No announcement yet.

Pot Pill Doesn't Lessen Dementia Symptoms - MedPage Today

  • Filter
  • Time
  • Show
Clear All
new posts

  • Pot Pill Doesn't Lessen Dementia Symptoms - MedPage Today

    Action Points

    • A low-dose medical marijuana pill wasn't effective at mitigating symptoms of dementia.
    • Note that that the 4.5-mg daily dose was well-tolerated, so a dosage increase may boost efficacy.

    A low-dose "pot pill" wasn't effective at mitigating symptoms of dementia, researchers reported.

    In a randomized controlled trial, patients who were taking either placebo or oral tetrahydrocannabinol (THC, Namisol) had similar reductions in neuropsychiatric symptoms, reported Geke van den Elsen, MD, of Radboud University Medical Center in Nijmegen, and colleagues.

    However, they pointed out that the 4.5-mg daily dose was well-tolerated, so a dosage increase may boost efficacy, they wrote online in Neurology.

    Van den Elsen and colleagues noted that many patients with dementia will experience neuropsychiatric symptoms, but management of those symptoms is a challenge.

    Pharmacologic management includes acetylcholinesterase inhibitors and antidepressants, but these have a suboptimal risk-benefit profile, they explained. As for nonpharmacologic treatments, they added.

    But some early evidence suggests that THC, the active component in marijuana, can improve symptoms such as agitation and nocturnal motor activity in patients with Alzheimer's disease. Since endocannabinoid receptors are present in several brain regions, as well as in the cells and organs of the immune system, the researchers said THC could have an impact on emotion, cognition, and behavior.

    Since firm evidence of the efficacy and safety of THC and other cannabinoids in dementia patients are lacking, they conducted a study of 50 patients who were randomized to either placebo or to 1.5 mg of oral THC three times a day for 3 weeks.

    The primary outcome was change in scores on the Neuropsychiatric Inventory (NPI), assessed at baseline and at days 14 and 21 after starting treatment.

    Ultimately, they randomized 24 patients to THC and 26 patients to placebo.

    Van den Elsen and colleagues found that symptoms were reduced to a similar extent with both treatments. NPI total score decreased in both groups at both 14 days (P=0.002 for both) and 21 days (P=0.003 for THC and P=0.001 for placebo).

    "The substantial degree of improvement in the placebo group is striking, and may be due to many factors including attention and support by the study team, expectations of patients and caregivers concerning THC, and training of nursing home personnel," the researchers wrote.

    There were no differences in scores for agitation, quality of life, activities of daily living, or aberrant motor behavior, they reported, and there was no benefit when examined by community-dwelling patients or inpatients.

    The number of patients experiencing mild or moderate adverse events (AE) was similar. Adverse events occurred in 67% of patients taking THC and 54% of those in the placebo group.

    There were no changes between groups in terms of heart rate, blood pressure, and weight, and there were no differences in episodic memory function, they added.

    Also, none of the participants reported feeling "high" nor were any observed as behaving "high" by caregivers or research staff, the researchers said.

    The study did have limitations, they noted. Patients with severe aggressive behavior weren't included in the study, which may limit its generalizability.

    And the study failed to enroll the planned number of patients, despite comprehensive recruitment efforts through various healthcare settings. However, the researchers noted that the study was still powered sufficiently, and it is "very unlikely that exposure of more participants to the study interventions and assessments would have influenced our conclusion."

    They concluded that 4.5 mg daily of oral THC showed no benefit in neuropsychiatric symptoms in dementia, but it was well-tolerated, which "adds valuable knowledge to the scares evidence on THC in dementia."

    Its benign adverse event profile seen with the current dosage allows for the study of whether higher doses are efficacious and equally well tolerated, they said.

    "The observation that there was no biological signal of AEs suggests that the dosage was too low, as a psychoactive drug is rarely effective without showing any side effects," they wrote. "Therefore, our results warrant further research using higher dosages of THC in the treatment of dementia-related neuropsychiatric symptoms."

    The study was supported by the European Regional Development Fund at the Province of Gelderland.

    The study drug was provided by Echo Pharmaceuticals of the Netherlands.

    Van den Elsen and co-authors disclosed no relevant relationships with industry.

    • Reviewed by
      Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

    last updated 05.14.2015
Previously entered content was automatically saved. Restore or Discard.
Mad :mad: Stick Out Tongue :p Wink ;) Big Grin :D Embarrassment :o Smile :) Frown :( Confused :confused: Roll Eyes (Sarcastic) :rolleyes: Cool :cool: EEK! :eek:
Insert: Thumbnail Small Medium Large Fullsize Remove  

Please enter the six letters or digits that appear in the image below.

Registration Image Refresh Image