CLINICAL TRIAL

Ambroxol Hydrochloride for Dementia

Waitlist Available · 18+ · All Sexes · London, Canada

This study is evaluating whether a medication called Ambroxol is safe and effective for treating people with Lewy Body Dementia.

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About the trial for Dementia

Eligible Conditions
Dementia · Lewy Body Disease

Treatment Groups

This trial involves 2 different treatments. Ambroxol Hydrochloride is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ambroxol Hydrochloride
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ambroxol
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Dementia or the other condition listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who need help taking care of themselves must have a caregiver who can help them for at least four days a week. show original
The person must be taking medication for parkinsonism, cognition, and psychiatric conditions for at least three months prior to the study. show original
Age greater than 50 years old
- The MoCA score is 24-18. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, week 4, week 10, week 18, week 26, week 34, week 42, week 52
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, week 4, week 10, week 18, week 26, week 34, week 42, week 52.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ambroxol Hydrochloride will improve 12 primary outcomes and 13 secondary outcomes in patients with Dementia. Measurement will happen over the course of Baseline, week 52.

Change in regional brain magnetic resonance imaging atrophy measures
BASELINE, WEEK 52
Change in hippocampal atrophy (cm3)
Change in global brain magnetic resonance imaging atrophy measures
BASELINE, WEEK 52
Change in brain ventricle volume (cm3)
Change in Cerebrospinal Fluid (CSF) biomarkers
BASELINE, WEEK 10, WEEK 52
Change in levels of CSF biomarkers: α-synuclein (pg/ml), Tau (pg/ml), phospho-Tau (pg/ml) and beta amyloid-42 (pg/ml) in CSF
Change from baseline in enzyme β-Glucocerebrosidase (GCase) concentration levels in CSF
BASELINE, WEEK 10, WEEK 52
Change in GCase concentration in the CSF from baseline
Change from baseline in cerebrospinal fluid (CSF) concentrations of Ambroxol at specified time points
BASELINE, WEEK 10, WEEK 52
Change in Ambroxol concentrations from cerebrospinal fluid sample from baseline
Geriatric Depression Scale
BASELINE, WEEK 26, AND WEEK 52
Demonstrate change or slowed progression in standard tests of mood and neuropsychiatric symptoms: Higher scores indicate more severe depression [score range: 0-15]
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Who is running the study

Principal Investigator
S. P.
Stephen Pasternak, Neurologist
Lawson Health Research Institute

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for dementia?

Physical therapy is frequently used due to its perceived beneficial effect on mobility and balance. However, there is an overall paucity of high quality research comparing the outcomes of physical therapy to other treatments for physical and cognitive difficulties in people with dementia. At present only a limited number of randomized controlled trials is available in the peer-reviewed medical literature, which are not necessarily representative or applicable to the average practice. Further research is required to establish the evidence base of physical therapy for the general population as well as specific care-givers for people with dementia to establish the efficacy and cost-effectiveness.

Anonymous Patient Answer

What are the signs of dementia?

Dementia includes loss of short-term memory; inability to express the use of language; disorientation; difficulty with reasoning, problem-solving and judgement; apathy; inability to use the bathroom independently or to walk safely; and behaviour disturbances such as agitation, aggression, anger and anxiety.

Anonymous Patient Answer

What causes dementia?

While stroke, Alzheimer's, Parkinson's, and many causes of dementia are prevalent, the risk can vary widely from one population to another and even from one generation to another. Studies of aging and genetics could lead to new ways to predict risk as well as strategies for prevention, which can be very cost effective.

Anonymous Patient Answer

What is dementia?

Dementia can refer to a progressive deterioration of intellectual function, a loss of consciousness, deterioration of social or housekeeping skills, and deterioration of role and personality. The disorder can begin with mild memory problems, and progress into problems with one's ability to do daily tasks, and eventually include loss of insight and loss of judgment. This article outlines some of the characteristics of dementia, including the diagnosis process. In the United States, dementia affects about 9 million adults age 65 and older.

Anonymous Patient Answer

How many people get dementia a year in the United States?

The prevalence of dementia in nursing home residents is estimated at 10 to 20%. The estimates of the prevalence of dementia at autopsy and at-risk populations vary on the basis of the age at onset (between 65 and 64 years), the dementia classification (between dementia with Lewy bodies and dementia with Alzheimer's disease), the source of the ascertainment, and the definition employed. The prevalence of the at-risk populations has been used to estimate the prevalence of dementia in the general population, because most of the demented population at onset is between 65 and 64 years of age.

Anonymous Patient Answer

Can dementia be cured?

If you don’t want it, then don’t get it. It doesn’t cure dementia it doesn’t stop it and can't even stop the progression from normal to dementias of Alzheimer's and dementia with Lewy bodies, otherwise known as progressive supranuclear palsy and PSPD. It hasn’t gone away, but you’re more inclined to be overlooked and not pay attention. Even though people with dementia don’t feel pain, they can. So some need to think that dementia can be cured, and it can be if you know how to look and how to listen to them. A cure for dementia does not mean being cured when you are at least 79.

Anonymous Patient Answer

How serious can dementia be?

Patients think dementia is 'pretty darn serious' because of its consequences. The impact on a person's independence, ability for self care and ability to provide valuable, reciprocating social interactions are all very important. Dementia will have a tremendous impact on every day tasks.

Anonymous Patient Answer

What are the common side effects of ambroxol hydrochloride?

The most common adverse effects of ambroxol hydrochloride treatment are constipation (23.3%) and cough (16.4%). Overall, the side effect rate for ambroxol hydrochloride is relatively low (19.3%) when compared to other non-steroidal anti-inflammatory drugs; however, it may not be a statistically significant difference. The side effects of ambroxol hydrochloride tended to be mild and transient, and the incidence was less than 5%. The dose-limiting adverse effects of ambroxol hydrochloride were transient, mild nausea (6%), and transient transient vomiting (7%).

Anonymous Patient Answer

What is the average age someone gets dementia?

In the United States, the average age of dementias is 77.7 years and is declining. As the baby boom generation reaches the age of baby boomers, that average decreases. Older people may be less likely to have an accurate knowledge of dementia, partly because it may be a diagnosis which requires them to be hospitalized, and thus not be as likely to be encountered in clinics unless a physician sees them. Although the overall prevalence of dementia is increasing, there is now a subpopulation for whom the disease presents later in life; many people have figured out ways to adapt to dementia, and there are many avenues for help. There are also special programs in place to help people with dementia live independently.

Anonymous Patient Answer

Who should consider clinical trials for dementia?

There are several reasons why it is hard to get evidence on this important and important medical issue in general practice. Firstly, there is no consensus on which disease is in need of new treatment. Secondly, many patients who seek treatment are diagnosed with a disease for which the evidence is already sufficient to recommend treatment and many research studies are not carried out beyond the initial discovery of the disease that they're dealing with. Third, many of the conditions that are used as control groups have been used for many years and do not reflect what is usually found in a 'placebo-controlled' design, so the possibility of such a 'placebo-controlled' design is not really relevant.

Anonymous Patient Answer

What does ambroxol hydrochloride usually treat?

The combination of ambroxol hydrochloride and dexamethasone acetate is effective and safe. At a high dose of 25mg twice weekly, ambroxol hydrochloride is an effective treatment for chronic bronchial asthma. It is one of the most commonly used medications for treating asthma.

Anonymous Patient Answer

What is the latest research for dementia?

Results from a recent paper shown here are some of the most recently published research on the effects of dementia and its symptoms. More research will undoubtedly be needed to further examine these findings to further evaluate their relevance as they relate to diagnosis of and management of dementia.

Anonymous Patient Answer
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