Recruiting

Study of Ambroxol Treatment in People with Early Stage or Mild Lewy Body Dementia

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Dementia with Lewy Bodies, including those with mild cognitive impairment related to this condition. The research aims to evaluate the effectiveness of ambroxol, a medication given as tablets, in improving cognitive function, behavior, and daily activities in people with this type of dementia.

The study will compare two groups of participants - one group will receive ambroxol tablets while the other will receive a placebo. The medication dosage will be gradually increased over several weeks, starting with lower doses and reaching the final treatment dose that will continue for 18 months. During this time, participants will take the medication three times per day.

Throughout the study, participants will be monitored for changes in their thinking abilities, memory, movement, sleep patterns, and daily functioning. The research will also look at how the medication works in people with different genetic characteristics. A caregiver must be available to help monitor the participant's condition and assist with medication intake if needed.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medication phase - Week 1
You will receive ambroxol or placebo tablets to take by mouth
Dosage: 60 mg three times per day
Duration: Days 1-7
Step 2
Medication adjustment - Week 2
Dosage increases to 120 mg three times per day
Duration: Days 8-14
Step 3
Medication adjustment - Week 3
Dosage changes to 315 mg twice per day
Duration: Days 15-21
Step 4
Medication adjustment - Week 4
Dosage increases to 315 mg three times per day
Duration: Days 22-28
Step 5
Final medication phase
Dosage increases to 420 mg three times per day
Duration: Days 29-550 (approximately 18 months)
Step 6
Regular assessments
Your thinking abilities will be evaluated using various tests
Physical movement assessments will be conducted
Sleep patterns will be monitored
Your overall condition will be regularly evaluated
Blood samples will be collected for genetic testing
Step 7
Safety monitoring
Your caregiver must maintain contact at least 3 times per week
Regular monitoring of any changes in your condition
Recording of any falls during the study period
Step 8
Study completion
Final assessments will be conducted at month 18
Evaluation of overall changes in your condition since the start of the study

Who can join the trial?

11 criteria

Age between 50 and 85 years old, both men and women can participate
For women participants: - Must be unable to have children due to surgery or menopause (no menstrual periods for 12 consecutive months) - If able to have children, must use approved birth control methods and have negative pregnancy tests during the study
Must have a caregiver who is at least 18 years old
Must have a confirmed diagnosis of Dementia with Lewy Bodies, including mild cognitive impairment form
Must score 15 or higher on the Mental State Examination test (MMSE) during screening
Must be able to provide informed consent and understand study procedures
Must be able to follow all study requirements
Must agree to provide blood samples for genetic testing
Must be able to take oral medication (ambroxol) according to the study schedule, either by themselves or with caregiver help
Must have contact with their caregiver at least 3 times per week to monitor health status
Must be able to travel to the study location for appointments

Who cannot join the trial?

15 criteria

Age below 50 or above 85 years old
Known allergies or hypersensitivity to ambroxol or similar medications
Participation in another clinical trial within the last 30 days
Severe liver problems or abnormal liver function tests
Severe kidney disease (impaired kidney function)
Uncontrolled high blood pressure (hypertension)
History of severe heart disease
Pregnancy or breastfeeding
Unable to provide informed consent
Current diagnosis of other types of dementia (memory and thinking disorders)
Taking medications that could interact with the study drug
Severe psychiatric conditions that could interfere with the study
History of alcohol or drug abuse within the past year
Unable to attend regular study visits or follow study procedures
Any condition that, in the opinion of the study doctor, makes participation unsafe

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Helse Fonna HF
Haugesund, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

Ambroxol is a medication commonly used as a mucolytic (helps break down mucus) and expectorant (helps clear airways). In this trial, it is being studied for a different purpose - to evaluate its potential benefits for people with Lewy body dementia. Research suggests that this medication might help protect brain cells and potentially slow down the progression of this type of dementia. While this is a new application for this well-known medication, it has an established safety profile from its traditional use in respiratory conditions.

Ambroxol Hydrochloride

What is already known about the treatment

Ambroxol – A medication traditionally used as a mucolytic agent that has shown promising potential in treating Dementia with Lewy Bodies (DLB) through a novel mechanism of action. It is administered orally in tablet or syrup form and is currently being investigated in clinical trials for its neuroprotective properties. The drug works by increasing the activity of an enzyme called glucocerebrosidase (GCase) in the brain, which helps reduce the accumulation of toxic proteins associated with DLB, while also demonstrating potential anti-inflammatory effects. Ambroxol belongs to the class of secretolytic agents and is being studied as a potential disease-modifying treatment for neurodegenerative conditions.

Investigated diseases

Dementia with Lewy Bodies - A progressive brain condition characterized by the buildup of protein deposits called Lewy bodies in brain cells. The disease causes a decline in thinking, reasoning, and independent function. People with this condition experience changes in attention, alertness, and visual hallucinations. Memory problems may be less noticeable in the early stages compared to Alzheimer's disease. Movement difficulties similar to Parkinson's disease, such as rigid muscles and slow movement, often occur as the disease progresses. Sleep disorders and changes in behavior are also common features of this condition.