Geriatric Patients
Study register · detail Kohortenstudie · Geriatric Patients · 2023

Oral THC: CBD cannabis extract in main symptoms of Alzheimer disease: agitation and weight loss.

Clear benefit GRADE Very low
Samplen = 30 Pat.
Duration12 weeks
EndpointNPI-Q
Blindingn.a.
DesignKohortenstudie
Cannabinoidkombination
THC:CBD44:1
Routeoral
Key finding

THC:CBD cannabis extract showed significant reduction in agitation, apathy, irritability, sleep disorders and eating disorders (p<0.0001) as well as a decrease in aggressive behaviour and cognitive impairment in 45% of patients.

Summary

n=30 Alzheimer's patients (65–90 years), Bedrocan® (THC22%:CBD0.5%) twice daily for 12 weeks; NPI-Q reduction in agitation/apathy/irritability/sleep-/eating disorders (p<0.0001), CMAI reduction in aggressive behaviours (p<0.0001), MMSE improvement in cognitive impairment in 45% (p<0.0001). Limitations: small cohort, no control group, self-administered questionnaires.

P
PopulationAdults with Alzheimer's dementia (mild to severe), n=30, age 65–90 years
I
InterventionOral THC:CBD cannabis extract (Bedrocan® 22% THC, 0,5% CBD, in olive oil 50 ml), twice daily
O
OutcomeSignificant reduction in agitation, apathy, irritability, sleep and eating disorders (NPI-Q, p<0,0001); reduction in aggressive behaviours (CMAI, p<0,0001); significant improvement in cognitive function in 45% of patients (MMSE, p<0,0001)
Confidence in the evidence
Very low

The lowest GRADE level, the effect estimate remains uncertain.

Downgraded for
Imprecision
Quality profile
Sample size
Blinding
Effect size Clear benefit
Citations / year
Authors
Palmieri B, Vadala M
DOI 10.7417/ct.2023.5009
Design: Kohortenstudie
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Abstract
Objectives: Ten million new cases of dementia are recorded annually worldwide, with agitation and idiopathic weight loss being the most common symptoms. Several pharmacological therapies have emerged in recent years, but the clinical use of cannabis extracts in older patients with AD is constantly growing. This retrospective, analytical, observational, spontaneous trial aimed to enhance the clinical action of Thc: CBD cannabis extract administration in AD patients with severe symptoms such as agitation, weight loss, cognitive impairment, and sleep disturbance. Methods: Thirty patients (9 men and 21 women) diagnosed with mild, moderate, or severe AD, aged 65-90 years, appealing to our Second Opinion Medical Consultation (Modena, Italy), were enrolled and required to use oil-diluted cannabis extract, Bedrocan(R) (22% THC, 0.5% CBD, Olive Oil 50 ml), twice a day for 12 weeks. The efficacy of cannabinoid therapy was evaluated at baseline and 12 weeks after therapy, employing three self-administered questionnaires completed by the parents of the enrolled patients: NPI-Q, CMAI, and Mmse. Key Findings: The NPI-Q demonstrated a reduction (p<0.0001) in agitation, apathy, irritability, sleep disturbances, and eating disturbances, consequently improving caregiver distress. Levels of physically and verbally aggressive behaviours, measured using the CMAI questionnaire, were lower (p<0.0001) in all patients. The MMSSE questionnaire confirmed a significant decrease (p<0.0001) in cognitive impairment in 45% of the patients. Conclusion: Our anecdotical, spontaneous, and observational study demonstrated the efficacy and safety of oil-diluted cannabis extract in patients with AD. The limitations of our study are: 1) small patient cohort, 2) absence of control group, 3) self-administered questionnaires that are the most practical but not objective instruments to assess the neurologic functions of AD patients.

The impediment to action advances action. — Marcus Aurelius