Clinical Studies and Case Reports

On this site you will find clinical studies with cannabis or single cannabinoids in different diseases and case reports on the use of cannabis by patients.
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TitleOpen-label study of dronabinol in the treatment of refractory agitation in Alzheimerís disease: a pilot study
Author(s)Ross JS, Shua-Haim JR
Journal, Volume, IssueAbstract, American Society of Consultant Pharmacists' 34th Annual Meeting, November 12-15, 2003.
Major outcome(s)Significant reduction of agitation
IndicationAlzheimer's diseaseAbstract
MedicationDelta-9-THC

Objectives: Primary, to investigate the efficacy of two doses of dronabinol for the treatment of behavioral agitation in community-dwelling patients with Alzheimerís disease (AD). Secondary, to evaluate two doses of dronabinol in improving the patientís global functioning and to determine the effects of two doses of dronabinol on the caregiverís burden, strain (distress), and quality of life.

Design: A phase II, open-label, eight-week study in a total of 54 patients with AD. Twenty-seven patients were randomly assigned to Group 1ódronabinol 2.5 mg bid and 27 to Group 2ódronabinol 5.0 mg bid. The primary efficacy measurement was the Cohen-Mansfield Agitation Inventory (CMAI), a 38-item rating scale that evaluates the prevalence of pathological and disruptive behaviors, rating each on a seven-point scale of frequency ranging from 0 to 6. The secondary efficacy measurements were the Caregiverís Burden Inventory (CBI), CGI Severity of Alzheimerís Disease (CGI-S AD), Instrumental Activities of Daily Living scale (IADL), and Mini-Mental State Examination (MMSE).

Results: Significant reductions in CMAI scores were observed at both dronabinol dose levels (2.5: P<0.001, 5.0: P=0.024). The difference between the two groups was not statistically significant. Percent reductions in CMAI scores were statistically significant for both groups (2.5: P<0.001, 5.0: P=0.048). There was a trend toward a decrease in CBI scores, with no statistical difference between treatment groups. There was a trend toward a decrease in CGI-S AD scores in the dronabinol 5.0-mg bid group. There was a trend toward an increase in IADL scores with no difference between groups. There was no difference between groups in MMSE.
Conclusion: The results from the CMAI assessment indicated that dronabinol at both 2.5 mg bid and 5.0 mg bid were effective treatments for behavioral agitation in community-dwelling AD patients. There was not a significant difference between the doses of dronabinol in CMAI scores and most secondary efficacy parameters.

Benefit: Dronabinol was found to be an effective treatment for behavioral agitation in community-dwelling patients with AD.

Route(s)Oral
Dose(s)2 x 2,5 mg or 2 x 5 mg
Duration (days)56
Participants54 patients with AD
DesignOpen study
Type of publicationMeeting abstract
Address of author(s)Monmouth Medical Center, Long Branch, NJ, USA
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