40 Participants Needed

Cannabinoid Medication for Alzheimer's Disease

(CALM-IT Trial)

Recruiting at 2 trial locations
CC
Overseen ByCALM-IT Coordinating Centre
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sunnybrook Health Sciences Centre
Must be taking: Cognitive enhancers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires that if you are taking cognitive-enhancing medications, your dosage must be stable for at least 3 months before joining. You cannot change psychotropic medications shortly before or during the trial, and you must stop using anticonvulsant medications and strong inducers of CYP3A4 at least 14 days before starting the trial.

What data supports the effectiveness of the drug JZP541 for Alzheimer's disease?

While there is no direct data on JZP541, similar drugs like memantine, which is used for moderate to severe Alzheimer's disease, have shown effectiveness in improving cognitive function. This suggests that JZP541 might also be beneficial for Alzheimer's patients.12345

Is cannabinoid medication safe for humans?

Cannabinoid medications, including those with CBD and THC, have been studied for their safety in humans, showing potential benefits like reducing inflammation and protecting brain cells. However, more clinical studies are needed to fully understand their safety and optimal use, especially in older adults with Alzheimer's disease.678910

How is the drug JZP541 different from other Alzheimer's treatments?

JZP541 is unique because it targets the endocannabinoid system, which may help protect brain cells, reduce inflammation, and support brain repair mechanisms, unlike current treatments that do not address these aspects.7891112

What is the purpose of this trial?

CALM-IT is a Randomized, double-blind, placebo-controlled cross-over clinical trial. Safety and efficacy of cannabidiol (CBD) capsules assessed for managing agitation in patients with AD and to identify novel biomarkers of agitation severity and treatment response.

Research Team

KL

Krista L. Lanctot, PhD

Principal Investigator

Sunnybrook Research Institute

GM

Giovanni Marotta

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for people aged 55+ with Alzheimer's Disease who experience significant agitation. Participants must have a stable dose of cognitive-enhancing meds for 3 months, and a caregiver able to assist. They should not have certain liver issues, recent drug or alcohol dependence, uncontrolled cardiovascular disease, or be using cannabis products.

Inclusion Criteria

I am 55 or older. If female, I am post-menopausal or will follow birth control rules. If male, I will use contraception if my partner can have children.
I have been diagnosed with significant agitation.
I can give my consent or have someone who can decide for me.
See 5 more

Exclusion Criteria

I have used marijuana or cannabinoid products within the last week.
I have not had a stroke in the last 3 months.
My heart's electrical activity (QT interval) is longer than normal or I have risk factors for a specific heart rhythm problem.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment Phase 1

Participants receive either CBD or placebo for the first treatment phase

9.5 weeks
6 visits (in-person), 4 visits (telephone)

Treatment Phase 2

Participants cross-over to the opposite treatment (CBD or placebo) for the second treatment phase

9.5 weeks
6 visits (in-person), 4 visits (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • JZP541
Trial Overview The CALM-IT study tests JZP541 against a placebo in managing Alzheimer's-related agitation. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real medicine versus the placebo during the trial.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants randomized to the placebo will be titrated up to a maximum dose of 800 mg/day
Group II: CBDExperimental Treatment1 Intervention
Participants randomized to the CBD arm will be titrated up to a maximum dose of 800 mg/day

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Weston Brain Institute

Collaborator

Trials
13
Recruited
990+

Findings from Research

In a one-year study involving 51 older adults with Alzheimer's disease, nizatidine did not show any significant effect on delaying cognitive decline compared to a placebo.
Despite initial hopes for nizatidine as a treatment to slow symptom progression in Alzheimer's, the trial results indicate it is ineffective for this purpose.
H2 histamine receptor blockade in the treatment of Alzheimer disease: a randomized, double-blind, placebo-controlled trial of nizatidine.Carlson, MC., Tschanz, JT., Norton, MC., et al.[2019]
In a 6-month observational study involving patients with moderate to severe Alzheimer's disease, memantine treatment at 20 mg/day led to significant improvements in cognitive function and daily activities, with 78.8% of patients showing improvement or stabilization.
Memantine was well-tolerated by patients, reinforcing its safety profile and efficacy as previously established in controlled clinical trials.
Memantine (Ebixa) in clinical practice - results of an observational study.Calabrese, P., Essner, U., Forstl, H.[2013]
In a double-blind, randomized, placebo-controlled trial involving subjects with multiple sclerosis and cognitive impairment, memantine did not show any significant improvement in cognitive performance compared to placebo, as measured by the PASAT and CVLT-II tests.
While memantine was generally safe with no serious adverse events reported, it was associated with increased fatigue and neurological side effects, and family members reported less cognitive improvement and more neuropsychiatric symptoms in those taking memantine compared to those on placebo.
Memantine for cognitive impairment in multiple sclerosis: a randomized placebo-controlled trial.Lovera, JF., Frohman, E., Brown, TR., et al.[2021]

References

H2 histamine receptor blockade in the treatment of Alzheimer disease: a randomized, double-blind, placebo-controlled trial of nizatidine. [2019]
Memantine (Ebixa) in clinical practice - results of an observational study. [2013]
Memantine for cognitive impairment in multiple sclerosis: a randomized placebo-controlled trial. [2021]
4.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Double-blind, controlled phase II study of a 5-HT6 receptor antagonist, SB-742457, in Alzheimer's disease. [2022]
[Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial]. [2018]
Oral THC: CBD cannabis extract in main symptoms of Alzheimer disease: agitation and weight loss. [2023]
Regulatory role of the endocannabinoid system on glial cells toward cognitive function in Alzheimer's disease: A systematic review and meta-analysis of animal studies. [2023]
Alzheimer's disease; taking the edge off with cannabinoids? [2018]
Therapeutic properties of multi-cannabinoid treatment strategies for Alzheimer's disease. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The Use of Cannabinoids in Treating Dementia. [2022]
Role of interleukin 1-beta in the inflammatory response in a fatty acid amide hydrolase-knockout mouse model of Alzheimer's disease. [2019]
Cannabinoids for treatment of Alzheimer's disease: moving toward the clinic. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security