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

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What is this study about?

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.

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

2 Medication adjustment – Week 2

Dosage increases to 120 mg three times per day

Duration: Days 8-14

3 Medication adjustment – Week 3

Dosage changes to 315 mg twice per day

Duration: Days 15-21

4 Medication adjustment – Week 4

Dosage increases to 315 mg three times per day

Duration: Days 22-28

5 Final medication phase

Dosage increases to 420 mg three times per day

Duration: Days 29-550 (approximately 18 months)

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway
Hymby Fqorc Hq Haugesund Norway
Hwiphsupjckh Dxsvmdelw Sgptjeg Av Bergen Norway
Ajbiahrn Ujihnrwflr Huvggzgv Lorenskog Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
01.05.2021

Trial locations

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.

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.

Trial ID:
2024-510720-38-00
Protocol code:
2019-002855-41
NCT ID:
NCT04588285
Trial Phase:
Therapeutic exploratory (Phase II)

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