completion in the opinion of the Investigator.
- Current use of investigational medicinal product or participation in another treatment clinical trial or who have done so within 30 days prior to the...
- 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 day 1 to day 550/Month 18.
- Significant known lower spinal malformations or other spinal abnormalities that would preclude lumbar puncture.
- History of known sensitivity to the study medication, ambroxol or its excipients (lactose monohydrate, granulated microcrystalline cellulose...
See the full eligibility criteria
- Male or female.
- Age ≥ 50 and ≤ 85 years of age.
- Confirmed diagnosis of Dementia with Lewy Bodies (DLB) or Mild Cognitive Impairment in DLB (DLB-MCI).
- MMSE score\>=15
- Able and willing to provide informed consent prior to any study related assessments and procedures at screening visit 1.
- 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 BID (day 15-21), 315 mg TID (day 22-28) and 420 mg...
- Able to travel to the participating study site.
- 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...
- 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...
- Current treatment with anticoagulants (e.g. warfarin) that might preclude safe completion in the opinion of the Investigator.
- Current use of investigational medicinal product or participation in another treatment 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 day 1 to day 550/Month 18.
- Significant known lower spinal malformations or other spinal abnormalities that would preclude lumbar puncture.
- History of known sensitivity to the study medication, ambroxol or its excipients (lactose monohydrate, granulated microcrystalline cellulose, copovidone and magnesium stearate) in the opinion of the investigator that...
- 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; 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...
- Any clinically significant or unstable psychiatric, 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...
- Impaired renal function
- Moderate/Severe hepatic impairment
- 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...
- Major depression, delirium or psychosis not related to DLB.
- Metastatic cancer or terminal illness.
- Planned major surgery or other major treatments during study period that will interfere with study-obligations.
The study team makes the final eligibility decision.
Where it's taking place
- Haugesund, Haugesund, Norway
- Bergen, Norway
- Hågån, Norway
- Lørenskog, Norway
- Oslo, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 18 months 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, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haugesund, Haugesund, Norway; Bergen, Norway; Hågån, Norway; Lørenskog, Norway; Oslo, Norway; Stavanger, Norway and 2 more location(s). 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.