CLINICAL TRIAL

Nabilone for Alzheimer Disease

Recruiting · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients.

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About the trial for Alzheimer Disease

Eligible Conditions
Alzheimer Disease · Psychomotor Agitation · Agitation

Treatment Groups

This trial involves 2 different treatments. Nabilone 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 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nabilone
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
Nabilone
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Males or females ≥55 years of age; females must be post-menopausal
sMMSE ≤24
If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months
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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 (0 Weeks) to 8 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline (0 Weeks) to 8 Weeks.
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 Nabilone will improve 1 primary outcome, 6 secondary outcomes, and 1 other outcome in patients with Alzheimer Disease. Measurement will happen over the course of Baseline (0 Weeks) to 8 Weeks.

Global Change - Alzheimer's Disease Cooperative Study - Clinical Global Impression of Severity/Change (ADCS-CGIS/C)
BASELINE (0 WEEKS) TO 8 WEEKS
A commonly-used clinician-rated scale that quantifies disease severity and clinical change (worsening, no change, or improvement), based on information regarding the patient's medical history, cognition, behaviour, and function. Numerical scores are not assigned.
Pain - Pain Assessment Checklist for Seniors with Limited Ability to Communicate-II (PACSLAC-II)
BASELINE (0 WEEKS) TO 8 WEEKS
A 31-item observer-rated scale assessing facial expressions, activity/body movements, social/personality/mood indicators and mental status changes. Scores range from 0-31 points, with a higher score indicating a worse outcome.
Cognition - Standardized Mini-Mental State Examination (sMMSE)
BASELINE (0 WEEKS) TO 8 WEEKS
Measures global cognition, and assesses orientation to time and place, immediate recall, short-term verbal memory, calculation, language, and construct ability. Scores range from 0-30 points, with a lower score indicating a worse outcome.
Agitation - Cohen-Mansfield Agitation Inventory (CMAI)
BASELINE (0 WEEKS) TO 8 WEEKS
A 29-point scale that measures agitation in two dimensions, verbal and physical, each of which having two poles, aggressive and non-aggressive. Scores range from 29-203 points, with a higher score indicating a worse outcome. This includes the CMAI IPA Agitation Score & CMAI IPA Delphi Modification, which are derived from the CMAI.
Weight
BASELINE (0 WEEKS) TO 8 WEEKS
Behaviour - Neuropsychiatric Inventory - Nursing Home (NPI-NH)
BASELINE (0 WEEKS) TO 8 WEEKS
A widely used assessment of behaviour disturbances in dementia, including: apathy, agitation, delusions, hallucinations, depression, euphoria, aberrant motor behaviour, irritability, disinhibition, anxiety, sleeping, and eating. The frequency and severity of these symptoms are judged on a 4-point and 3-point scale, respectively. Scores range from 0-144 points, with a higher score indicating a worse outcome.
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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 is the primary cause of alzheimer disease?

While some cases are familial, almost three-quarters of those with Alzheimer disease are not family members. The lack of family association implies at least part of Alzheimer disease must be caused by environmental factors.

Anonymous Patient Answer

What are the signs of alzheimer disease?

Symptoms of AD usually appear before the age of 60 years. Symptoms include difficulties remembering names and numbers, difficulty speaking that gets worse over time. More than half the people with AD show changes in judgment and a loss of personality; they may appear to be drunk on their own. People with AD may also have delusions and forget what they planned to say or do, especially about financial matters. Their physical mobility deteriorates in the final stages of the disease, making them less able to take care of themselves. People have difficulty swallowing. People with Alzheimer's disease may often forget which way is up in familiar locations. Some people with AD may also be unable to sleep and may stay awake all or part of the night.

Anonymous Patient Answer

Has nabilone proven to be more effective than a placebo?

Since Nabilone was not found to be more effective than a placebo, these results support the concept that the cognitive benefits of Nabilone may not be related to psychotropic action.

Anonymous Patient Answer

What is alzheimer disease?

Most people diagnosed with Alzheimer's disease have at least some impairment in gait. Individuals with Alzheimer's disease may be at risk of falling. Cognitive impairment and fatigue are also strongly associated with high-risk falls. In fact, patients with Alzheimer's disease who have falls have poorer outcomes than those with falls who do not fall. Results from a recent clinical trial reinforce the importance of fall prevention and prompt clinical interventions aiming to identify and improve risk of falling amongst patients diagnosed with Alzheimer's disease.

Anonymous Patient Answer

How many people get alzheimer disease a year in the United States?

The number of people developing AD per year continues to increase; however, the majority of people with AD do not live to the age of 80.

Anonymous Patient Answer

Can alzheimer disease be cured?

With aggressive, effective treatment and the proper follow-up of the patient, most patients with Alzheimer's disease can live and function independently for their remaining years. The outlook for alzheimer patients decreases with the increasing age of the patient.

Anonymous Patient Answer

What causes alzheimer disease?

This article highlights the important role that the environmental triggers play as a cause of Alzheimer disease, irrespective of the genetic and biochemical aetiologies. For those in their 60s, the environmental causes are more clearly understood and deserve urgent and continued attention and awareness. However, in the earlier stages of the disease, the environmental exposures must be taken into account. Thus, public health measures, research and more focused research into the epidemiological and pathophysiological consequences of the environmental causes are essential in the fight against the disease.

Anonymous Patient Answer

What are common treatments for alzheimer disease?

These common treatments include medications and rehabilitation therapy. However, many medications are unavailable in developing nations and rehabilitation is rarely accessible, even for those who receive it. New medicines are being developed and trials are being conducted. However, there is not enough evidence to tell us how effective these medicines are in Alzheimer's disease. There are no randomized, controlled trials examining the effectiveness of treatments in Alzheimer's disease. Clinicians must assess risk and benefit. If there is no benefit, treatment should be discontinued. With dementia, clinicians should be aware of the common medications used to treat the disease.

Anonymous Patient Answer

What is nabilone?

The mechanism of the action of nabilone could be determined by its antagonistic action on muscarinic (mAChr) receptors that is present at high frequency in the human brain. The findings also showed that nabilone was able to inhibit muscarinic induced chloride secretion in rat tracheal smooth muscle cells, suggesting that it may have potential for treating bronchial hyperpermeability.

Anonymous Patient Answer

Is nabilone safe for people?

Nabilone should only be used as part of a well-planned regimen in patients who need to be on a low-risk medication schedule. It should always be prescribed with caution in patients with pre-existing neurological diagnoses, or a recent history of depression or mania.

Anonymous Patient Answer

How serious can alzheimer disease be?

This is the first in-depth report of the effect of age and disease severity on cognitive, psychiatric, and physical consequences of AD. There was a strong association between physical symptom burden and cognitive impairment. Findings from a recent study imply that AD patients with severe psychological distress and physical symptoms may be at risk for an increased rate of cognitive decline early in the course of their illness. Findings from a recent study support the view that there is a spectrum of AD severity, from mild cognitive impairment to severe dementia.

Anonymous Patient Answer

What is the latest research for alzheimer disease?

The field of dementia research has progressed rapidly, with an average of 10 articles published each week in the past 30 years. The new generation of investigators who entered this promising field of science from the past decade will lead a new era of breakthroughs in our understanding of Alzheimer disease and its prevention and treatment.

Anonymous Patient Answer
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